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 In this section:

                Health Fraud Scams

Health Fraud Scams

                        El Fraude en la Salud Home
          For Consumers
          Health Fraud Scams
          Health Fraud Product DatabaseHealth Fraud Scams Health Fraud Product Database
  
  	
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    PrintThis list includes unapproved products that have been subject to FDA health fraud* related violations. These products have been cited in warning letters, online advisory letters, recalls, public notifications, and press announcements for issues varying from products marketed as dietary supplements claiming to cure, mitigate, treat or prevent disease, to the use of undeclared ingredients or new dietary ingredients.

This list only includes a small fraction of the potentially hazardous products marketed to consumers online and in retail establishments. Even if a product is not included in this list, consumers should exercise caution before using certain products.

For more information, see the **Medication Health Fraud** and **Health Fraud Scams** webpages.

Search Database

(Table results update automatically as you type)

Date
			Product1
			Firm
			Firm Address
			Source/URL(s)
			Subject
			Action
			Program Area(s)
			Additional Outcome11/29/2023
			Magnum XXL 9980
			Meta Herbal
			E. Hampton, NY
			amazon.com
			Undeclared sildenafil
			Recall
			Drugs11/21/2023
			Neptune's Fix
			n/a
			n/a
			n/a
			Contains tianeptine
			Alert
			Drugs11/17/2023
			Himalayan Pain Relief Tea
			WS Global, Inc
			Brooklyn, NY
			himalayan-painrelieftea.com
			Undeclared diclofenac and dexamethasone
			Public Notification
			Drugs
			Recall11/17/2023
			Tepee Herbal Tea
			n/a
			n/a
			amazon.com
			Undeclared piroxicam
			Public Notification
			Drugs11/17/2023
			Notoginseng Formula Special Gout Granule
			n/a
			n/a
			ebay.com
			Undeclared dexamethasone and diclofenac
			Public Notification
			Drugs11/03/2023
			Dr. Ergin's SugarMD Advanced Glucose Support
			n/a
			n/a
			sugarmds.com
			Undeclared Glyburide and Metformin
			Public Notification
			Drugs
			Recall10/19/2023
			The Rock
			Noah’s Wholesale, LLC
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs
			Recall09/29/2023
			Reumo Flex
			n/a
			n/a
			botanical-be.com
			Undeclared diclofenac
			Public Notification
			Drugs
			Recall09/29/2023
			Kuka Flex Forte
			n/a
			n/a
			botanical-be.com
			Undeclared diclofenac
			Public Notification
			Drugs
			Recall08/31/2023
			Tapee Tea
			n/a
			n/a
			tapeetea.com
			Undeclared dexamethasone and piroxicam
			Public Notification
			Drugs08/22/2023
			BIG GUYS Male Energy Supplement
			n/a
			n/a
			amazon.com
			Undeclared sildenafil
			Public Notification
			Drugs08/22/2023
			Mens Maximum Energy Supplement
			n/a
			n/a
			amazon.com
			Undeclared sildenafil
			Public Notification
			Drugs08/22/2023
			Round 2
			n/a
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs08/22/2023
			Genergy
			n/a
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs08/22/2023
			WeFun
			n/a
			n/a
			amazon.com; eshoponlineusa.com
			Undeclared sildenafil
			Public Notification
			Drugs
			Recall08/22/2023
			X MAX Triple Shot Energy Honey
			n/a
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs08/09/2023
			Vegetal Vigra 200mg
			n/a
			n/a
			APG Seven, Inc.
			Undeclared sildenafil
			Public Notification
			Drugs05/11/2023
			V=GRA GOLD 500mg
			n/a
			n/a
			Various
			Undeclared sildenafil
			Public Notification
			Drugs05/08/2023
			New Fast-Act Rheumatism Capsule
			n/a
			n/a
			Various
			Undeclared indomethacin
			Public Notification
			Drugs05/08/2023
			Fast-Act Rheuma Capsule
			n/a
			n/a
			Various
			Undeclared prednisone-21-acetate and piroxicam
			Public Notification
			Drugs05/08/2023
			UA-Block
			n/a
			n/a
			Various
			Undeclared indomethacin
			Public Notification
			Drugs05/05/2023
			Platinum 69000 Rhino 69
			n/a
			n/a
			Various
			Undeclared sildenafil
			Public Notification
			Drugs05/05/2023
			Power Plus Desire
			n/a
			n/a
			Various
			Undeclared sildenafil
			Public Notification
			Drugs05/05/2023
			Rhino 7S Type F3 7000
			n/a
			n/a
			Various
			Undeclared sildenafil and acetaminophen
			Public Notification
			Drugs05/05/2023
			Phentamene XT
			n/a
			n/a
			Various
			Undeclared DMAA
			Public Notification
			Foods05/04/2023
			Hard Steel 300K
			n/a
			n/a
			Various
			Undeclared tadalafil
			Public Notification
			Drugs05/04/2023
			Diamond Girl Lite
			n/a
			n/a
			Various
			Undeclared sildenafil
			Public Notification
			Drugs05/04/2023
			Special Edition Platinum 10K
			n/a
			n/a
			Various
			Undeclared tadalafil and vardenafil
			Public Notification
			Drugs05/01/2023
			NORF 20
			n/a
			n/a
			International Mail Shipments
			Undeclared acetaminophen, salicylic acid, and theophylline
			Public Notification
			Drugs04/19/2023
			DYNAMITE Male Sexual Enhancement
			n/a
			n/a
			gearisle.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs04/19/2023
			NUX Male Sexual Enhancement
			n/a
			n/a
			gearisle.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs04/19/2023
			Pro Power Knight Plus 2550mg
			n/a
			n/a
			gearisle.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs04/13/2023
			AK Forte
			n/a
			n/a
			suprimoimports.com
			Undeclared diclofenac, dexamethasone, and methocarbamol
			Public Notification
			Drugs04/07/2023
			Tantra Jelly Herbal Jelly for Him
			n/a
			n/a
			International Mail Shipments
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs04/07/2023
			American Bangster Black Label Optimum Formula 4000
			n/a
			n/a
			americanbangster.com
			Undeclared tadalafil
			Public Notification
			Drugs04/07/2023
			American Bangster Optimum Formula 3000
			n/a
			n/a
			americanbangster.com
			Undeclared tadalafil and sildenafil
			Public Notification
			Drugs04/07/2023
			NORF 20
			n/a
			n/a
			International Mail Shipments
			Undeclared acetaminophen, salicylic acid, and theophylline
			Public Notification
			Drugs02/08/2023
			Alfia Weight Loss Capsules
			n/a
			n/a
			alfia.com
			Undeclared sibutramine
			Public Notification
			Drugs02/07/2023
			PrimeZen Black 6000
			n/a
			n/a
			voltcandy.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			Recall02/02/2023
			MANNERS Energy Boost
			n/a
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs12/21/2022
			B.B. Clear Dark Spot Remover Cream
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			Amos Make Me White in 7 Days
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			African Queen Strong Bleaching Treatment
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			Light & Natural CAROTONE Black Spot Corrector CREME B.S.C.
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			HIYADY Glutatione Cream White & Bright
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			Aneeza Gold Beauty Face Cream
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			Collagen Plus - Vit E Cream, Night Cream
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			Skin care & Cosmetic MSII Express Peeling
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			Skin care & Cosmetic MSII Whitening Peeling
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			Ling Zhi BB Whitening Cream
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			La Tia Mana Crema Limpiadora y Curativa
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			Be Be Special Cream
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			Be Be Special Cream CCM/Yellow
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			CCM Perfect 365 White Cream
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs12/21/2022
			CCM Special Cream Turmeric
			n/a
			n/a
			Various
			Skin Product with Mercury and/or Hydroquinone
			Public Notification
			Cosmetics/Drugs11/21/2022
			JACK'D Sexual Enhancement Liquid
			n/a
			n/a
			Various
			Undeclared sildenafil
			Public Notification
			Drugs11/21/2022
			JACK'D Sexual Enhancement Capsules
			n/a
			n/a
			Various
			Undeclared sildenafil
			Public Notification
			Drugs11/14/2022
			Arterosil
			Calroy Health Sciences, LLC
			14362 N Frank Lloyd Wright, Suite 1000 Scottsdale, AZ 85260
			arterosil.com
			New Drug/Misbranded
			Warning Letter
			Foods
			Warning Letter Close-Out Letter11/14/2022
			CoQ10 Ubiquinol
			Anabolic Laboratories Inc
			26021 Commercentre Dr. Lake Forest, CA 92630-8853
			anaboliclabs.com
			New Drug/Misbranded
			Warning Letter
			Foods11/14/2022
			PrimePolicosanol Microtabs
			Anabolic Laboratories Inc
			26021 Commercentre Dr. Lake Forest, CA 92630-8853
			anaboliclabs.com
			New Drug/Misbranded
			Warning Letter
			Foods11/14/2022
			BPS-5
			Healthy Trends Worldwide, LLC
			11011 Spring Point Cir Riverview, FL 33579-4303
			goldenafter50.com
			New Drug/Misbranded
			Warning Letter
			Foods11/14/2022
			Blood Pressure Support
			Chambers' Apothecary
			278 Lincoln Way          East Chambersburg, PA 17201
			chambersapothecary.com
			New Drug/Misbranded
			Warning Letter
			Foods11/14/2022
			CoEnzyme Q10 products
			Chambers' Apothecary
			278 Lincoln Way          East Chambersburg, PA 17201
			chambersapothecary.com
			New Drug/Misbranded
			Warning Letter
			Foods11/14/2022
			iwi Cholesterol
			iwi
			2800 Post Oak Blvd Suite 5858 Houston, TX 77056
			iwilife.com
			New Drug/Misbranded
			Warning Letter
			Foods11/14/2022
			Cholesterol Command
			BergaMet North America LLC
			6445 S. Tenaya Way Suite B110 Las Vegas, NV      89113-1989
			bergametna.com
			New Drug/Misbranded
			Warning Letter
			Foods11/14/2022
			CholestAid
			Essential Elements
			675 N. 2800 W #101 Lindon, UT 84042
			essentialelementsnutrition.com
			New Drug/Misbranded
			Warning Letter
			Foods09/28/2022
			Wonder Pill Capsules
			Proper Trade LLC/My Stellar Lifestyle
			n/a
			amazon.com; walmart.com
			Undeclared tadalafil
			Recall
			Drugs08/02/2022
			SANGTER Energy Supplement, 3000mg
			Distributor RFR, LLC
			Miami, FL
			sangter.com and retail stores
			Undeclared sildenafil
			Recall
			Drugs
			Public Notification07/28/2022
			Honeymoon Exclusive For Men & Women
			n/a
			n/a
			Examination of imported goods
			Undeclared tadalafil and sildenafil
			Public Notification
			Drugs07/25/2022
			Sustango
			Ultra Supplement LLC
			Wilmington, DE
			amazon.com
			Undeclared tadalafil
			Recall
			Drugs07/22/2022
			Lipopastilla + Gold Max
			n/a
			n/a
			lipopastillas.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs07/15/2022
			Adam's Secret Extra Strength Blue
			n/a
			n/a
			adamssecret.com
			Undeclared tadalafil
			Public Notification
			Drugs07/15/2022
			Adam's Secret Extra Strength Purple
			n/a
			n/a
			adamssecret.com
			Undeclared tadalafil and sildenafil
			Public Notification
			Drugs07/15/2022
			Adam's Secret Extra Strength Amazing Black
			n/a
			n/a
			adamssecret.com
			Undeclared tadalafil
			Public Notification
			Drugs07/15/2022
			Adam's Secret Extra Strength 300 Platinum (White Packaging)
			n/a
			n/a
			adamssecret.com
			Undeclared tadalafil
			Public Notification
			Drugs06/27/2022
			Launch Sequence Capsules
			Loud Muscle Science, LLC
			n/a
			amazon.com, amazon.ca, ebay.com, and retail stores
			Undeclared tadalafil
			Recall
			Drugs06/27/2022
			Launch Sequence Euphoria Capsules
			Loud Muscle Science, LLC
			n/a
			amazon.com, amazon.ca, ebay.com, and retail stores
			Undeclared tadalafil
			Recall
			Drugs06/27/2022
			Launch Sequence Aphrodisia Capsules
			Loud Muscle Science, LLC
			n/a
			amazon.com, amazon.ca, ebay.com, and retail stores
			Undeclared tadalafil
			Recall
			Drugs04/25/2022
			Kingdom Honey Royal Honey VIP
			Shopaax.com
			2 Burleigh Ct., Newark, DE 19702
			shopaax.com
			Undeclared sildenafil
			Public Notification
			Drugs
			Warning Letter

			Recall04/25/2022
			Cougar Secret Honey VIP
			n/a
			n/a
			greenvalleyshops.com
			Undeclared sildenafil
			Public Notification
			Drugs04/25/2022
			Medcare Golden Royal Honey
			n/a
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs04/25/2022
			HoneyGizerTM
			n/a
			n/a
			amazon.com
			Undeclared sildenafil
			Public Notification
			Drugs04/25/2022
			ETUMAX VIP Royal Honey for Him
			n/a
			n/a
			honeyworldusa.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs04/25/2022
			Erkexin
			n/a
			n/a
			aliexpress.com
			Undeclared sildenafil
			Public Notification
			Drugs04/25/2022
			Royal Honey VIP
			Thirsty Run LLC / US Royal Honey LLC
			6841 Ternes St. Dearborn, MI 4812
			thirstyrun.com; usroyalhoney.com
			Undeclared tadalafil
			Public Notification
			Drugs
			Warning Letter04/25/2022
			Secret Miracle Honey (for Women)
			n/a
			n/a
			usroyalhoney.com
			Undeclared sildenafil
			Public Notification
			Drugs04/25/2022
			Secret Miracle Honey (for Men)
			n/a
			n/a
			etsy.com
			Undeclared sildenafil
			Public Notification
			Drugs04/25/2022
			Vital Honey
			MKS Enterprise, LLC
			59 Paulison Ave. #13 Passaic, NJ 0705
			wholesaleonline1.com; thirstyrun.com
			Undeclared tadalafil
			Public Notification
			Drugs
			Warning Letter; Warning Letter; Recall04/25/2022
			Helmi's Honey VIP
			n/a
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs04/25/2022
			X Rated Honey for Men
			1am USA Incorporated dba Pleasure Products USA
			6603 Crimson Lane Barnhart, MO 63012
			pleasureproductsusa.com; amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs
			Warning Letter04/20/2022
			Ortiga Mas Ajo Rey Extra Forte
			n/a
			n/a
			ebay.com
			Undeclared diclofenac, dexamethasone and methocarbamol
			Public Notification
			Drugs
			Alert04/20/2022
			Ortiga Mas Ajo Rey
			n/a
			n/a
			amazon.com
			Undeclared diclofenac
			Public Notification
			Drugs
			Alert04/20/2022
			Artri King
			n/a
			n/a
			amazon.com, latinfoodsmarket.com, walmart.com
			Undeclared dexamethasone and diclofenac
			Public Notification
			Drugs
			Alert

			Recall

			Additional Recall

			Additional Recall03/04/2022
			Wonderful Honey
			n/a
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs02/10/2022
			Rise Up Red Edition Capsules
			Positive-Health
			n/a
			amazon.com
			Undeclared tadalafil
			Recall
			Drugs02/09/2022
			Red Mammoth capsules
			Celebrate Today
			n/a
			amazon.com
			Undeclared tadalafil and sildenafil
			Recall
			Drugs02/08/2022
			The Red Pill
			Your Favorite Shop
			n/a
			amazon.com
			Undeclared tadalafil
			Recall
			Drugs02/08/2022
			MAC DADDY PURPLE capsules
			ABC SALES 1 INC
			n/a
			amazon.com
			Undeclared tadalafil
			Recall
			Drugs02/08/2022
			MAC DADDY RED capsules
			ABC SALES 1 INC
			n/a
			amazon.com
			Undeclared tadalafil and sildenafil
			Recall
			Drugs02/04/2022
			MegMan Performance Booster capsules
			Junp LLC
			n/a
			amazon.com
			Undeclared tadalafil
			Recall
			Drugs01/28/2022
			Hard Dawn Rise and Shine capsules
			Esupplementsales, LLC
			n/a
			amazon.com
			Undeclared tadalafil
			Recall
			Drugs01/07/2022
			Taewon Liar
			Various Distributors
			n/a
			etsy.com
			Undeclared meloxicam
			Public Notification
			Drugs01/05/2022
			Artri Ajo King
			Various Distributors
			n/a
			amazon.com
			Undeclared diclofenac
			Public Notification
			Drugs01/02/2022
			Nasitrol
			Amcyte Pharma, Inc.
			5400 Carillon Point, Kirkland, WA 98004
			nasitrol.com
			Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs12/08/2021
			Avaphinal
			Various Distributors
			n/a
			walmart.com
			Undeclared sildenafil
			Public Notification
			Drugs
			News Release12/08/2021
			Brahma Male Enhancement
			Various Distributors
			n/a
			walmart.com
			Undeclared sildenafil
			Public Notification
			Drugs
			News Release12/08/2021
			Hard AF!
			Various Distributors
			n/a
			walmart.com
			Undeclared sildenafil and acetaminophen
			Public Notification
			Drugs
			News Release12/08/2021
			Helmi’s Honey VIP
			Various Distributors
			n/a
			walmart.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release12/08/2021
			Jaguar Power
			Various Distributors
			n/a
			walmart.com
			Undeclared sildenafil
			Public Notification
			Drugs
			News Release12/08/2021
			Kangaroo Intense Alpha 3000
			Various Distributors
			n/a
			walmart.com
			Undeclared sildenafil
			Public Notification
			Drugs
			News Release12/08/2021
			Magnum XXL 9800
			Various Distributors
			n/a
			walmart.com
			Undeclared sildenafil
			Public Notification
			Drugs
			News Release12/08/2021
			Pink Pussycat
			Various Distributors
			n/a
			walmart.com
			Undeclared sildenafil
			Public Notification
			Drugs
			News Release

			Recall12/08/2021
			Go On Red
			Various Distributors
			n/a
			walmart.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release12/01/2021
			“VitaStik” product line
			VitaStik, Inc.
			433 N. Camden Dr. #600, Beverly Hills, CA 90210
			vitastik.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Drugs
			More Information12/01/2021
			“VitaCig products”
			VitaCig, Inc.
			2375 Watermill Dr., Orange Park, FL 32073
			vitaciggroup.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Drugs
			More Information12/01/2021
			“vaporizer” and “diffuser” products
			NV Nutrition, LLC
			4700 140th Ave N. Suite 112, Clearwater, FL 33762
			nutriair.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Drugs
			More Information12/01/2021
			“B12 VITAMINVAPE”
			Vitamin Vape, Inc.
			6320 S. Sandhill Road, Suite 5, Las Vegas, NV 89120
			vitaminvape.co
			Unapproved New Drugs/Misbranded
			Warning Letter
			Drugs
			More Information12/01/2021
			“Caffeine Pen”
			Eagle Energy USA, Inc.
			27 N. 27th Street, Suite 2102, Billings, MT 59101-2347
			eagle.energy
			Unapproved New Drugs/Misbranded
			Warning Letter
			Drugs
			More Information11/18/2021
			Crocin products
			Saffron Health Sciences
			13 Dexter Rd, E Brunswick, NJ 08816
			saffronhealthsci.com;
			facebook.com/saffronhealthsci/;
			amazon.com;
			New Drug/Misbranded
			Warning Letter
			Foods09/28/2021
			Non-alcohol-based topical antiseptic product, microSURETM
			Strategia Project Management, Inc.
			1000 Jorie Blvd. Suite 370 Oak Brook, IL 60523
			microsure.com;
			twitter.com/microsure_;
			facebook.com/microSURE.HandSanitizer
			Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs09/22/2021
			Arsyn
			Supplement Science Corp. d/b/a Condemned Labz
			2139 East 3rd Street Brooklyn, NY 11223
			condemnedlabz.com/;
			facebook.com/condemnedlabzofficial
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/22/2021
			ConvictStim
			Supplement Science Corp. d/b/a Condemned Labz
			2139 East 3rd Street Brooklyn, NY 11223
			condemnedlabz.com/;
			facebook.com/condemnedlabzofficial
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/22/2021
			Humaslin
			Supplement Science Corp. d/b/a Condemned Labz
			2139 East 3rd Street Brooklyn, NY 11223
			condemnedlabz.com/;
			facebook.com/condemnedlabzofficial
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/22/2021
			Thyrogenic
			Supplement Science Corp. d/b/a Condemned Labz
			2139 East 3rd Street Brooklyn, NY 11223
			condemnedlabz.com/;
			facebook.com/condemnedlabzofficial
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/22/2021
			DNA Dispatch
			Supplement Science Corp. d/b/a Condemned Labz
			2139 East 3rd Street Brooklyn, NY 11223
			condemnedlabz.com/;
			facebook.com/condemnedlabzofficial
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/10/2021
			“Glyco-Well”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			“Pan-Gest”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			“Heart-Line”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			“Aspara-Can”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			“Cherry Gold”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			“H.H.S. Formula”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			“Brain Balance”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			“Passionate Pursuit”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			“Better Mood”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			“Male Prosexual”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			“Ear Well”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			“Pink Lady”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			“Eye-C”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/10/2021
			Hemorr-Norm”
			Holographic Health, Inc.
			516 E. Market Street Kingsport, TN 37660
			holographichealth.com
			New Drug/Misbranded
			Warning Letter
			Foods09/07/2021
			“Black Indian Salve,” also referred to as “Indian Herb,” “X,” and “Black Salve”
			McDaniel Water LLC
			363 Ricketson Road
			Amistad, NM 88410
			mcdanielwater.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Drugs09/07/2021
			CuraLin
			Radhanite, LLC d/b/a Curalife Ltd
			208 Paterson Plank Rd. Union City, NJ 07087-2826
			curalife.com/; instagram.com/curalife/ and https://www.facebook.com/curalife/
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			Sugar Balance
			Aceva, LLC
			624 West Glen Ave. Peoria, IL 61614
			aceva.com/; twitter.com/acevahealth and https://www.facebook.com/acevanutrition
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			Diabetes Support
			Ar-Rahman Pharm LLC
			14625 Baltimore Ave., Suite 885 Laurel, MD 20707
			ar‐rahmahpharm.com/; instagram.com/arrahmahpharm/; facebook.com/ArRahmahPharm
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			“Lysulin Weight Loss Shake”
			Lysulin, Inc.
			4930 Bradshaw Ct. San Diego, CA 92130
			lysulin.com;
			instagram.com/lysulin_usa/;
			facebook.com/lysulindiabetesmanagement
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			“Lysulin Diabetes and Prediabetes Chewables”
			Lysulin, Inc.
			4930 Bradshaw Ct. San Diego, CA 92130
			lysulin.com;
			instagram.com/lysulin_usa/;
			facebook.com/lysulindiabetesmanagement
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			“Lysulin Diabetes and Prediabetes Liquid”
			Lysulin, Inc.
			4930 Bradshaw Ct. San Diego, CA 92130
			lysulin.com;
			instagram.com/lysulin_usa/;
			facebook.com/lysulindiabetesmanagement
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			“Lysulin Diabetes and Prediabetes Capsules”
			Lysulin, Inc.
			4930 Bradshaw Ct. San Diego, CA 92130
			lysulin.com;
			instagram.com/lysulin_usa/;
			facebook.com/lysulindiabetesmanagement
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			“Lysulin Diabetes and Prediabetes Powder”
			Lysulin, Inc.
			4930 Bradshaw Ct. San Diego, CA 92130
			lysulin.com;
			instagram.com/lysulin_usa/;
			facebook.com/lysulindiabetesmanagement
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			“Berry Gen Sugar Control”
			Live Good Inc.
			860 NW 27th St. Suite 051-51425 Miami, FL 33122
			berrygen.com/;
			facebook.com/ColagenoBerryGenRestore/;
			instagram.com/berrygenrestore/
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			"GLUCOTYPE2”
			Phytag Labs
			12600 Hill Country Boulevard Suite R-275 Bee Cave, TX 78738
			phytagelaboratories.com;
			amazon.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			“Diabetic Support Formula”
			Nuturna International LLC
			390 North Orange Ave. Suite 2300 Orlando, FL 32801
			nuturna.com;
			amazon.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			“Diabetes Doctor Pre-Diabetes”
			Pharmaganics LLC
			8475 Parley Lake Rd Waconia, MN 55387
			diabetesdoctor.com;
			facebook.com/naturaldiabetesdoctor;
			instagram.com/diabetesdoctor/
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			“Diabetes Doctor Blood Sugar 24 Hour”
			Pharmaganics LLC
			8475 Parley Lake Rd Waconia, MN 55387
			diabetesdoctor.com;
			facebook.com/naturaldiabetesdoctor;
			instagram.com/diabetesdoctor/
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			DiabetesSupport
			Metamune Inc
			8001 S 194th St. Kent, WA 98032-1126
			bodymune.com/; facebook.com/Bodymune/; amazon.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods09/07/2021
			Diabalance Diabetes Supplement
			Holistic Healer & Wellness Center, Inc.
			3998 Clippert St. P.O. Box 23017 Dearborn, MI 48123
			holistichealeronline.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods08/31/2021
			Muscle Test
			New York Nutrition Company / American Metabolix
			1083 FM 812 Unit B Cedar Creek, TX 78612-3689
			americanmetabolix.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods08/31/2021
			Banish
			New York Nutrition Company / American Metabolix
			1083 FM 812 Unit B Cedar Creek, TX 78612-3689
			americanmetabolix.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods08/31/2021
			Ketogenic Diet Aid
			New York Nutrition Company / American Metabolix
			1083 FM 812 Unit B Cedar Creek, TX 78612-3689
			americanmetabolix.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods08/31/2021
			Keto Friendly Collagen
			New York Nutrition Company / American Metabolix
			1083 FM 812 Unit B Cedar Creek, TX 78612-3689
			americanmetabolix.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods08/31/2021
			Exile Euphoric Weight Loss
			New York Nutrition Company / American Metabolix
			1083 FM 812 Unit B Cedar Creek, TX 78612-3689
			americanmetabolix.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods08/31/2021
			Exile Super Shock
			New York Nutrition Company / American Metabolix
			1083 FM 812 Unit B Cedar Creek, TX 78612-3689
			americanmetabolix.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods08/31/2021
			Havok Hardcore
			New York Nutrition Company / American Metabolix
			1083 FM 812 Unit B Cedar Creek, TX 78612-3689
			americanmetabolix.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods08/31/2021
			Keto Pump in Watermelon and Grape Flavors
			New York Nutrition Company / American Metabolix
			1083 FM 812 Unit B Cedar Creek, TX 78612-3689
			americanmetabolix.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods08/26/2021
			Fibrolief Support Formula
			Fibromyalgia Treatment Group - FTG, LLC
			1236 Lone Creek Drive Eagle, ID 83616
			fibromyalgiatreatmentgroup.com/landers/1/;
			fibrolief.com;
			neuropathytreatmentgroup.com;
			nerverenew.com;
			facebook.com/fibrolief
			New Drug/Misbranded
			Warning Letter
			Foods08/26/2021
			Nerve Renew
			Fibromyalgia Treatment Group - FTG, LLC
			1236 Lone Creek Drive Eagle, ID 83616
			fibromyalgiatreatmentgroup.com/landers/1/;
			fibrolief.com;
			neuropathytreatmentgroup.com;
			nerverenew.com;
			facebook.com/fibrolief
			New Drug/Misbranded
			Warning Letter
			Foods08/26/2021
			Neuro Boost Optimizer
			Fibromyalgia Treatment Group - FTG, LLC
			1236 Lone Creek Drive Eagle, ID 83616
			fibromyalgiatreatmentgroup.com/landers/1/;
			fibrolief.com;
			neuropathytreatmentgroup.com;
			nerverenew.com;
			facebook.com/fibrolief
			New Drug/Misbranded
			Warning Letter
			Foods08/26/2021
			Immune Support
			Fibromyalgia Treatment Group - FTG, LLC
			1236 Lone Creek Drive Eagle, ID 83616
			fibromyalgiatreatmentgroup.com/landers/1/;
			fibrolief.com;
			neuropathytreatmentgroup.com;
			nerverenew.com;
			facebook.com/fibrolief
			New Drug/Misbranded
			Warning Letter
			Foods08/24/2021
			ISM5 Invisi Smart Mask
			Invisi Smart Technologies UK LTD
			112 Cumberland House80 Scrubs Lane London NW10 6RF United Kingdom
			invisismart.com/;
			shop.invisismart.com/;
			twitter.com/InvisiSmart
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019
			Warning Letter
			Devices08/24/2021
			ISM5 Invisi Smart Mask (Black Edition)
			Invisi Smart Technologies UK LTD
			112 Cumberland House80 Scrubs Lane London NW10 6RF United Kingdom
			invisismart.com/;
			shop.invisismart.com/;
			twitter.com/InvisiSmart
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019
			Warning Letter
			Devices08/24/2021
			ISM30 Invisi Smart Mask
			Invisi Smart Technologies UK LTD
			112 Cumberland House80 Scrubs Lane London NW10 6RF United Kingdom
			invisismart.com/;
			shop.invisismart.com/;
			twitter.com/InvisiSmart
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019
			Warning Letter
			Devices08/19/2021
			“Patanjali Coronil Kit” (aka “Patanjali Divya Swasari Coronil Kit”)
			Mahita, LLC dba PushMyCart
			415 Hillingdon Way Suwanee, GA 30024
			pushmycart.com;
			facebook.com/pushmycartglobal
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs08/19/2021
			“Dr. Reckeweg Arsenic Album Dilution 30 CH"
			Mahita, LLC dba PushMyCart
			415 Hillingdon Way Suwanee, GA 30024
			pushmycart.com;
			facebook.com/pushmycartglobal
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs08/19/2021
			“SBL Arsenicum Album Dilution 30 CH"
			Mahita, LLC dba PushMyCart
			415 Hillingdon Way Suwanee, GA 30024
			pushmycart.com;
			facebook.com/pushmycartglobal
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs08/19/2021
			“Kerala Ayurveda Balarishtam"
			Mahita, LLC dba PushMyCart
			415 Hillingdon Way Suwanee, GA 30024
			pushmycart.com;
			facebook.com/pushmycartglobal
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs08/19/2021
			“Kottakkal Balarishtam”
			Mahita, LLC dba PushMyCart
			415 Hillingdon Way Suwanee, GA 30024
			pushmycart.com;
			facebook.com/pushmycartglobal
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs08/18/2021
			Themra Epimedyumlu Bitkisel Karisimli Macun
			Various Distributors
			n/a
			Examination of imported goods - shipment addressed to an Amazon fulfillment center
			Undeclared sildenafil
			Public Notification
			Drugs08/10/2021
			Various salt scrub products
			Secret of the Islands
			5326 Bush River Rd. Columbia, SC 29212
			secretoftheislands.com;
			facebook.com/SecretoftheIslands
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs08/06/2021
			Modified Perilla & Mentha
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			Empowered Cordyceps
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			Empowered Reishi
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			AllerEase
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			Empowered Eleuthro
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			Sui Bian Guo
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			Chinese Herbal Shampoo
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			Jade Dew Ointment
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			Stop Pain Tincture
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			Dr. Bob’s Medicated Oil
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			Cut & Sore Ointment
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			E-C-Z Ointment
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			Organic Cactus Seed (Prickly Pear) Oil Antioxidant Facial Serum
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			Skin Soothing Ointment
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			Dragon’s Blood Liniment
			Blue Poppy Enterprises Inc
			4804 SE 69th Avenue Portland, OR 97206
			bluepoppy.com;
			peopleherbs.com;
			facebook.com/ PeoplesHerbs/;
			twitter.com/peoples herbs;
			instagram.com/peoples_herbs/;&
			amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods08/06/2021
			"Genesis Ultra Gold"
			Genesis Nutrition Ultra Slim dba Genesis Ultra Slim
			10108 NW 77th Street Doral, FL 33178
			fastweightlossgarcinia.com;
			ketoultraslimplus.com;
			facebook.com/genesisultraslim;
			twitter.com/genesis_slim;
			instagram.com/genesis_slim/
			Unapproved New Drugs/Misbranded
			Warning Letter
			Drugs08/03/2021
			Non-alcohol-based consumer antiseptic nasal product, "NanoBio® Protect Over-The-Counter Nasal Antiseptic"
			Blue Willow Biologics
			2311 Green Road Ann Arbor, MI 48105
			nanobioprotect.com;
			bluewillow.com;
			cvs.com/shop/nanobio-protect-nasal-antiseptic-prodid-160333
			Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs
			*08/02/2021
			365 Skinny High Intensity Pills
			Je Dois L’avoir Boutique
			n/a
			jedoisavoir2020.com
			Undeclared sibutramine
			Recall
			Drugs08/02/2021
			365 Skinny Emergency Boutique
			Je Dois L’avoir Boutique
			n/a
			jedoisavoir2020.com
			Undeclared sibutramine
			Recall
			Drugs07/29/2021
			Neutralization Antibody Test kit (Colloidal Gold, Fluorescent, Elisa)
			Lepu Medical Technology -Beijing- Co., Ltd.
			No. 37 Chaoqian Rd.Changping Qu Beijing Shi,China
			n/a
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices07/29/2021
			SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
			Lepu Medical Technology -Beijing- Co., Ltd.
			No. 37 Chaoqian Rd.Changping Qu Beijing Shi,China
			n/a
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices07/29/2021
			Saliva Antigen Rapid Test
			Lepu Medical Technology -Beijing- Co., Ltd.
			No. 37 Chaoqian Rd.Changping Qu Beijing Shi,China
			n/a
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices07/28/2021
			Melatonin
			Dr. Thomas Polucki Upper Cervical Chiropractic, Inc.
			25050 Peachland Ave #105 Newhall, CA 91321
			getbetterxshop.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods07/28/2021
			Nitric Oxide Support
			Dr. Thomas Polucki Upper Cervical Chiropractic, Inc.
			25050 Peachland Ave #105 Newhall, CA 91321
			getbetterxshop.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods07/26/2021
			Hydro Pinapple [sic] Burn
			Max Health; eBay Seller - jongu 4308
			Houston, TX
			ebay.com
			Undeclared sibutramine and desisobutylbenzylsibutramine
			Public Notification
			Drugs
			Recall07/26/2021
			“COVx-RDA Nasal Antigen Test”
			Vivera Pharmaceuticals, Inc.
			26021 Pala Drive - St A Mission Viejo, CA 92691
			viveracovid19.com/covx-rda/;
			viverapharmaceuticals.com/products/
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices07/26/2021
			“COVxRDA Saliva Antigen Test”
			Vivera Pharmaceuticals, Inc.
			26021 Pala Drive - St A Mission Viejo, CA 92691
			viveracovid19.com/covx-rda/;
			viverapharmaceuticals.com/products/
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices07/26/2021
			VIVERA + OMECARE Home Specimen Collection Kit
			Vivera Pharmaceuticals, Inc.
			26021 Pala Drive - St A Mission Viejo, CA 92691
			hometestbox.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices07/23/2021
			Organic Blueberry White & Green Tea
			TeaTaze, LLC
			1203 N Fieldcrest St Wichita, KS 67212
			teataze.com;
			facebook.com/teatazetea
			New Drug/Misbranded
			Warning Letter
			Foods07/23/2021
			Clean Green Energy Detox Tea
			TeaTaze, LLC
			1203 N Fieldcrest St Wichita, KS 67212
			teataze.com;
			facebook.com/teatazetea
			New Drug/Misbranded
			Warning Letter
			Foods07/23/2021
			Tokusen Hinshucha Fuji Midori Green Tea
			TeaTaze, LLC
			1203 N Fieldcrest St Wichita, KS 67212
			teataze.com;
			facebook.com/teatazetea
			New Drug/Misbranded
			Warning Letter
			Foods07/23/2021
			Vibrant Green Tea
			TeaTaze, LLC
			1203 N Fieldcrest St Wichita, KS 67212
			teataze.com;
			facebook.com/teatazetea
			New Drug/Misbranded
			Warning Letter
			Foods07/23/2021
			Caffeine-Free Herbal Energy Tea
			TeaTaze, LLC
			1203 N Fieldcrest St Wichita, KS 67212
			teataze.com;
			facebook.com/teatazetea
			New Drug/Misbranded
			Warning Letter
			Foods07/23/2021
			Ignited Oolong Slimming Tea
			TeaTaze, LLC
			1203 N Fieldcrest St Wichita, KS 67212
			teataze.com;
			facebook.com/teatazetea
			New Drug/Misbranded
			Warning Letter
			Foods07/23/2021
			Power Puer Aged Tea
			TeaTaze, LLC
			1203 N Fieldcrest St Wichita, KS 67212
			teataze.com;
			facebook.com/teatazetea
			New Drug/Misbranded
			Warning Letter
			Foods07/23/2021
			Silver Tranquility White Tea
			TeaTaze, LLC
			1203 N Fieldcrest St Wichita, KS 67212
			teataze.com;
			facebook.com/teatazetea
			New Drug/Misbranded
			Warning Letter
			Foods07/22/2021
			“Regular Strength Nasadol CBD Nasal Spray”
			MB Solutions, LLC/BioSpectrum CBD
			5980 Executive Dr. Suite A Madison, WI 53719
			biospectrumcbd.com;
			nasadol.com;
			facebook.com/BioSpectrumCBD;
			instagram.com/biospectrum.cbd/
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2021
			“Extra Strength Nasadol CBD Nasal Spray”
			MB Solutions, LLC/BioSpectrum CBD
			5980 Executive Dr. Suite A Madison, WI 53719
			biospectrumcbd.com;
			nasadol.com;
			facebook.com/BioSpectrumCBD;
			instagram.com/biospectrum.cbd/
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2021
			“Pain Relief Roll-On”
			MB Solutions, LLC/BioSpectrum CBD
			5980 Executive Dr. Suite A Madison, WI 53719
			biospectrumcbd.com;
			nasadol.com;
			facebook.com/BioSpectrumCBD;
			instagram.com/biospectrum.cbd/
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2021
			“CBD Oil Tincture” (500 mg and 1500 mg)
			MB Solutions, LLC/BioSpectrum CBD
			5980 Executive Dr. Suite A Madison, WI 53719
			biospectrumcbd.com;
			nasadol.com;
			facebook.com/BioSpectrumCBD;
			instagram.com/biospectrum.cbd/
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2021
			“Sour Gummy Worms” (250 mg and 500 mg)
			MB Solutions, LLC/BioSpectrum CBD
			5980 Executive Dr. Suite A Madison, WI 53719
			biospectrumcbd.com;
			nasadol.com;
			facebook.com/BioSpectrumCBD;
			instagram.com/biospectrum.cbd/
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2021
			“CBD Gummy Worms” (250 mg and 500 mg)
			MB Solutions, LLC/BioSpectrum CBD
			5980 Executive Dr. Suite A Madison, WI 53719
			biospectrumcbd.com;
			nasadol.com;
			facebook.com/BioSpectrumCBD;
			instagram.com/biospectrum.cbd/
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2021
			“CBD Peach Rings” (250 mg and 500 mg)
			MB Solutions, LLC/BioSpectrum CBD
			5980 Executive Dr. Suite A Madison, WI 53719
			biospectrumcbd.com;
			nasadol.com;
			facebook.com/BioSpectrumCBD;
			instagram.com/biospectrum.cbd/
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2021
			“Watermelon Slices” (250 mg, 500 mg, and 1000 mg)
			MB Solutions, LLC/BioSpectrum CBD
			5980 Executive Dr. Suite A Madison, WI 53719
			biospectrumcbd.com;
			nasadol.com;
			facebook.com/BioSpectrumCBD;
			instagram.com/biospectrum.cbd/
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2021
			“CBD Gummy Bears” (500 mg and 1000 mg)
			MB Solutions, LLC/BioSpectrum CBD
			5980 Executive Dr. Suite A Madison, WI 53719
			biospectrumcbd.com;
			nasadol.com;
			facebook.com/BioSpectrumCBD;
			instagram.com/biospectrum.cbd/
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2021
			“1,000mg Canine CBD Oil”
			MB Solutions, LLC/BioSpectrum CBD
			5980 Executive Dr. Suite A Madison, WI 53719
			biospectrumcbd.com;
			nasadol.com;
			facebook.com/BioSpectrumCBD;
			instagram.com/biospectrum.cbd/
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2021
			“CBD Dog Treats”
			MB Solutions, LLC/BioSpectrum CBD
			5980 Executive Dr. Suite A Madison, WI 53719
			biospectrumcbd.com;
			nasadol.com;
			facebook.com/BioSpectrumCBD;
			instagram.com/biospectrum.cbd/
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/20/2021
			Lion’s Mane
			Brilliant Enterprises LLC
			621 Main Street, Unit 182Gaylord, MI 49735
			levelupmushrooms.com;
			instagram.com/levelupmushrooms;
			twitter.com/LvlUpMushrooms
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods07/20/2021
			BoomChaga
			Brilliant Enterprises LLC
			621 Main Street, Unit 182Gaylord, MI 49735
			levelupmushrooms.com;
			instagram.com/levelupmushrooms;
			twitter.com/LvlUpMushrooms
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods07/20/2021
			CordaCex
			Brilliant Enterprises LLC
			621 Main Street, Unit 182Gaylord, MI 49735
			levelupmushrooms.com;
			instagram.com/levelupmushrooms;
			twitter.com/LvlUpMushrooms
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods07/20/2021
			LVL:MAX
			Brilliant Enterprises LLC
			621 Main Street, Unit 182Gaylord, MI 49735
			levelupmushrooms.com;
			instagram.com/levelupmushrooms;
			twitter.com/LvlUpMushrooms
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods07/20/2021
			“Germaphobe’s Delight Spray”
			Jordan’s Crossing Herbal Connections
			568 County Road 2307 Barnsdall, OK 74002
			jordanscrossing.net;
			youtube.com/watch?v=dWCJdjcjbfM
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs07/22/2021
			Miss Slim
			HIS
			Palisades Park, NJ
			missslimusa.com
			Undeclared sibutramine
			Recall
			Drugs07/19/2021
			Alpha Male Plus
			Alpha Male Plus
			n/a
			alphamaleplus.us
			Undeclared tadalafil
			Recall
			Drugs07/14/2021
			Diabetic Patch (aka Herbal Diabetic Patch)
			Healthy Livin' Solutions
			9169 W State St #628
			Garden City, Idaho 83714
			healthylivin.solutions
			New Drug
			Online Advisory Letter
			Drugs07/09/2021
			X Rated Honey For Men
			Various Distributors
			n/a
			adameve.com
			Undeclared tadalafil
			Public Notification
			Drugs07/09/2021
			“COVIGEN AG-1 Covid-19 Self Detection Kit”
			Biopolygen Corp.
			2207 East Carson St Carson, CA 90810
			biopolygen.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices07/09/2021
			“COVIDEX AB-1 Covid-19 Self Detection Kit”
			Biopolygen Corp.
			2207 East Carson St Carson, CA 90810
			biopolygen.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices07/09/2021
			“COVID-19 Antigen and Antibody Combo Set”
			Biopolygen Corp.
			2207 East Carson St Carson, CA 90810
			biopolygen.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices07/09/2021
			“Saliva Test Kit”
			USH Diagnostics, Inc./covidinstanttest.net
			3456 E. 155th St. Kansas City, MO 64147
			covidinstanttest.net;
			ushealthdiagnostics.com/;
			facebook.com/covid19instanttest;
			twitter.com/covidathometest;
			instagram.com/covid19instanttest
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices07/09/2021
			“Rapid 10 Minute Antigen Test”
			USH Diagnostics, Inc./covidinstanttest.net
			3456 E. 155th St. Kansas City, MO 64147
			covidinstanttest.net;
			ushealthdiagnostics.com/;
			facebook.com/covid19instanttest;
			twitter.com/covidathometest;
			instagram.com/covid19instanttest
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices07/09/2021
			“Rapid Dual Antibody Test”
			USH Diagnostics, Inc./covidinstanttest.net
			3456 E. 155th St. Kansas City, MO 64147
			covidinstanttest.net;
			ushealthdiagnostics.com/;
			facebook.com/covid19instanttest;
			twitter.com/covidathometest;
			instagram.com/covid19instanttest
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices07/08/2021
			Immune Booster
			3RD Day Nutraceuticals, LLC
			225 N Main St, Suite 404 Bristol, CT 06010
			3rddaynutra.com
			New Drug/Misbranded
			Warning Letter
			Foods07/08/2021
			Allergy Support
			3RD Day Nutraceuticals, LLC
			225 N Main St, Suite 404 Bristol, CT 06010
			3rddaynutra.com
			New Drug/Misbranded
			Warning Letter
			Foods07/08/2021
			Inflammatory Response Support
			3RD Day Nutraceuticals, LLC
			225 N Main St, Suite 404 Bristol, CT 06010
			3rddaynutra.com
			New Drug/Misbranded
			Warning Letter
			Foods07/08/2021
			Revive & Recover
			3RD Day Nutraceuticals, LLC
			225 N Main St, Suite 404 Bristol, CT 06010
			3rddaynutra.com
			New Drug/Misbranded
			Warning Letter
			Foods07/07/2021
			Halodine nasal and oral “sanitizer” product lines that include, Halodine Nasal Antiseptic Swabstick, Halodine Nasal Antiseptic, Halodine Oral Antiseptic Spray and Halodine Oral Rinse
			Halodine, LLC
			111 NE 1st St, Suite 806 Miami, FL 33132-2506
			halodine.com;
			shop.halodine.com;
			twitter.com/TheHalodine;
			facebook.com/halodine
			Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs07/01/2021
			Genesis Ultra Slim Gold
			Genesis Nutrition Ultra Slim dba Genesis Ultra Slim
			10108 NW 77th StreetDoral, FL 33178
			fastweightlossgarcinia.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs
			Warning Letter07/01/2021
			High Vitality Full Spectrum Liquid Multi-Vitamin
			Phoenix Nutritionals, Inc.
			4727 Terrace Drive San Diego, CA 92116-2515
			phoenixvitamins.com;
			healthyinformation.com;
			facebook.com/phoenixnutritionalsinc/
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			High Vitality Caps
			Phoenix Nutritionals, Inc.
			4727 Terrace Drive San Diego, CA 92116-2515
			phoenixvitamins.com;
			healthyinformation.com;
			facebook.com/phoenixnutritionalsinc/
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			Best Cholesterol Support
			Phoenix Nutritionals, Inc.
			4727 Terrace Drive San Diego, CA 92116-2515
			phoenixvitamins.com;
			healthyinformation.com;
			facebook.com/phoenixnutritionalsinc/
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			Blood Sugar Support
			Phoenix Nutritionals, Inc.
			4727 Terrace Drive San Diego, CA 92116-2515
			phoenixvitamins.com;
			healthyinformation.com;
			facebook.com/phoenixnutritionalsinc/
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			Maximum Stress Support
			Phoenix Nutritionals, Inc.
			4727 Terrace Drive San Diego, CA 92116-2515
			phoenixvitamins.com;
			healthyinformation.com;
			facebook.com/phoenixnutritionalsinc/
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			Complete Joint Support
			Phoenix Nutritionals, Inc.
			4727 Terrace Drive San Diego, CA 92116-2515
			phoenixvitamins.com;
			healthyinformation.com;
			facebook.com/phoenixnutritionalsinc/
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			Natural Anti-Inflammatory Support
			Phoenix Nutritionals, Inc.
			4727 Terrace Drive San Diego, CA 92116-2515
			phoenixvitamins.com;
			healthyinformation.com;
			facebook.com/phoenixnutritionalsinc/
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			Best Immune Support
			Phoenix Nutritionals, Inc.
			4727 Terrace Drive San Diego, CA 92116-2515
			phoenixvitamins.com;
			healthyinformation.com;
			facebook.com/phoenixnutritionalsinc/
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			Altitude RX
			Biomedical Research Laboratories, LLC
			7590 Fay Ave Suite 202 La Jolla, CA 92037-4885
			brlsports.com
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			Flexify
			Biomedical Research Laboratories, LLC
			7590 Fay Ave Suite 202 La Jolla, CA 92037-4885
			brlsports.com
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			Calm Legs
			Biomedical Research Laboratories, LLC
			7590 Fay Ave Suite 202 La Jolla, CA 92037-4885
			nativeorigins.com;
			brlscience.com;
			facebook.com/mynativeorigins
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			Collagen Peptides
			Biomedical Research Laboratories, LLC
			7590 Fay Ave Suite 202 La Jolla, CA 92037-4885
			nativeorigins.com;
			brlscience.com;
			facebook.com/mynativeorigins
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			Prohemia
			Biomedical Research Laboratories, LLC
			7590 Fay Ave Suite 202 La Jolla, CA 92037-4885
			nativeorigins.com;
			brlscience.com;
			facebook.com/mynativeorigins
			New Drug/Misbranded
			Warning Letter
			Foods07/01/2021
			Trimmunity
			Biomedical Research Laboratories, LLC
			7590 Fay Ave Suite 202 La Jolla, CA 92037-4885
			nativeorigins.com;
			brlscience.com;
			facebook.com/mynativeorigins
			New Drug/Misbranded
			Warning Letter
			Foods06/30/2021
			365 SKINNY High Intensity
			Je Dois Lavoir LLC
			n/a
			jedoisavoir2020.com; facebook.com/jdl2020; instagram.com/j_d_l2020
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall

			Warning Letter06/23/2021
			ProbioticXL
			Great Healthworks, Inc.
			4150 SW 28th Way Fort Lauderdale, FL 33312-5201
			greathealthworks.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods06/23/2021
			OmegaXL
			Great Healthworks, Inc.
			4150 SW 28th Way Fort Lauderdale, FL 33312-5201
			greathealthworks.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods06/22/2021
			Immune Builder
			Pacific Center of Health/Pacific Center of Health & Acupuncture
			8555 Aero Dr. Suite 107 San Diego, CA 92123
			pacificcenterofhealth.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs06/22/2021
			High Risk Environment Pack- NO SYMPTOMS
			Pacific Center of Health/Pacific Center of Health & Acupuncture
			8555 Aero Dr. Suite 107 San Diego, CA 92123
			pacificcenterofhealth.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs06/22/2021
			Anti-Viral Herbal Formula
			Pacific Center of Health/Pacific Center of Health & Acupuncture
			8555 Aero Dr. Suite 107 San Diego, CA 92123
			pacificcenterofhealth.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs06/22/2021
			Anti-Viral Herbal Pack – ACUTE ILLINESS
			Pacific Center of Health/Pacific Center of Health & Acupuncture
			8555 Aero Dr. Suite 107 San Diego, CA 92123
			pacificcenterofhealth.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs06/22/2021
			Kitchen Sink
			Pacific Center of Health/Pacific Center of Health & Acupuncture
			8555 Aero Dr. Suite 107 San Diego, CA 92123
			pacificcenterofhealth.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs06/22/2021
			Lung Formula Dry Cough
			Pacific Center of Health/Pacific Center of Health & Acupuncture
			8555 Aero Dr. Suite 107 San Diego, CA 92123
			pacificcenterofhealth.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs06/22/2021
			Lung Formula Wet Cough
			Pacific Center of Health/Pacific Center of Health & Acupuncture
			8555 Aero Dr. Suite 107 San Diego, CA 92123
			pacificcenterofhealth.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs06/22/2021
			Colloidal Silver
			Pacific Center of Health/Pacific Center of Health & Acupuncture
			8555 Aero Dr. Suite 107 San Diego, CA 92123
			pacificcenterofhealth.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs06/22/2021
			Post COVID-19 Recovery
			Pacific Center of Health/Pacific Center of Health & Acupuncture
			8555 Aero Dr. Suite 107 San Diego, CA 92123
			pacificcenterofhealth.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs06/10/2021
			Super Tonic
			Natural Hope Herbals, LLC
			670 Phillips Road Millersburg, PA 17061-9044
			naturalhopeherbals.com
			New Drug/Misbranded
			Warning Letter
			Foods06/10/2021
			Respiratory Aid
			Natural Hope Herbals, LLC
			670 Phillips Road Millersburg, PA 17061-9044
			naturalhopeherbals.com
			New Drug/Misbranded
			Warning Letter
			Foods06/10/2021
			Wild Cherry Honey Syrup
			Natural Hope Herbals, LLC
			670 Phillips Road Millersburg, PA 17061-9044
			naturalhopeherbals.com
			New Drug/Misbranded
			Warning Letter
			Foods06/10/2021
			Ivy Oaky
			Natural Hope Herbals, LLC
			670 Phillips Road Millersburg, PA 17061-9044
			naturalhopeherbals.com
			New Drug/Misbranded
			Warning Letter
			Foods06/10/2021
			Jewelweed Spray Combo Pack
			Natural Hope Herbals, LLC
			670 Phillips Road Millersburg, PA 17061-9044
			naturalhopeherbals.com
			New Drug/Misbranded
			Warning Letter
			Foods06/10/2021
			Jewelweed Spray
			Natural Hope Herbals, LLC
			670 Phillips Road Millersburg, PA 17061-9044
			naturalhopeherbals.com
			New Drug/Misbranded
			Warning Letter
			Foods06/10/2021
			Prostate Health
			Natural Hope Herbals, LLC
			670 Phillips Road Millersburg, PA 17061-9044
			naturalhopeherbals.com
			New Drug/Misbranded
			Warning Letter
			Foods06/10/2021
			Kidney/Bladder
			Natural Hope Herbals, LLC
			670 Phillips Road Millersburg, PA 17061-9044
			naturalhopeherbals.com
			New Drug/Misbranded
			Warning Letter
			Foods06/10/2021
			Bone & Tissue Connect
			Natural Hope Herbals, LLC
			670 Phillips Road Millersburg, PA 17061-9044
			naturalhopeherbals.com
			New Drug/Misbranded
			Warning Letter
			Foods06/10/2021
			SARS-CoV-2 Antigen Rapid Qualitative Test
			Innova Medical Group, Inc.
			800 E. Colorado Blvd., Suite 288 Pasadena, CA 91101
			n/a
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices06/07/2021
			Travel Care Probiotic
			Flora Inc
			805 E. Badger Rd. Lynden, WA 98264-9502
			florahealth.com/us;
			pinterest.com/florahealth/
			New Drug/Misbranded
			Warning Letter
			Foods06/07/2021
			Sleep•Essence
			Flora Inc
			805 E. Badger Rd. Lynden, WA 98264-9502
			florahealth.com/us;
			pinterest.com/florahealth/
			New Drug/Misbranded
			Warning Letter
			Foods06/07/2021
			Cardio•Essence
			Flora Inc
			805 E. Badger Rd. Lynden, WA 98264-9502
			florahealth.com/us;
			pinterest.com/florahealth/
			New Drug/Misbranded
			Warning Letter
			Foods06/07/2021
			Grape Seed Extract Plus
			Flora Inc
			805 E. Badger Rd. Lynden, WA 98264-9502
			florahealth.com/us;
			pinterest.com/florahealth/
			New Drug/Misbranded
			Warning Letter
			Foods06/07/2021
			Elderberry+, Elderberry Crystals
			Flora Inc
			805 E. Badger Rd. Lynden, WA 98264-9502
			florahealth.com/us;
			pinterest.com/florahealth/
			New Drug/Misbranded
			Warning Letter
			Foods06/07/2021
			Flor•Essence
			Flora Inc
			805 E. Badger Rd. Lynden, WA 98264-9502
			florahealth.com/us;
			pinterest.com/florahealth/
			New Drug/Misbranded
			Warning Letter
			Foods06/07/2021
			Hydro-Therm Pumpkin Oil
			Flora Inc
			805 E. Badger Rd. Lynden, WA 98264-9502
			florahealth.com/us;
			pinterest.com/florahealth/
			New Drug/Misbranded
			Warning Letter
			Foods06/07/2021
			Pumpkin Oil
			Flora Inc
			805 E. Badger Rd. Lynden, WA 98264-9502
			florahealth.com/us;
			pinterest.com/florahealth/
			New Drug/Misbranded
			Warning Letter
			Foods06/07/2021
			Mãnuka Honey
			Flora Inc
			805 E. Badger Rd. Lynden, WA 98264-9502
			florahealth.com/us;
			pinterest.com/florahealth/
			New Drug/Misbranded
			Warning Letter
			Foods06/04/2021
			Miss Slim
			Various Distributors
			n/a
			amazon.com
			Undeclared sibutramine
			Public Notification
			Drugs06/04/2021
			Adam’s Secret Extra Strength 2000
			Various Distributors
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs05/27/2021
			Berberine
			Fresh Nutrition Inc
			23860 Nicole Way Yorba Linda, CA 92887-5626
			fresh-nutrition.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/27/2021
			Echinacea
			Fresh Nutrition Inc
			23860 Nicole Way Yorba Linda, CA 92887-5626
			fresh-nutrition.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/27/2021
			European Elderberry
			Fresh Nutrition Inc
			23860 Nicole Way Yorba Linda, CA 92887-5626
			fresh-nutrition.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/27/2021
			Milk Thistle
			Fresh Nutrition Inc
			23860 Nicole Way Yorba Linda, CA 92887-5626
			fresh-nutrition.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/27/2021
			Lion’s Mane Mushroom
			Fresh Nutrition Inc
			23860 Nicole Way Yorba Linda, CA 92887-5626
			fresh-nutrition.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/27/2021
			Turmeric Curcumin
			Fresh Nutrition Inc
			23860 Nicole Way Yorba Linda, CA 92887-5626
			fresh-nutrition.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/27/2021
			Fish Oil
			Fresh Nutrition Inc
			23860 Nicole Way Yorba Linda, CA 92887-5626
			fresh-nutrition.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/27/2021
			Green Lipped Mussels
			Fresh Nutrition Inc
			23860 Nicole Way Yorba Linda, CA 92887-5626
			fresh-nutrition.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/27/2021
			Various chlorine dioxide products, including “OCLO 3000”
			OCLO LLC/OCLO Nanotechnology Science
			220 SW 9th Ave, #506 Hallandale, FL 33009
			dioxidodecloro.us; facebook.com/Hallandale.Beach.2018/; oclo.ecrater.com/index.php
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs05/26/2021
			Super Naturals brand IBSolution
			JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health
			1309 1⁄2 S. Roxbury Dr. Los Angeles, CA 90035
			supernaturalshealth.com;
			ibsformula.com;
			amazon.com;
			facebook.com/supernaturalshealth;
			facebook.com/ibsrelief
			New Drug/Misbranded
			Warning Letter
			Foods05/26/2021
			Premium Probiotic
			JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health
			1309 1⁄2 S. Roxbury Dr. Los Angeles, CA 90035
			supernaturalshealth.com;
			ibsformula.com;
			amazon.com;
			facebook.com/supernaturalshealth;
			facebook.com/ibsrelief
			New Drug/Misbranded
			Warning Letter
			Foods05/26/2021
			Sleep Solution
			JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health
			1309 1⁄2 S. Roxbury Dr. Los Angeles, CA 90035
			supernaturalshealth.com;
			ibsformula.com;
			amazon.com;
			facebook.com/supernaturalshealth;
			facebook.com/ibsrelief
			New Drug/Misbranded
			Warning Letter
			Foods05/26/2021
			Joint Solution
			JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health
			1309 1⁄2 S. Roxbury Dr. Los Angeles, CA 90035
			supernaturalshealth.com;
			ibsformula.com;
			amazon.com;
			facebook.com/supernaturalshealth;
			facebook.com/ibsrelief
			New Drug/Misbranded
			Warning Letter
			Foods05/26/2021
			Ultra Omega Fish Oil
			JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health
			1309 1⁄2 S. Roxbury Dr. Los Angeles, CA 90035
			supernaturalshealth.com;
			ibsformula.com;
			amazon.com;
			facebook.com/supernaturalshealth;
			facebook.com/ibsrelief
			New Drug/Misbranded
			Warning Letter
			Foods05/24/2021
			Brazilian Propolis Extract
			Beauty & Spa Concepts, DBA Beenefits
			10765 Southwest 108th Ave. #308 Miami, FL 33176
			beenefits.com;
			instagram.com/beenefits/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods05/24/2021
			CoronaBox
			Everything Health LLC
			1445 293rd Ave NE Carnation, WA 98014
			ssnaturalhealing.com;
			facebook.com/ssdallastx/;
			instagram.com/tamikamoseley/;
			twitter.com/sicklesolution
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019(COVID-19)
			Warning Letter
			Foods05/20/2021
			“NaturaCure”
			NS Products, Inc.
			11721 State Ave Marysville, WA 98271
			naturacure.net
			New Drug/Misbranded
			Warning Letter
			Foods05/20/2021
			“OVOENERGENTM CoenzymeQ10”
			Fertility Nutraceuticals LLC
			21 E 69th St New York, NY 10021
			fertilitynutraceuticals.com;
			fertilitysupplementstore.com
			New Drug/Misbranded
			Warning Letter
			Foods05/20/2021
			“FERTINATAL® DHEA”
			Fertility Nutraceuticals LLC
			21 E 69th St New York, NY 10021
			fertilitynutraceuticals.com;
			fertilitysupplementstore.com
			New Drug/Misbranded
			Warning Letter
			Foods05/20/2021
			“CONFLAM- ForteTM”
			Fertility Nutraceuticals LLC
			21 E 69th St New York, NY 10021
			fertilitynutraceuticals.com;
			fertilitysupplementstore.com
			New Drug/Misbranded
			Warning Letter
			Foods05/20/2021
			“CONCEPTION MEN Male Fertility”
			EU Natural Inc.
			2654 W Horizon Ridge Pkwy Ste B5-93 Henderson, NV 89052
			store.eunatural.com;
			instagram.com/eunatural/
			New Drug/Misbranded
			Warning Letter
			Foods05/20/2021
			“CONCEPTION Female Fertility Prenatal”
			EU Natural Inc.
			2654 W Horizon Ridge Pkwy Ste B5-93 Henderson, NV 89052
			store.eunatural.com;
			instagram.com/eunatural/
			New Drug/Misbranded
			Warning Letter
			Foods05/20/2021
			“ConceiveEasy”
			LeRoche Benicoeur dba ConceiveEasy
			1130 Fremont Blvd #301 Seaside, CA 93955
			conceiveeasy.com
			New Drug/Misbranded
			Warning Letter
			Foods05/20/2021
			“FertilHerb for Women”
			Sal Nature LLC/FertilHerb
			1621 Central Ave Cheyenne, WY 82001-4531
			fertilherb.com
			New Drug/Misbranded
			Warning Letter
			Foods05/19/2021
			“BIOCENCE WS Multi-use Selective Antibacterial / Antiviral Human OTC Drug”
			BGP, LLC
			2118 Wilshire Blvd Santa Monica, CA 90403
			biocence.com;
			facebook.com/Biocence;
			instagram.com/biocence
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs05/12/2021
			Lipodrene w/25mg Ephedra Extract Dietary Supplement
			Hi-Tech Pharmaceuticals. Inc
			Norcross, GA
			n/a
			Presence of 1,4-dimethylamylamine (DMAA)
			Recall
			Foods05/10/2021
			Collagen Endurance Plus
			Great Lakes Gelatin Company
			253 Commerce Dr., Ste 101 Grayslake, IL 60030
			greatlakesgelatin.com
			facebook.com/greatlakesgel/;
			pinterest.com/greatlakesgel/
			New Drug/Misbranded
			Warning Letter
			Foods05/10/2021
			Keto Collagen + MCT
			Great Lakes Gelatin Company
			253 Commerce Dr., Ste 101 Grayslake, IL 60030
			greatlakesgelatin.com
			facebook.com/greatlakesgel/;
			pinterest.com/greatlakesgel/
			New Drug/Misbranded
			Warning Letter
			Foods05/10/2021
			Collagen Hydrolysate (10 oz unflavored and vanilla, mixed berry, lemon + lime, apple + cucumber, chocolate, and chai flavors, 16 oz unflavored, Convenience Pack (20 count unflavored), 8lb unflavored)
			Great Lakes Gelatin Company
			253 Commerce Dr., Ste 101 Grayslake, IL 60030
			greatlakesgelatin.com
			facebook.com/greatlakesgel/;
			pinterest.com/greatlakesgel/
			New Drug/Misbranded
			Warning Letter
			Foods05/06/2021
			DISINFECTTM & SHIELD HAND SANITIZER non-alcohol based hand sanitizer products
			Disinfect & Shield
			1616 Fountain View Drive Houston, TX 77057
			disinfectandshield.com
			Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs05/06/2021
			Non-alcohol based hand sanitizer products
			Covalon Technologies Inc.
			1660 Tech Avenue, Unit 5 Mississauga ON L4W 5S7 Canada
			covaguard.com;
			instagram.com/covaguard/;
			facebook.com/covaguard/
			Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs05/04/2021
			GenBody COVID-19 IgM/IgG test
			Baltimore Beauty Security Square Mall
			6901 Security Square Blvd. #343 Baltimore, MD 21244
			n/a
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices05/04/2021
			GenBody COVID-19 Ag test
			Baltimore Beauty Security Square Mall
			6901 Security Square Blvd. #343 Baltimore, MD 21244
			n/a
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices04/29/2021
			Tummy Tuck Max
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs04/29/2021
			Enerup Premium
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs04/29/2021
			ErectMax
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs04/29/2021
			Vital Sex
			Various Distributors
			
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs04/29/2021
			Iodine Detoxified
			Crown Wellness, Inc.
			421 Grand Concourse #1
			Miami Shores, FL 33183

			9999 NE 2 Ave, Suite 209E
			Miami Shores, FL 33138
			crownwellness.com
			New Drug/Misbranded
			Warning Letter
			Foods04/29/2021
			Karma Cleanse
			Crown Wellness, Inc.
			421 Grand Concourse #1
			Miami Shores, FL 33183

			9999 NE 2 Ave, Suite 209E
			Miami Shores, FL 33138
			crownwellness.com
			New Drug/Misbranded
			Warning Letter
			Foods04/29/2021
			E3 Digestive Enzymes Supreme
			Crown Wellness, Inc.
			421 Grand Concourse #1
			Miami Shores, FL 33183

			9999 NE 2 Ave, Suite 209E
			Miami Shores, FL 33138
			crownwellness.com
			New Drug/Misbranded
			Warning Letter
			Foods04/29/2021
			Diatomaceous Earth Powder (DE)
			Crown Wellness, Inc.
			421 Grand Concourse #1
			Miami Shores, FL 33183

			9999 NE 2 Ave, Suite 209E
			Miami Shores, FL 33138
			crownwellness.com
			New Drug/Misbranded
			Warning Letter
			Foods04/29/2021
			E3 Renew Me/B.G. Blue Green Algae
			Crown Wellness, Inc.
			421 Grand Concourse #1
			Miami Shores, FL 33183

			9999 NE 2 Ave, Suite 209E
			Miami Shores, FL 33138
			crownwellness.com
			New Drug/Misbranded
			Warning Letter
			Foods04/29/2021
			Clinic’s Choice CLO2
			Crown Wellness, Inc.
			421 Grand Concourse #1
			Miami Shores, FL 33183

			9999 NE 2 Ave, Suite 209E
			Miami Shores, FL 33138
			crownwellness.com
			New Drug/Misbranded
			Warning Letter
			Foods04/28/2021
			Herpes Protocol Ultimate Kit
			The Underground Cure
			P.O. Box 1111
			Snellville, GA 30078
			theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC
			New Drug
			Online Advisory Letter
			Foods; Drugs04/28/2021
			Herpes Protocol Vitamin Kit
			The Underground Cure
			P.O. Box 1111
			Snellville, GA 30078
			theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC
			New Drug
			Online Advisory Letter
			Foods; Drugs04/28/2021
			Olive Leaf Extract
			The Underground Cure
			P.O. Box 1111
			Snellville, GA 30078
			theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC
			New Drug
			Online Advisory Letter
			Foods; Drugs04/28/2021
			DMSO Liquid 70/30
			The Underground Cure
			P.O. Box 1111
			Snellville, GA 30078
			theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC
			New Drug
			Online Advisory Letter
			Foods; Drugs04/28/2021
			Gentiana Complex
			The Underground Cure
			P.O. Box 1111
			Snellville, GA 30078
			theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC
			New Drug
			Online Advisory Letter
			Foods; Drugs04/27/2021
			“HM-FORMULA”
			NeuroHydrate LLC
			4637 Main St, Unit 5 Bridgeport, CT 06606-1838
			neurohydrate.com/
			New Drug/Misbranded
			Warning Letter
			Foods04/21/2021
			Pixie Dust Magnesium
			DRF LLC
			United States
			doctorfarrah.com; drfarrah.online
			New Drug/Misbranded
			Warning Letter
			Foods04/21/2021
			Mega-Dose Vitamin C
			DRF LLC
			United States
			doctorfarrah.com; drfarrah.online
			New Drug/Misbranded
			Warning Letter
			Foods04/21/2021
			Boston C
			DRF LLC
			United States
			doctorfarrah.com; drfarrah.online
			New Drug/Misbranded
			Warning Letter
			Foods04/21/2021
			“Red 65”
			North American Hirudin Biotech Products Inc.
			2531 Broadway, Suite A Everett, WA 98201
			ushirudin.com/;
			naturalhirudin.com/;
			buyred65.com/
			New Drug/Misbranded
			Warning Letter
			Foods04/21/2021
			“Hirudin”
			North American Hirudin Biotech Products Inc.
			2531 Broadway, Suite A Everett, WA 98201
			ushirudin.com/;
			naturalhirudin.com/;
			buyred65.com/
			New Drug/Misbranded
			Warning Letter
			Foods04/15/2021
			Balanced Kollagen
			Molecular BioLife International, Inc.
			200 W 16th St Bldg B Sheldon, IA 51201-2008
			molecularbiolife.com
			New Drug/Misbranded
			Warning Letter
			Foods04/15/2021
			Shark 2 Collagen
			Molecular BioLife International, Inc.
			200 W 16th St Bldg B Sheldon, IA 51201-2008
			molecularbiolife.com
			New Drug/Misbranded
			Warning Letter
			Foods04/13/2021
			“COVID-19 Formula”
			Trinity Natural Health & Pain Management, Inc.
			1100 NE 125th Street, Suite #203A North Miami, FL 33161
			trinity-naturalhealth.com/;
			facebook.com/TrinityNaturalSupplements
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs04/13/2021
			Apple Cider Vinegar Capsules
			Orphic Nutrition
			2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
			orphicnutrition.comand;
			amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
			New Drug/Misbranded
			Warning Letter
			Foods04/13/2021
			Ashwagandha Capsules
			Orphic Nutrition
			2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
			orphicnutrition.comand;
			amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
			New Drug/Misbranded
			Warning Letter
			Foods04/13/2021
			Garcinia Cambogia Capsules
			Orphic Nutrition
			2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
			orphicnutrition.comand;
			amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
			New Drug/Misbranded
			Warning Letter
			Foods04/13/2021
			Premium Collagen Peptides Capsules
			Orphic Nutrition
			2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
			orphicnutrition.comand;
			amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
			New Drug/Misbranded
			Warning Letter
			Foods04/13/2021
			Elderberry Gummies
			Orphic Nutrition
			2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
			orphicnutrition.comand;
			amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
			New Drug/Misbranded
			Warning Letter
			Foods04/13/2021
			Omega 3 Fish Oil Softgels
			Orphic Nutrition
			2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
			orphicnutrition.comand;
			amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
			New Drug/Misbranded
			Warning Letter
			Foods04/13/2021
			Turmeric Curcumin with Bioperin Capsules
			Orphic Nutrition
			2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
			orphicnutrition.comand;
			amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
			New Drug/Misbranded
			Warning Letter
			Foods04/13/2021
			“Covid-19 Test Kit”
			Anytime COVID Test LLC
			6615 West Boynton Beach Blvd., #181 Boynton Beach, FL 33437
			anytimecovidtest.com;
			mycovidtester.com;
			gotcovidtests.com;
			covidtestyou.com
			buymycovidtest.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices04/08/2021
			Alterra Sili-Mer G5
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Anemia
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Cancer (Piptopet)
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Cancer (Specific Remedy)
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Cataract-L
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Fracture
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Heart
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Heart Murmur
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Heartworm
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Hip Dysplasia
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Parvopet
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Seizurepet
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Thyroidpet
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			Virus Defense Kit, which includes your Immunopet, Silverpet, and Cordyceps
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/08/2021
			White Blood Cells
			Groupe Cyrenne Inc. dba HomeoAnimal
			1205 Des Chataigniers Quebec QC G3G 3C4 Canada
			homeoanimal.com;
			facebook.com/homeoanimal
			Unapproved New Animal Drug Products
			Warning Letter
			Veterinary04/07/2021
			Silver Soul Immune Support
			Allure Imports
			405 E Easterday Ave., Unit 2, Sault Sainte Marie, MI 49783
			facedoctor.ca;
			vitalityc60.com
			allureimports.com
			facebook.com/facedoctorca/;
			facebook.com/vitalityc60;
			instagram.com/facedoctor.ca/;
			twitter.com/FaceDoctorRx/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs, Veterinary04/07/2021
			Silver Soul Body Spray
			Allure Imports
			405 E Easterday Ave., Unit 2, Sault Sainte Marie, MI 49783
			facedoctor.ca;
			vitalityc60.com
			allureimports.com
			facebook.com/facedoctorca/;
			facebook.com/vitalityc60;
			instagram.com/facedoctor.ca/;
			twitter.com/FaceDoctorRx/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs, Veterinary04/07/2021
			Vitality C60
			Allure Imports
			405 E Easterday Ave., Unit 2, Sault Sainte Marie, MI 49783
			facedoctor.ca;
			vitalityc60.com
			allureimports.com
			facebook.com/facedoctorca/;
			facebook.com/vitalityc60;
			instagram.com/facedoctor.ca/;
			twitter.com/FaceDoctorRx/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs, Veterinary04/07/2021
			Puriton topical skin products
			About Mineral
			3063 W. Chapman Ave., #6301 Orange, CA 92868
			aboutmineral.com;
			facebook.com/aboutmineral;
			instagram.com/about_mineral/;
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs04/07/2021
			Colox
			Unived Inc
			16491 Scientific Way Irvine, CA 92618
			unived.us/; amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods04/07/2021
			CalDveg
			Unived Inc
			16491 Scientific Way Irvine, CA 92618
			unived.us/; amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods04/07/2021
			B12+D3
			Unived Inc
			16491 Scientific Way Irvine, CA 92618
			unived.us/; amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods04/07/2021
			D3+K2-7
			Unived Inc
			16491 Scientific Way Irvine, CA 92618
			unived.us/; amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods04/06/2021
			“Rapid COVID-19 Antigen Self Test Kit”
			Sethi Laboratories
			17290 Preston Road Suite 300 Dallas, TX 75252
			sethilaboratories.com;
			facebook.com/sethilabs;
			instagram.com/p/CGC8yKEHXZO;
			twitter.com/SethiLabsUS
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices04/06/2021
			“Rapid COVID-19 Antibody Self Test Kit”
			Sethi Laboratories
			17290 Preston Road Suite 300 Dallas, TX 75252
			sethilaboratories.com;
			facebook.com/sethilabs;
			instagram.com/p/CGC8yKEHXZO;
			twitter.com/SethiLabsUS
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices04/01/2021
			Purity Essential Oil Blend products
			Natural Adventure, LLC
			13765 SW 32nd Street Miramar, FL 33027
			mynaturaladventure.com;
			facebook.com/MyNatAdventure;
			instagram.com/mynatadventure/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs04/01/2021
			Purity Sanitizer with 70% Alcohol
			Natural Adventure, LLC
			13765 SW 32nd Street Miramar, FL 33027
			mynaturaladventure.com;
			facebook.com/MyNatAdventure;
			instagram.com/mynatadventure/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs03/30/2021
			Immune Bio Green Cell
			Immune & Genetics Protocols, LLC
			1655 SW 63rd ST RD Ocala, FL 34476
			biogreencell.com; facebook.com/BioGreenCell/
			New Drug/Misbranded
			Warning Letter
			Devices03/29/2021
			Formula I
			Nature's Pharmacy, LLC
			1565 195th Avenue
			Bloomer, WI 54724
			naturespharmacyllc.com
			New Drug
			Online Advisory Letter
			Foods; Drugs03/29/2021
			Formula II
			Nature's Pharmacy, LLC
			1565 195th Avenue
			Bloomer, WI 54724
			naturespharmacyllc.com
			New Drug
			Online Advisory Letter
			Foods; Drugs03/29/2021
			Formula III
			Nature's Pharmacy, LLC
			1565 195th Avenue
			Bloomer, WI 54724
			naturespharmacyllc.com
			New Drug
			Online Advisory Letter
			Foods; Drugs03/29/2021
			Formula IV
			Nature's Pharmacy, LLC
			1565 195th Avenue
			Bloomer, WI 54724
			naturespharmacyllc.com
			New Drug
			Online Advisory Letter
			Foods; Drugs03/29/2021
			Formula V
			Nature's Pharmacy, LLC
			1565 195th Avenue
			Bloomer, WI 54724
			naturespharmacyllc.com
			New Drug
			Online Advisory Letter
			Foods; Drugs03/29/2021
			Magnesium Transdermal Patches
			Better Supplement Solutions Inc. dba XanFree
			105 Overton St
			Deer Park, NY 11729
			xanfree.com;
			facebook.com/getxanfree
			New Drug
			Online Advisory Letter
			Foods; Drugs03/29/2021
			Tranquil Blend
			Better Supplement Solutions Inc. dba XanFree
			105 Overton St
			Deer Park, NY 11729
			xanfree.com;
			facebook.com/getxanfree
			New Drug
			Online Advisory Letter
			Foods; Drugs03/29/2021
			Tranquil Blend + Magnesium Transdermal Combo
			Better Supplement Solutions Inc. dba XanFree
			105 Overton St
			Deer Park, NY 11729
			xanfree.com;
			facebook.com/getxanfree
			New Drug
			Online Advisory Letter
			Foods; Drugs03/29/2021
			Yin-Yang Essence Men Power
			Various Distributors
			n/a
			ebay.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs03/29/2021
			Furious X 1350
			Various Distributors
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs03/29/2021
			Zing Plus
			Various Distributors
			n/a
			amazon.com
			Undeclared sildenafil
			Public Notification
			Drugs03/25/2021
			“Akcutest COVID-19 Antibody Test”
			Ikcon Investments, Inc dba Ikcon Medical
			14653 Caminito Lazanja San Diego, CA 92127
			ikconmedical.com; akcutestshop.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices03/25/2021
			“Lumigenik COVID-19 Antigen Rapid Test”
			Ikcon Investments, Inc dba Ikcon Medical
			14653 Caminito Lazanja San Diego, CA 92127
			ikconmedical.com; akcutestshop.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices03/24/2021
			“COVID-19 IgM/IgG Rapid Test”
			Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs
			424 S. Roadway New Orleans, LA 70124
			tmtestkits.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices03/19/2021
			Lipotriad Vision Support Plus
			Lipotriad LLC
			5 Sentry Parkway East Suite 210 Blue Bell, PA 19422
			lipotriadvitamins.com;
			facebook.com/LipotriadVitamins;
			twitter.com/Lipotriad
			New Drug/Misbranded
			Warning Letter
			Foods03/19/2021
			Lipotriad Dry Eye
			Lipotriad LLC
			5 Sentry Parkway East Suite 210 Blue Bell, PA 19422
			lipotriadvitamins.com;
			facebook.com/LipotriadVitamins;
			twitter.com/Lipotriad
			New Drug/Misbranded
			Warning Letter
			Foods03/19/2021
			Lipotriad Adult 50+
			Lipotriad LLC
			5 Sentry Parkway East Suite 210 Blue Bell, PA 19422
			lipotriadvitamins.com;
			facebook.com/LipotriadVitamins;
			twitter.com/Lipotriad
			New Drug/Misbranded
			Warning Letter
			Foods03/19/2021
			Lipotriad Visionary
			Lipotriad LLC
			5 Sentry Parkway East Suite 210 Blue Bell, PA 19422
			lipotriadvitamins.com;
			facebook.com/LipotriadVitamins;
			twitter.com/Lipotriad
			New Drug/Misbranded
			Warning Letter
			Foods03/18/2021
			“Long Island Biotech COVID-19 Antigen Rapid Test (Colloidal Gold)”
			Block Scientific
			22 Sawgrass Drive Bellport, NY 11713
			blockscientificstore.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices03/18/2021
			“QUIKPACII COVID-19 ANTIBODY TEST KIT”
			Block Scientific
			22 Sawgrass Drive Bellport, NY 11713
			blockscientificstore.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices03/18/2021
			"Magnesium Oil Spray"
			BioLyte Laboratories, LLC
			310 Northern Dr. NW, Grand Rapids, MI 49534
			N/A
			CGMP/Finished Pharmaceuticals/Adulterated
			Warning Letter
			Drugs03/18/2021
			"Pain Relief Cream"
			BioLyte Laboratories, LLC
			310 Northern Dr. NW Grand Rapids, MI 49534
			N/A
			CGMP/Finished Pharmaceuticals/Adulterated
			Warning Letter
			Drugs03/18/2021
			"Therapeutic Pain Gel"
			BioLyte Laboratories, LLC
			310 Northern Dr. NW, Grand Rapids, MI 49534
			N/A
			CGMP/Finished Pharmaceuticals/Adulterated
			Warning Letter
			Drugs03/18/2021
			"Silver Liquid Supplement"
			BioLyte Laboratories, LLC
			310 Northern Dr. NW, Grand Rapids, MI 49534
			N/A
			CGMP/Finished Pharmaceuticals/Adulterated
			Warning Letter
			Drugs03/18/2021
			"Silver Gel with Aloe"
			BioLyte Laboratories, LLC
			310 Northern Dr. NW, Grand Rapids, MI 49534
			N/A
			CGMP/Finished Pharmaceuticals/Adulterated
			Warning Letter
			Drugs03/18/2021
			"Silver Gel"
			BioLyte Laboratories, LLC
			310 Northern Dr. NW, Grand Rapids, MI 49534
			N/A
			CGMP/Finished Pharmaceuticals/Adulterated
			Warning Letter
			Drugs03/16/2021
			Fucoidan
			Anna Health, LLC
			9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550
			annahealth.com
			New Drug/Misbranded
			Warning Letter
			Foods03/16/2021
			Prostate Health
			Anna Health, LLC
			9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550
			annahealth.com
			New Drug/Misbranded
			Warning Letter
			Foods03/16/2021
			Children Liquid Vitamins
			Anna Health, LLC
			9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550
			annahealth.com
			New Drug/Misbranded
			Warning Letter
			Foods03/16/2021
			Immune Health
			Anna Health, LLC
			9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550
			annahealth.com
			New Drug/Misbranded
			Warning Letter
			Foods03/16/2021
			Fucoidan
			Duoc Thao Tre Xanh, LLC
			9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550
			duocthaotrexanh.com
			New Drug/Misbranded
			Warning Letter
			Foods03/16/2021
			Papaya Leaf Extract
			Duoc Thao Tre Xanh, LLC
			9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550
			duocthaotrexanh.com
			New Drug/Misbranded
			Warning Letter
			Foods03/16/2021
			Ganoderma Lucidum Red Reishi Mushroom
			Duoc Thao Tre Xanh, LLC
			9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550
			duocthaotrexanh.com
			New Drug/Misbranded
			Warning Letter
			Foods03/16/2021
			Immune Health
			Duoc Thao Tre Xanh, LLC
			9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550
			duocthaotrexanh.com
			New Drug/Misbranded
			Warning Letter
			Foods03/15/2021
			“ELIXICURE PAIN RELIEF with CBD” products
			Honest Globe, Inc.
			3605 West Macarthur Boulevard, Suite 701 Santa Ana, CA 92704-6845
			N/A
			CGMP/Finished Pharmaceuticals/Adulterated
			Warning Letter
			Drugs03/12/2021
			“ROSE FREQUENCY TONGUE TINCTURE”
			Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials
			351 NW Pleasant View Dr, Grants Pass OR 37526
			ravenscroftescentials.com; instagram.com/ravenscroftoils
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs03/12/2021
			"ELEVATION OF MIND AROMAMIST”
			Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials
			351 NW Pleasant View Dr, Grants Pass OR 37526
			ravenscroftescentials.com; instagram.com/ravenscroftoils
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs03/12/2021
			“HEALER’s CHAI AROMATEA & BREATH DROPS”
			Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials
			351 NW Pleasant View Dr, Grants Pass OR 37526
			ravenscroftescentials.com; instagram.com/ravenscroftoils
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs03/12/2021
			“AIR PURIFY AROMAMIST”
			Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials
			351 NW Pleasant View Dr, Grants Pass OR 37526
			ravenscroftescentials.com; instagram.com/ravenscroftoils
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs03/05/2021
			2 Own The Knight Silver 4000
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs03/05/2021
			Rhino SE7EN2
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs03/05/2021
			Stiff Rox
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs03/05/2021
			Titanium 18K
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs03/05/2021
			"IoWipe," Hand wipe product
			CAMA Wellness Center/IodoRios Company, LLC
			6782 Germantown Ave. Philadelphia, PA 19119
			cp.camacenter.com; facebook.com/IoWipe
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs03/01/2021
			"Balance CBD Drops"
			Cannafyl
			7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250
			cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs03/01/2021
			"Relief CBD Drops"
			Cannafyl
			7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250
			cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs03/01/2021
			"Relax CBD Drops"
			Cannafyl
			7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250
			cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs03/01/2021
			"Relief CBD Salve"
			Cannafyl
			7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250
			cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs03/01/2021
			“Immunoral”
			Ageless Global, LLC
			2722 S. West Temple, Salt Lake City, UT 84115
			agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs03/01/2021
			“Immune Plus”
			Ageless Global, LLC
			2722 S. West Temple, Salt Lake City, UT 84115
			agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs03/01/2021
			“MD Immune Support Spray”
			Ageless Global, LLC
			2722 S. West Temple, Salt Lake City, UT 84115
			agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs03/01/2021
			“MD CVK-365 Mouth Spray”
			Ageless Global, LLC
			2722 S. West Temple, Salt Lake City, UT 84115
			agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs02/26/2021
			Vy & Tea
			Qikmoov, LLC
			n/a
			vyteaus.com
			Undeclared sibutramine
			Public Notification
			Drugs02/26/2021
			“LUNGENE [sic]SARS-CoV-V-2 Covid-19 IgG/IgM Rapid Antibody Test Cassette to Detect Previous Corona Virus Infections”
			Orvic dba Webstore-USA
			15922 Strathern St #16, Van Nuys, CA 91406
			facemaskandppestore.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices02/24/2021
			Alpha Male Plus (also referred to as Alpha Male+)
			Various Distributors
			n/a
			alphamaleplus.us
			Undelclared tadalafil
			Public Notification
			Drugs02/18/2021
			MindSoothe Drops
			Native Remedies dba Silver Star Brands
			250 City Center, Oshkosh, WI 54906
			nativeremedies.com
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			MindSoothe Capsules
			Native Remedies dba Silver Star Brands
			250 City Center, Oshkosh, WI 54906
			nativeremedies.com
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			Mood Support
			Mountain Peak Nutritionals
			9953 SW Arctic Dr., Beaverton, OR 97005
			mountainpeaknutritionals.com
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			Natural Anxiety & Depression Relief
			Wholesome Wellness
			6804 NE 79th Court, Portland, OR 97218
			wholesome-wellness.com
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			Mood Boosting Probiotic
			Lifted Naturals
			1101 Mulberry St, A2 Suite 10, Kansas City, MO 64101
			liftednaturals.com
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			“Enlifta Mood Elevator”
			Enlifta, LLC
			16372 Page St., Omaha, NE 68118
			enlifta.com; amazon.com/Doctor-Designed-Depression-Enlifta-Supplement/dp/B00STR2MLQ/
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			“Enlifta Anxiety”
			Enlifta, LLC
			16372 Page St., Omaha, NE 68118
			enlifta.com; amazon.com/Doctor-Designed-Depression-Enlifta-Supplement/dp/B00STR2MLQ/
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			St. John’s Wort
			Blossom Nature, LLC
			1193 Elederberry Circle, Folsom, CA 95630
			blossom-nature.com; amazon.com/Supplement-National-Antidepressant-Support-Provides-Relief-120/dp/B082TTLJGP
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			Full SpectrumTM St. John's Wort Extract
			ProHealth Inc.
			555 Maple St, Carpinteria, CA 93013
			prohealth.com
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			Dr. Garber's Depression Relief
			Dr. Garber’s Natural Solutions
			2607 2nd St #1, Santa Monica, CA 90405
			drgarbers.com
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			Inositol 100% Pure Free Form
			FDC Nutrition Inc.
			2313 East Philadelphia Street Ste L, Ontario, CA
			fdcnutrition.com
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			Sleep Sana “Sleep Drops”
			SANA Group LLC
			1200 E. Woodhurst S-200, Springfield, MO 65804
			sleepsana.com
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			Sleep Sana “Sleep Shots”
			SANA Group LLC
			1200 E. Woodhurst S-200, Springfield, MO 65804
			sleepsana.com
			New Drug/Misbranded
			Warning Letter
			Foods
			News Release02/18/2021
			“Liposomal Vitamin C”
			Mercola.com, LLC
			125 SW 3rd Place, Suite 205, Cape Coral, FL 33991
			mercola.com; mercolamarket.com; twitter.com/mercola
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods02/18/2021
			“Liposomal Vitamin D3”
			Mercola.com, LLC
			125 SW 3rd Place, Suite 205, Cape Coral, FL 33991
			mercola.com; mercolamarket.com; twitter.com/mercola
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods02/18/2021
			“Quercetin and Pterostilbene Advanced”
			Mercola.com, LLC
			125 SW 3rd Place, Suite 205, Cape Coral, FL 33991
			mercola.com; mercolamarket.com; twitter.com/mercola
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods02/18/2021
			Earth Tea Extra Strength
			B4B Corp.
			40 Remsen Ave, Brooklyn, NY 11212
			b4bcorp.com; twitter.com/b4bcorpusa
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods02/18/2021
			The Prevention 12 Pak (Coronavirus Prevention 12 Pak), consists of the products SOUL, CORE, Cellular Detox, Turb-O2, Vitamin C (Anti-Oxidant Assist), Vitamin D3 (Light Assist), Glutathione, Selenium, Zinc, Vitamin A, Melatonin, and Iod Assist (Iodine)
			SafaLab, Inc.
			317 Cascade Ave., Langley, WA 98260
			safalab.com; weeksmd.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods02/16/2021
			“COVID-Aid Tincture”
			Dr. Paul's Lab
			9559 County Road Y, Mazomanie, WI 53560
			drpaulslab.net; drsarahsessentials.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs02/11/2021
			“BioCBD+ Total Body Care”
			Evolved Ayurvedic Discoveries, Inc./BioCBDPlus
			315 S. Coast Highway 101 Suite U75, Encinitas, CA 92024
			biocbdplus.com; facebook.com/BioCBDPlus; instagram.com/bio_cbd_plus
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs02/11/2021
			“BioCBD+ Topical Oil Muscle & Joint Support”
			Evolved Ayurvedic Discoveries, Inc./BioCBDPlus
			315 S. Coast Highway 101 Suite U75, Encinitas, CA 92024
			biocbdplus.com; facebook.com/BioCBDPlus; instagram.com/bio_cbd_plus
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs02/11/2021
			“BioCBD+ Peace Vape”
			Evolved Ayurvedic Discoveries, Inc./BioCBDPlus
			315 S. Coast Highway 101 Suite U75, Encinitas, CA 92024
			biocbdplus.com; facebook.com/BioCBDPlus; instagram.com/bio_cbd_plus
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs02/02/2021
			“OsteoBLAST®”
			Clarke Pharmaceutical Manufacturing, Inc.
			17448 Highway 3 Ste. 141, Webster, TX 77598
			clarkepharmaceuticals.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Drugs02/02/2021
			“Cell Block #19”
			Clarke Pharmaceutical Manufacturing, Inc.
			17448 Highway 3 Ste. 141, Webster, TX 77598
			clarkepharmaceuticals.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Drugs02/02/2021
			“High Potency Vitamin D3”
			Clarke Pharmaceutical Manufacturing, Inc.
			17448 Highway 3 Ste. 141, Webster, TX 77598
			clarkepharmaceuticals.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Drugs02/02/2021
			“Neupanex®”
			Clarke Pharmaceutical Manufacturing, Inc.
			17448 Highway 3 Ste. 141, Webster, TX 77598
			clarkepharmaceuticals.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Drugs02/02/2021
			“Natural Progesterone Skin Cream”
			Clarke Pharmaceutical Manufacturing, Inc.
			17448 Highway 3 Ste. 141, Webster, TX 77598
			clarkepharmaceuticals.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Drugs01/25/2021
			“COVID-19 BLOOD SPOT COLLECTION PACKET”
			EnMed MicroAnalytics, Inc.
			645 Meeting St, Suite 2, Charleston, SC 29403-4279
			enmedmicroanalytics.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices01/25/2021
			“SARS-CoV-2 SALIVA RT-PCR TEST COLLECTION PACKET"
			EnMed MicroAnalytics, Inc.
			645 Meeting St, Suite 2, Charleston, SC 29403-4279
			enmedmicroanalytics.com
			Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Devices01/22/2021
			AloeCure VeraFlex
			American Global Health Group, LLC
			11808 Northup Way, Suite W105, Bellevue, WA 98005
			aloecure.com; facebook.com/aloecure
			New Drug/Misbranded
			Warning Letter
			Foods01/22/2021
			AloeCure Advanced Formula Capsule
			American Global Health Group, LLC
			11808 Northup Way, Suite W105, Bellevue, WA 98005
			aloecure.com; facebook.com/aloecure
			New Drug/Misbranded
			Warning Letter
			Foods01/22/2021
			AloeCure Pure Aloe Vera Extract
			American Global Health Group, LLC
			11808 Northup Way, Suite W105, Bellevue, WA 98005
			aloecure.com; facebook.com/aloecure
			New Drug/Misbranded
			Warning Letter
			Foods01/22/2021
			AloeCure Probiotic + Enzyme
			American Global Health Group, LLC
			11808 Northup Way, Suite W105, Bellevue, WA 98005
			aloecure.com; facebook.com/aloecure
			New Drug/Misbranded
			Warning Letter
			Foods01/19/2021
			Adam’s Secret Extra Strength 1500
			Various Distributors
			n/a
			adamssecret.co; walmart.com
			Undeclared tadalafil and sildenafil
			Public Notification
			Drugs
			Recall01/19/2021
			Adam’s Secret Extra Strength 3000 Platinum
			Various Distributors
			n/a
			adamssecret.co
			Undeclared tadalafil and sildenafil
			Public Notification
			Drugs
			Recall01/14/2021
			“Golden Milk Electuary-Mushroom Cocoa Blend”
			Sage Moon Apothecary LLC
			40 Main Street, Seal Harbor, ME 04675
			sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaine
			New Drug/Misbranded
			Warning Letter
			Foods
			Closeout Letter01/14/2021
			“Golden Milk Electuary”
			Sage Moon Apothecary LLC
			40 Main Street, Seal Harbor, ME 04675
			sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaine
			New Drug/Misbranded
			Warning Letter
			Foods
			Closeout Letter01/14/2021
			“Beyond Elderberry Syrup”
			Sage Moon Apothecary LLC
			40 Main Street, Seal Harbor, ME 04675
			sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaine
			New Drug/Misbranded
			Warning Letter
			Foods
			Closeout Letter01/12/2021
			Allicin capsules, creams, gels, sprays, and liquidproducts
			Allimax Us
			500 W Superior St Unit 2205, Chicago, IL 60654
			allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods01/12/2021
			“Corona Destroyer Tea”
			AusarHerbs
			201 S. D Street, Madera, CA 93639
			ausarherbs.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods01/06/2021
			Lion's Mane -All Natural Supplement
			Entia Biosciences, Inc
			13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140
			totalnutraceutical.com
			New Drug/Misbranded
			Warning Letter
			Foods01/06/2021
			Antrodia Mushroom Powder
			Entia Biosciences, Inc
			13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140
			totalnutraceutical.com
			New Drug/Misbranded
			Warning Letter
			Foods01/06/2021
			Maitake Mushroom Powder
			Entia Biosciences, Inc
			13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140
			totalnutraceutical.com
			New Drug/Misbranded
			Warning Letter
			Foods01/06/2021
			Reishi Mushroom Powder
			Entia Biosciences, Inc
			13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140
			totalnutraceutical.com
			New Drug/Misbranded
			Warning Letter
			Foods01/06/2021
			Cordyceps Mushroom Powder
			Entia Biosciences, Inc
			13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140
			totalnutraceutical.com
			New Drug/Misbranded
			Warning Letter
			Foods01/06/2021
			Cordyceps - All Natural Mushroom Dietary Supplement
			Entia Biosciences, Inc
			13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140
			totalnutraceutical.com
			New Drug/Misbranded
			Warning Letter
			Foods01/04/2021
			4-Thieves Florida Tea Concentrate
			Coco's Holistic Specialties & Apothecary
			n/a
			cocosholisticspecialties.org/; facebook.com/KaliLengua; twitter.com/CocoEtsy
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs01/04/2021
			4-Thieves Florida Tea Powder
			Coco's Holistic Specialties & Apothecary
			n/a
			cocosholisticspecialties.org/; facebook.com/KaliLengua; twitter.com/CocoEtsy
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs12/28/2020
			Smarter Curcumin
			Smarter Nutrition, Inc.
			17870 Newhope St. Suite 104-480, Fountain Valley, CA 92708
			smarternutrition.com; facebook.com/smarternutrition1
			New Drug/Misbranded
			Warning Letter
			Foods12/28/2020
			Smarter Ubiquinol
			Smarter Nutrition, Inc.
			17870 Newhope St. Suite 104-480, Fountain Valley, CA 92708
			smarternutrition.com; facebook.com/smarternutrition1
			New Drug/Misbranded
			Warning Letter
			Foods12/28/2020
			Smarter Vitamin D3
			Smarter Nutrition, Inc.
			17870 Newhope St. Suite 104-480, Fountain Valley, CA 92708
			smarternutrition.com; facebook.com/smarternutrition1
			New Drug/Misbranded
			Warning Letter
			Foods12/22/2020
			Synotrex
			Speedwinds Nutrition, Inc.
			818 SW 3rd Avenue, Portland, OR 97204
			speedwindsnutrition.com; synotrex.com; amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods12/22/2020
			Sephren
			Speedwinds Nutrition, Inc.
			818 SW 3rd Avenue, Portland, OR 97204
			speedwindsnutrition.com; synotrex.com; amazon.com
			New Drug/Misbranded
			Warning Letter
			Foods12/22/2020
			RHINODOL CBD” nasal spray products
			New Leaf Pharmaceuticals, LLC
			77 South Main Street, Newton, CT 06470
			newleafpharma.com; facebook/CBDMedicalProducts/
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded
			Warning Letter
			Drugs12/22/2020
			Various human and animal products, promoted to contain cannabidiol (CBD)
			NextL3vel Services Group, LLC dba This Stuff Is Good For You
			3400 W. Desert Inn Rd. Suite 2, Las Vegas, NV 89102
			thisstuffisgoodforyou.com; facebook.com/tsigfy; instagram.com/tsigfy
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs; Animal & Veterinary12/22/2020
			“WBRx Metered-Dose Inhaler"
			Wellness BioSciences Rx
			9789 Katy Freeway #1801, Houston, TX 77024
			wbrxglobal.com; twitter.com/wellnessbiosrx
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs12/22/2020
			"WBRx Balance Softgels CBD”
			Wellness BioSciences Rx
			9789 Katy Freeway #1801, Houston, TX 77024
			wbrxglobal.com; twitter.com/wellnessbiosrx
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs12/22/2020
			“WBRx Pure Wellness CBD” (“WBRx Combo Pack”)
			Wellness BioSciences Rx
			9789 Katy Freeway #1801, Houston, TX 77024
			wbrxglobal.com; twitter.com/wellnessbiosrx
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs12/22/2020
			“WBRx Energy Oil Drops CBD”
			Wellness BioSciences Rx
			9789 Katy Freeway #1801, Houston, TX 77024
			wbrxglobal.com; twitter.com/wellnessbiosrx
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs12/22/2020
			“WBRx Relief Balm CBD”
			Wellness BioSciences Rx
			9789 Katy Freeway #1801, Houston, TX 77024
			wbrxglobal.com; twitter.com/wellnessbiosrx
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs12/22/2020
			“WBRx Sleep Oil Drops CBD
			Wellness BioSciences Rx
			9789 Katy Freeway #1801, Houston, TX 77024
			wbrxglobal.com; twitter.com/wellnessbiosrx
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
			Warning Letter
			Drugs12/22/2020
			“Canna Bees Rescue Blend”
			Bee Delightful
			n/a
			beedelightful.com; facebook.com/BeeDelightfulUSA
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods12/21/2020
			“C BETTER DAILY Adult Regular Formula”
			G & L Wellness, LLC
			2231 14th St S 114, Wisconsin Rapids, WI 54494
			glwellness.net
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded
			Warning Letter
			Drugs; Animal & Veterinary12/21/2020
			“C BETTER DAILY Adult Maximum Formula”
			G & L Wellness, LLC
			2231 14th St S 114, Wisconsin Rapids, WI 54494
			glwellness.net
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded
			Warning Letter
			Drugs; Animal & Veterinary12/21/2020
			“C BETTER DAILY Soothing Formula”
			G & L Wellness, LLC
			2231 14th St S 114, Wisconsin Rapids, WI 54494
			glwellness.net
			Finished Pharmaceuticals/Unapproved New Drug/Misbranded
			Warning Letter
			Drugs; Animal & Veterinary12/21/2020
			“Flu Immune Drops”
			Riverstone LLC
			51668 Blue River Dr, Blue River, OR 97413
			doctorschoice.org
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods12/21/2020
			“L-Lysine”
			Riverstone LLC
			51668 Blue River Dr, Blue River, OR 97413
			doctorschoice.org
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods12/21/2020
			“Lysine Extra”
			Riverstone LLC
			51668 Blue River Dr, Blue River, OR 97413
			doctorschoice.org
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods12/21/2020
			“Monolaurin”
			Riverstone LLC
			51668 Blue River Dr, Blue River, OR 97413
			doctorschoice.org
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods12/21/2020
			Organic Liposomal Vitamin C
			Sparrow Health & Performance LLC
			2000 Southlake Park Suite 150, Hoover, AL 35244
			sparrowclinic.com; facebook.com/sparrowclinic; instagram.com/sparrowclinic/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods12/21/2020
			Nanoemulsified D3K2 (also referred to as “Liquid Liposomal Vitamin D3 with K2” or “Liposomal Vitamin D3”
			Sparrow Health & Performance LLC
			2000 Southlake Park Suite 150, Hoover, AL 35244
			sparrowclinic.com; facebook.com/sparrowclinic; instagram.com/sparrowclinic/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods12/21/2020
			Immune Support Package (which includes your Organic Liposomal Vitamin C, Nanoemulsified D3K2, and Virus Be Gone products, with Smart Silver as an optional add-on)
			Sparrow Health & Performance LLC
			2000 Southlake Park Suite 150, Hoover, AL 35244
			sparrowclinic.com; facebook.com/sparrowclinic; instagram.com/sparrowclinic/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods12/18/2020
			“Glycostasis,”
			Reddy Naturals
			1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
			reddynaturals.com; facebook.com/ReddyNaturals
			New Drug/Misbranded
			Warning Letter
			Drugs12/18/2020
			“Glucosamine Curcumin”
			Reddy Naturals
			1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
			reddynaturals.com; facebook.com/ReddyNaturals
			New Drug/Misbranded
			Warning Letter
			Drugs12/18/2020
			“Turmeric 50”
			Reddy Naturals
			1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
			reddynaturals.com; facebook.com/ReddyNaturals
			New Drug/Misbranded
			Warning Letter
			Drugs12/18/2020
			“Turmeric Curcumin”
			Reddy Naturals
			1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
			reddynaturals.com; facebook.com/ReddyNaturals
			New Drug/Misbranded
			Warning Letter
			Drugs12/18/2020
			“Cetyl Curcumin”
			Reddy Naturals
			1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
			reddynaturals.com; facebook.com/ReddyNaturals
			New Drug/Misbranded
			Warning Letter
			Drugs12/18/2020
			“Ashwagandha”
			Reddy Naturals
			1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
			reddynaturals.com; facebook.com/ReddyNaturals
			New Drug/Misbranded
			Warning Letter
			Drugs12/18/2020
			“Huruli”
			Reddy Naturals
			1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
			reddynaturals.com; facebook.com/ReddyNaturals
			New Drug/Misbranded
			Warning Letter
			Drugs12/18/2020
			“Black Seed Oil”
			Reddy Naturals
			1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
			reddynaturals.com; facebook.com/ReddyNaturals
			New Drug/Misbranded
			Warning Letter
			Drugs12/18/2020
			“Curcumin Turmerone”
			Reddy Naturals
			1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
			reddynaturals.com; facebook.com/ReddyNaturals
			New Drug/Misbranded
			Warning Letter
			Drugs12/18/2020
			“Ashwagandha Honey”
			Reddy Naturals
			1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
			reddynaturals.com; facebook.com/ReddyNaturals
			New Drug/Misbranded
			Warning Letter
			Drugs12/18/2020
			CloSYS Oral Spray
			Rowpar Pharmaceuticals
			16100 N. Greenway Hayden Loop #400, Scottsdale, AZ 85260
			closys.com; facebook.com/ClosSYS; twitter.com/closys
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs12/18/2020
			CloSYS Non-Irritating RINSE UN-flavored for ULTRA SENSITIVE Mouths
			Rowpar Pharmaceuticals
			16100 N. Greenway Hayden Loop #400, Scottsdale, AZ 85260
			closys.com; facebook.com/ClosSYS; twitter.com/closys
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs12/18/2020
			CloSYS Non-Irritating RINSE Mildly Flavored for SENSITIVE Mouths
			Rowpar Pharmaceuticals
			16100 N. Greenway Hayden Loop #400, Scottsdale, AZ 85260
			closys.com; facebook.com/ClosSYS; twitter.com/closys
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs12/17/2020
			Triple SupremeZen Plus 3500
			Various Distributors; Recall by Yolo Studio/Hyobin LLC
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release

			Untitled Letter12/17/2020
			Shogun-X Black
			Various Distributors; Recall by Ummzy LLC/Knabe Inc
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Triple SupremeZen Extreme 3500
			Various Distributors; including seller Otwo
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Untitled Letter12/17/2020
			Thumbs Up 7 White 11K
			Various Distributors; Recall by Nuri Trading LLC
			n/a
			amazon.com
			Undeclared sildenafil, tadalafil and vardenafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Thumbs Up 7 Red 70K
			Various Distributors; Recalls by Antoto-K and Ummzy LLC/Knabe Inc
			n/a
			amazon.com
			Undeclared sildenafil, tadalafil and vardenafil
			Public Notification
			Drugs
			News Release

			Recall (Antoto-K); Recall (Ummzy LLC/Knabe Inc)

			Untitled Letter12/17/2020
			Thumbs Up 7 Blue 69K
			Various Distributors; Recall by Bit & Bet LLC
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Thumbs Up 7 Black 25K
			Various Distributors; Recall by Nuri Trading LLC
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Rock Steady 72 Hours
			Various Distributors; including seller Rock Steady 72 Hours
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Untitled Letter12/17/2020
			Red Spartan 3000
			Various Distributors; including seller Amazon.com
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Untitled Letter12/17/2020
			Premium OrgaZen 7000
			Various Distributors; Recall by 
			NS NY Distributor Inc
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Premier Platinum 5000 (PremierZEN Platinum 5000)
			Various Distributors; Recall by NANA Collection LLC/E-Factory NY
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			PremierZen Extreme 3000
			Various Distributors; Recalls by QMART and Yolo Studio
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release

			Recall (QMART); Recall (Yolo Studio)

			Untitled Letter12/17/2020
			PremierZen Black 5000
			Various Distributors; Recall by Namoo Enterprise LLC/All-R0under
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Original White Dragon
			Various Distributors; including seller A&D Health
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Untitled Letter12/17/2020
			Krazy Night
			Various Distributors; Recall by Ummzy LLC/Knabe Inc
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Kopi Jantan Tradisional Natural Herbs Coffee
			Various Distributors; including seller smile_elephant
			n/a
			amazon.com
			Undeclared sildenafil
			Public Notification
			Drugs
			News Release

			Untitled Letter12/17/2020
			Imperial Platinum 2000
			Various Distributors; Recall by QMART
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Imperial Gold 2000
			Various Distributors; Recall by QMART
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Imperial Extreme 2000
			Various Distributors; Recall by S&B Shopper LLC
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Hot Rod
			Various Distributors; including BZ USA LLC/BZ USA LLC
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release

			Untitled Letter12/17/2020
			Ginseng Power 5000
			Various Distributors; Recall by 
			NS NY Distributor Inc
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Burro en Primavera 60000
			Various Distributors; Recall by QMART
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			69MODE Blue 69
			Various Distributors; Recall by Nuri Trading LLC
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			3 KO Gold XT
			Various Distributors; including seller Vitality Mate
			n/a
			amazon.com
			Undeclared vardenafil
			Public Notification
			Drugs
			News Release

			Untitled Letter12/17/2020
			Shogun-X Platinum 7000
			Various Distributors; Recall by Nuri Trading LLC
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Triple SupremeZen Gold 3500
			Various Distributors; Recall by NANA Collection LLC/E-Factory NY
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Recall

			Untitled Letter12/17/2020
			Burn 7
			Various Distributors; including seller befitaholic
			n/a
			ebay.com
			Undeclared phenolphthalein
			Public Notification
			Drugs
			News Release12/17/2020
			Premier maxxzen Platinum 12000
			Various Distributors; including seller Miracle8989
			n/a
			ebay.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Recall12/17/2020
			Poseidon Platinum 10000
			Various Distributors; including seller co.america
			n/a
			ebay.com
			Undeclared vardenafil
			Public Notification
			Drugs
			News Release12/17/2020
			Poseidon Platinum 3500
			Various Distributors; including seller Yamtun7
			n/a
			ebay.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Recall12/17/2020
			Mero Macho
			Various Distributors; including seller setec24
			n/a
			ebay.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release12/17/2020
			Gold Lion
			Various Distributors; including seller unityhealth
			n/a
			ebay.com
			Undeclared sildenafil
			Public Notification
			Drugs
			News Release12/17/2020
			White Panther
			Various Distributors; including seller qualmart1-9
			n/a
			ebay.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release12/17/2020
			Triple Wicked Platinum
			Various Distributors; including seller pricemasters_usa
			n/a
			ebay.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release12/17/2020
			The Super Panther 77k
			Various Distributors; including seller qualmart1-9
			n/a
			ebay.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release12/17/2020
			Royal Honey
			Various Distributors; including seller ahmedjamilmuslim
			n/a
			ebay.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release12/17/2020
			PremierZen Gold 7000
			Various Distributors; Recall by Miracle8989
			n/a
			ebay.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Recall12/17/2020
			PremierZen Platinum 8000
			Various Distributors; Recall by Miracle8989
			n/a
			ebay.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release

			Recall12/17/2020
			Blue Panther Extreme 75k
			Various Distributors; including seller qualmart1-9
			n/a
			ebay.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs
			News Release12/17/2020
			Black Stallion 9000
			Various Distributors; including seller qualmart1-9
			n/a
			ebay.com
			Undeclared tadalafil
			Public Notification
			Drugs
			News Release12/17/2020
			Lishou Slimming Coffee
			Various Distributors; including seller annday14
			n/a
			ebay.com
			Undeclared sibutramine and desmethylsibutramine
			Public Notification
			Drugs
			News Release12/17/2020
			Li Da Daidaihua Plus
			Various Distributors; including seller micki_jay
			n/a
			ebay.com
			Undeclared phenolphthalein
			Public Notification
			Drugs
			News Release12/17/2020
			Imperla Elita Vitaccino
			Various Distributors; Recall by Dash Xclusive
			n/a
			ebay.com
			Undeclared sibutramine and fluoxetine
			Public Notification
			Drugs
			News Release

			Recall12/17/2020
			Fruta Planta
			Various Distributors; including seller aialoj0
			n/a
			ebay.com
			Undeclared sibutramine
			Public Notification
			Drugs
			News Release12/17/2020
			Fruta Bio
			Various Distributors; including seller frutabio
			n/a
			ebay.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs
			News Release12/17/2020
			Super Slim
			Various Distributors; including seller emmcli0
			n/a
			ebay.com
			Undeclared sibutramine and desmethylsibutramine
			Public Notification
			Drugs
			News Release12/15/2020
			“Oleander 4X”
			Phoenix Biotechnology, Inc.; Avila Herbals, LLC
			8626 Tesoro Dr., Suite 801, San Antonio, TX 78217

			4025 Childress Rd., Christiansburg, VA 24073
			phoenixbiotechnology.com; myoleander.com; avilaherbals.com; twitter.com/PhoenixBioInc
			Finished Pharmaceuticals/Unapproved new drug
			Warning Letter
			Drugs12/10/2020
			"Chest Tea”
			Prairie Dawn Herbs
			4250 S. Calhan Hwy Yoder, CO 80864-9669
			prairiedawnherbs.com
			Finished Pharmaceuticals/Unapproved new drug
			Warning Letter
			Foods12/10/2020
			“Ginger Oil”
			Prairie Dawn Herbs
			4250 S. Calhan Hwy Yoder, CO 80864-9669
			prairiedawnherbs.com
			Finished Pharmaceuticals/Unapproved new drug
			Warning Letter
			Foods12/10/2020
			“Dandelion root Tincture”
			Prairie Dawn Herbs
			4250 S. Calhan Hwy Yoder, CO 80864-9669
			prairiedawnherbs.com
			Finished Pharmaceuticals/Unapproved new drug
			Warning Letter
			Foods12/10/2020
			“Echinacea purpurea Tincture”
			Prairie Dawn Herbs
			4250 S. Calhan Hwy Yoder, CO 80864-9669
			prairiedawnherbs.com
			Finished Pharmaceuticals/Unapproved new drug
			Warning Letter
			Foods12/10/2020
			“Antispasmodic Tincture”
			Prairie Dawn Herbs
			4250 S. Calhan Hwy Yoder, CO 80864-9669
			prairiedawnherbs.com
			Finished Pharmaceuticals/Unapproved new drug
			Warning Letter
			Foods12/10/2020
			“Ginger Tincture”
			Prairie Dawn Herbs
			4250 S. Calhan Hwy Yoder, CO 80864-9669
			prairiedawnherbs.com
			Finished Pharmaceuticals/Unapproved new drug
			Warning Letter
			Foods12/10/2020
			“Cayenne Tincture”
			Prairie Dawn Herbs
			4250 S. Calhan Hwy Yoder, CO 80864-9669
			prairiedawnherbs.com
			Finished Pharmaceuticals/Unapproved new drug
			Warning Letter
			Foods12/10/2020
			Vitamins
			iThrive.health
			n/a
			ithrive.health;
			facebook.com/iTHRIVE.health/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs12/10/2020
			Quercetin products
			iThrive.health
			n/a
			ithrive.health;
			facebook.com/iTHRIVE.health/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs12/10/2020
			Zinc products
			iThrive.health
			n/a
			ithrive.health;
			facebook.com/iTHRIVE.health/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs12/10/2020
			Omega-3 products
			iThrive.health
			n/a
			ithrive.health;
			facebook.com/iTHRIVE.health/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs12/10/2020
			Mineral products
			Indigenous Products
			Dallas, TX 75232
			facebook.com/Indigenous-Products-106070747498475/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs12/09/2020
			Healthy-Thin Energize”
			Bodyhealth.com, LLC
			707 Cleveland St. Clearwater, FL 33755-4107
			bodyhealth.com
			New Drug/Misbranded
			Warning Letter
			Foods12/09/2020
			“Body Detox (Oral Spray)”
			Bodyhealth.com, LLC
			707 Cleveland St. Clearwater, FL 33755-4107
			bodyhealth.com
			New Drug/Misbranded
			Warning Letter
			Foods12/09/2020
			“Omega 3 Health”
			Bodyhealth.com, LLC
			707 Cleveland St. Clearwater, FL 33755-4107
			bodyhealth.com
			New Drug/Misbranded
			Warning Letter
			Foods12/07/2020
			“Thymosin Alpha 1”
			Paradigm RE LLC
			1511 N. Convent 700-156 Bourbonnais, IL 60914
			paradigmpeptides.com/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs12/04/2020
			Fortify
			Desert Alchemist LLC
			Tucson, AZ
			etsy.com/shop/DesertAlchemis;
			facebook.com/desertalchemist;
			instagram.com/desert
			New Drug/Misbranded
			Warning Letter
			Foods12/04/2020
			Lion's Mane
			Desert Alchemist LLC
			Tucson, AZ
			etsy.com/shop/DesertAlchemis;
			facebook.com/desertalchemist;
			instagram.com/desert
			New Drug/Misbranded
			Warning Letter
			Foods12/04/2020
			The Great Work
			Desert Alchemist LLC
			Tucson, AZ
			etsy.com/shop/DesertAlchemis;
			facebook.com/desertalchemist;
			instagram.com/desert
			New Drug/Misbranded
			Warning Letter
			Foods12/04/2020
			Mind Ease
			Desert Alchemist LLC
			Tucson, AZ
			etsy.com/shop/DesertAlchemis;
			facebook.com/desertalchemist;
			instagram.com/desert
			New Drug/Misbranded
			Warning Letter
			Foods12/04/2020
			Sweet Balance
			Desert Alchemist LLC
			Tucson, AZ
			etsy.com/shop/DesertAlchemis;
			facebook.com/desertalchemist;
			instagram.com/desert
			New Drug/Misbranded
			Warning Letter
			Foods12/04/2020
			Happy Heart
			Desert Alchemist LLC
			Tucson, AZ
			etsy.com/shop/DesertAlchemis;
			facebook.com/desertalchemist;
			instagram.com/desert
			New Drug/Misbranded
			Warning Letter
			Foods12/04/2020
			Flair Snare
			Desert Alchemist LLC
			Tucson, AZ
			etsy.com/shop/DesertAlchemis;
			facebook.com/desertalchemist;
			instagram.com/desert
			New Drug/Misbranded
			Warning Letter
			Foods12/04/2020
			Cordycepts sinensis double extract
			Desert Alchemist LLC
			Tucson, AZ
			etsy.com/shop/DesertAlchemis;
			facebook.com/desertalchemist;
			instagram.com/desert
			New Drug/Misbranded
			Warning Letter
			Foods12/02/2020
			“Evening Primrose Oil,”
			Smoky Mountain Naturals, LLC
			3605 Nebraska Avenue Nashville, TN 37209
			smnutrition.com
			New Drug/Misbranded
			Warning Letter
			Foods12/02/2020
			“Beta Glucan"
			Smoky Mountain Naturals, LLC
			3605 Nebraska Avenue Nashville, TN 37209
			smnutrition.com
			New Drug/Misbranded
			Warning Letter
			Foods12/02/2020
			C60 (Carbon 60), including “AVOCADO C60 ANTI-VIRAL COMBO – VIRUS PREVENTION”
			Heavenly Natural Products
			100 Monroe St #406 Centerton, AR 72719
			heavenlynaturalproducts.com;
			facebook.com/heavenlyc60;
			twitter.com/hnpC60;
			pinterest.com/heavenlynaturalproductsc/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods12/02/2020
			Colloidal silver, including "Heavenly Silver"
			Heavenly Natural Products
			100 Monroe St #406 Centerton, AR 72719
			heavenlynaturalproducts.com;
			facebook.com/heavenlyc60;
			twitter.com/hnpC60;
			pinterest.com/heavenlynaturalproductsc/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods12/02/2020
			“VIRUS BIOSHIELD”
			Rat's Army
			4126 US HWY 93 S Kalispell, MT 59901
			rats.army/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs12/02/2020
			"Dr. Hotze’s Immune Pak with Vitamins A, B, C, D, Zinc and Probiotics”
			Health & Wellness Center International One, L.L.C. dba Hotze Vitamins
			20214 Braidwood, Ste. 215 Katy, TX 77450
			hotzehwc.com;
			hotzevitamins.com;
			facebook.com/Hotze-HWC/;
			facebook.com/MyHotzeVitamins/
			twitter.com/hotzehealth.com;
			twitter.com/HotzeVitamins/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods12/02/2020
			“Dr. Hotze’s Kids Immune Pak”
			Health & Wellness Center International One, L.L.C. dba Hotze Vitamins
			20214 Braidwood, Ste. 215 Katy, TX 77450
			hotzehwc.com;
			hotzevitamins.com;
			facebook.com/Hotze-HWC/;
			facebook.com/MyHotzeVitamins/
			twitter.com/hotzehealth.com;
			twitter.com/HotzeVitamins/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods12/02/2020
			“Dr. Hotze’s Teen Immune Pak”
			Health & Wellness Center International One, L.L.C. dba Hotze Vitamins
			20214 Braidwood, Ste. 215 Katy, TX 77450
			hotzehwc.com;
			hotzevitamins.com;
			facebook.com/Hotze-HWC/;
			facebook.com/MyHotzeVitamins/
			twitter.com/hotzehealth.com;
			twitter.com/HotzeVitamins/
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods11/24/2020
			U.S.A. Viagra
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/24/2020
			Stree Overlord
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil and ciprofloxacin
			Public Notification
			Drugs11/24/2020
			Rhinozen 69 Platinum 75000
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/24/2020
			Rhino 99 Extreme 90000
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/24/2020
			Rhino 96 Platinum 77000
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/24/2020
			Rhino 69 Platinum 25000
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/24/2020
			Rhino 69 Power 500K
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/24/2020
			Rhino 8 Platinum 80000
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/24/2020
			Body Shape Weight Loss System
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sibutramine
			Public Notification
			Drugs11/24/2020
			Bigger Longer More Time More Sperms (sic)
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/24/2020
			Herb Viagra Male Sexual Stimulant
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/24/2020
			Magnum XXL 50K
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/24/2020
			Magnum XXL 9800
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/24/2020
			V8 Super Energy
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/18/2020
			Vigorous Man
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/18/2020
			Livtone
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and fluoxetine
			Public Notification
			Drugs09/01/2020
			Red-E
			The Protein Shoppe, LLC
			101 E Exp. 83 Ste. A-1 Pharr, TX 78557
			The Protein Shoppe, LLC
			Undeclared sildenafil
			Recall
			Drugs07/09/2020
			Tenadam Herb
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Spiced Tea
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Nigerian Moringa Leaf Powder
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Jamaican Turmeric
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Bitter Wood
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Devil Horsewhip
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Mango Leaf
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Red Water Grass
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Sarsaparilla
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Marsh Marigold
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Sea Moss/Irish Moss
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Dog Blood
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Guava Leaf
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Jack in the Bush
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			King of the Forest
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			ETHIOPIAN ABISH (FENNUGREEK SEED PWD.)
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Ethiopian Traditional Talba (Flaxseed Meal Cereal)
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Fever Grass
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Jamaican Milk Wiss
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Spanish Needle
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Fig Leaf
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Diabetics
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Flax Seed Oil & Honey Blend
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Bitter Kola (Arogbo)
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Jamaican Bissy Powder
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Ghanian Black Spice
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Piss A Bed
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			White Pond Lily
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Purple Sage
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Quassia Wood
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Trumpet Leaf
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			White Jointa
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			White Sage
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Guinea Hen Weed
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Sundial Cassava Meal
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Cocoa Balls
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			African Fever Bush
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Mojo Bush
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Blood Leaf
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Wood & Root Tonic
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Koromantee
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Ashanti
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			African Manback Tonic
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Pimento
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Mitmitta (Cayenne Pepper)
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Mahogany Bark
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Chaney Root
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Cerasee Bay Leaves, Mango Bark
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Asthma
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Blood Pressure
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Heart
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Worms and Parasites
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Flu-Allergies /HayFever
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Arthritis
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Axum Traditional Ethiopian Honey Beverage
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Black Sage
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Black Wiss
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Cinnamon
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Palo De Brazil
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Broom Weed
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Bread Nut
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Jamaican and Tropical Raw Honey
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Hemp Seed Oil
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Talibah’s Tooth Powder and Ethiopian Coffee
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods07/09/2020
			Blue Vervain
			Sundial Herbal Products
			3609 Boston Road, Bronx, NY
			sundialherbs.com/sundial
			Misbranding & Unapproved New Drugs
			Recall
			Foods05/20/2020
			Sterile Cannabidiol (CBD) previously listed as Cannabidiol (CBD) Complex
			Biota Biosciences, LLC
			Seattle, WA
			n/a
			Unapproved new drug; injectable products marketed without FDA approval
			Recall
			Drugs05/20/2020
			Sterile Curcumin previously listed as Curcumin Complex 4 10 mL
			Biota Biosciences, LLC
			Seattle, WA
			n/a
			Unapproved new drug; injectable products marketed without FDA approval
			Recall
			Drugs05/20/2020
			Sterile Cannabidiol (CBD) + Curcumin previously listed as Cannabidiol (CBD) + Curcumin Complex
			Biota Biosciences, LLC
			Seattle, WA
			n/a
			Unapproved new drug; injectable products marketed without FDA approval
			Recall
			Drugs05/19/2020
			Dr. Rima RecommendsTM Nano Silver 10 PPM
			Natural Solutions Foundation
			58 Plotts Rd, Newton NJ 07860
			drrimatruthreports.com; opensourcetruth.com; truthaboutcoronavirus.com; nsfmarketplace.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Foods
			Recall05/11/2020
			“CORE”
			Fusion Health and Vitality LLC
			1360 Union Hill Road Suite 11B, Alpharetta, GA 30004
			pharmorigins.com; freecoreoffer.online; immune-shot.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs
			Recall05/11/2020
			“IMMUNE SHOT”
			Fusion Health and Vitality LLC
			1360 Union Hill Road Suite 11B, Alpharetta, GA 30004
			pharmorigins.com; freecoreoffer.online; immune-shot.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs
			Recall05/06/2020
			NAD+ Sublingual Gel
			Alive By Nature, Inc.
			2574 Whispering Pines Dr.
			Fleming Island, FL 32003
			alivebynature.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs05/06/2020
			NMN Sublingual Gel
			Alive By Nature, Inc.
			2574 Whispering Pines Dr.
			Fleming Island, FL 32003
			alivebynature.com
			Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
			Warning Letter
			Drugs04/22/2020
			Black Mamba Premium 18000
			Bandera Ice House
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs03/16/2020
			Active Male
			Natural Remedy Store
			San Antonio, TX
			Natural Remedy Store
			Undeclared tadalafil
			Recall
			Drugs02/24/2020
			Bow & Arrow
			Med Man Distribution
			n/a
			Distributed in the USA to Regal Labs and to their nationwide retailers
			Undeclared sildenafil
			Recall
			Drugs02/05/2020
			XXX Platinum WOODIE
			Various Distributors
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs02/05/2020
			Alpha-Male
			Various Distributors
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs02/05/2020
			RMFLEX
			Various Distributors
			n/a
			ebay.com
			Undeclared diclofenac
			Public Notification
			Drugs02/05/2020
			OrgaZEN Gold 5800
			Various Distributors
			n/a
			amazon.com
			Undeclared sildenafil
			Public Notification
			Drugs12/18/2019
			U-Dream Lite
			Various Distributors
			n/a
			amazon.com
			Undeclared eszopiclone and zopiclone
			Public Notification
			Drugs12/18/2019
			U-Dream Full Night
			Various Distributors
			n/a
			amazon.com
			Undeclared eszopiclone and zopiclone
			Public Notification
			Drugs12/17/2019
			SUPER Platinum 30000 RHINO 7
			Motto International Corp.
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs12/17/2019
			SUPER Platinum 30000 PANTHER
			Motto International Corp.
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs12/17/2019
			SUPER Platinum 30000 STALLION
			Motto International Corp.
			n/a
			n/a
			Undeclared sildenafil, tadalafil, and dapoxetine
			Public Notification
			Drugs12/17/2019
			SUPER Platinum 30000 BULL
			Motto International Corp.
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs12/13/2019
			PremierZEN Gold 7000
			Various Distributors
			n/a
			voltcandyonline.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs12/09/2019
			Essential Oils, including Bergamot bergaptene free (Citrus bergamia), Listea Cubea, Cypress – Cupressus sempervirens, Cinnamon Leaf – Cinnamomum zeylanicum, Chamomile Roman – Anthemis nobilis, and Carrot Seed – Daucus carota
			Kelley Pure Essentials Oils
			404 W. 5th St.
			New Richmond, WI 54017
			kelleypureessentialoils.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/09/2019
			Herbal Detox Pearls
			Coochie Couture
			P.O. Box 251
			Selden, NY 11784
			coochiecouture.net/;
			instagram.com/coochiecouture_/;
			facebook.com/coochiecouturee
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/09/2019
			Blood Sugar Ultra
			Blood Sugar Ultra
			1140 S. Highbrook Street
			Suite 400
			Akron, OH 44301
			healthtech24.net/diabetes-report; bloodsugarultra.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/09/2019
			SNAP Capsule Formula
			Simply Natural Advanced Pharma (SNAP)
			n/a
			adhdsnap.com;
			facebook.com/SNAPtoday/;
			instagram.com/snap4health/;
			twitter.com/SNAP4ADHD
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/09/2019
			SNAP Liquid Formula
			Simply Natural Advanced Pharma (SNAP)
			n/a
			adhdsnap.com;
			facebook.com/SNAPtoday/;
			instagram.com/snap4health/;
			twitter.com/SNAP4ADHD
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/04/2019
			Detox Plus
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared tadalafil, paynantheine, and mitragynine
			Public Notification
			Drugs11/14/2019
			Power Khan
			Various Distributors
			n/a
			powerkhanusa.com
			Undeclared desmethyl thiosildenafil, thioaildenafil, and aildenafil
			Public Notification
			Drugs11/13/2019
			Man Erect
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/13/2019
			SHENGDA
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs10/24/2019
			CholesLo
			HFL Solutions LLC
			13077 Bluff Creek Dr., Playa Vista, CA 90094
			choleslo.com
			Undeclared lovastatin
			Public Notification
			Drugs
			Warning Letter10/17/2019
			Skinny Pill
			Lose Fat Gain Life M&B
			4102 Orange Ave Ste 118 & 119, Long Beach, CA 90807
			losefatgainlifemb.com
			Undeclared 1,3-dimethylamylamine (DMAA)
			Public Notification
			Foods
			Warning Letter10/16/2019
			UP2
			Various Distributors
			n/a
			hmherbs.com
			Undeclared sildenafil
			Public Notification
			Drugs
			Recall10/09/2019
			CHU
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs09/26/2019
			Kim Whitening Pearl and Snowlotus Cream
			Kim Co, LTD
			888/32 Bang Pree Industrial Estate , Samut Prakan, Samut Prakan Thailand
			n/a
			Found to contain 0.047 g/kg of mercury
			Alert
			Drugs
			Import Alert 53-1809/26/2019
			Golden Pearl Beauty Cream
			Golden Pearl Cosmetics
			115/1 M , Quaid-e-Azam Industrial Estate , Kot Lakhpat, Lahore, Punjab Pakistan
			n/a
			Found to contain 12 g/kg of mercury
			Alert
			Drugs
			Import Alert 53-1809/26/2019
			Chandni Whitening Cream
			SJ Enterprises
			222 CCA FF , DHA Phase 4 Sector CCA , Lahore, Punjab Pakistan
			n/a
			Found to contain 8.79 g/kg of mercury
			Alert
			Drugs
			Import Alert 53-1809/26/2019
			Goree Beauty Cream
			Goree Cosmetics
			n/a
			n/a
			Found to contain 17.2 g/kg of mercury
			Alert
			Drugs09/26/2019
			Sandal Whitening Beauty Cream
			MMC Cosmetics Pakistan
			Main Bazar Rd , Karbirwala, Khanewal Pakistan
			n/a
			Found to contain 13.1 g/kg of mercury
			Alert
			Drugs
			Import Alert 53-1809/26/2019
			Monespa Express Peeling
			Various Distributors
			n/a
			n/a
			Found to contain 5.03 g/kg of mercury
			Alert
			Drugs09/26/2019
			Face Fresh Beauty Cream
			Shaheen Costmetics PVT LTD
			House #8, Block-A4 , P.G.E.C.M.S Punjab Society , Lahore, Punjab Pakistan
			n/a
			Found to contain 18.5 g/kg of mercury
			Alert
			Drugs
			Import Alert 53-1809/19/2019
			Green Lumbar
			GL Holdings
			Newport Beach, California
			getgreenlumber.com; greenlumber.com
			Undeclared tadalafil
			Public Notification
			Drugs
			Recall09/16/2019
			Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement
			Fitoterapia USA Inc.
			n/a
			fitoterapiausa.com
			Undeclared tadalafil
			Recall
			Drugs09/09/2019
			Anaconda Strong Formula
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs09/09/2019
			La Pepa Negra
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs09/09/2019
			Lung Leader
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs09/06/2019
			Lanugar
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and N-desmethylsibutramine
			Public Notification
			Drugs09/06/2019
			JaDera PLUS
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine, N-desmethylsibutramine, and benproperine
			Public Notification
			Drugs09/06/2019
			Sheaya Lender
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and fluoxetine
			Public Notification
			Drugs09/06/2019
			Love in S
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and N-desmethylsibutramine
			Public Notification
			Drugs09/06/2019
			LOBO
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs09/06/2019
			Mero Macho
			Various Distributors
			n/a
			fitoterapiausa.com; meromachodrink.com
			Undeclared tadalafil
			Public Notification
			Drugs07/25/2019
			Chrysanthemum/Hibiscus Blend Tea
			Moyeam USA TEA, LLC
			n/a
			pureamitea.com; getmoyeam.com
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Eagle Tea
			Moyeam USA TEA, LLC
			n/a
			pureamitea.com; getmoyeam.com
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Qing Yun Moyeam Tea
			Moyeam USA TEA, LLC
			n/a
			pureamitea.com; getmoyeam.com
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			NAD+/H2S Energizer
			Alive By Nature, Inc.
			2574 Whispering Pines Dr.
			Fleming Island, FL 32003
			alivebynature.com
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			NAD+ Defender
			Alive By Nature, Inc.
			2574 Whispering Pines Dr.
			Fleming Island, FL 32003
			alivebynature.com
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Pure NAD+ Sublingual tablets
			Alive By Nature, Inc.
			2574 Whispering Pines Dr.
			Fleming Island, FL 32003
			alivebynature.com
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Pure NAD+ Sublingual powder
			Alive By Nature, Inc.
			2574 Whispering Pines Dr.
			Fleming Island, FL 32003
			alivebynature.com
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Liquid NAD+ Sublingual drops
			Alive By Nature, Inc.
			2574 Whispering Pines Dr.
			Fleming Island, FL 32003
			alivebynature.com
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Pure NAD+ Nasal Spray,
			Alive By Nature, Inc.
			2574 Whispering Pines Dr.
			Fleming Island, FL 32003
			alivebynature.com
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			NMNs Sublingual tablets (30 ct and 240 ct)
			Alive By Nature, Inc.
			2574 Whispering Pines Dr.
			Fleming Island, FL 32003
			alivebynature.com
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Pure NMN Sublingual powder
			Alive By Nature, Inc.
			2574 Whispering Pines Dr.
			Fleming Island, FL 32003
			alivebynature.com
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Pulverexx
			Doctor Eden LLC
			10030 NW 6th Terr.
			Miami, FL 33172
			doctoreden.com; facebook.com/dredenhealth/; twitter.com/DrMEden; pinterest.com/drmarioeden
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			GF20 Plus Oral Spray
			Leading Edge Health
			100 Fidelitone Way
			Elizabethton, TN 37643
			leadingedgehealth.com; genf20.com; gen20.com
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			GF20 Plus Capsules
			Leading Edge Health
			100 Fidelitone Way
			Elizabethton, TN 37643
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Moses Kit (Moses Cream + Moses Oil)
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			IQ+ Joy, Sleep, Anxiety
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Essential Eye Oil for Glaucoma
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Certified Organic Frankincense
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			High Blood Pressure Support
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Moses Lip Balm-Rose
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Moses Lip Balm-Natural
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Fix It All
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Moses Oils
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Moses Cream
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Clear Nose
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/25/2019
			Hair Maximizer
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Food; Drugs07/25/2019
			Cancer Support (Big C Support)
			Bible Healing Oils
			111 5th Avenue East
			Buckeye, AZ 85326
			biblehealingoils.net
			Unapproved New Drugs
			Online Advisory Letter
			Foods; Drugs07/22/2019
			Bido CBD for Pets
			Curaleaf, Inc.
			301 Edgewater Place Suite 405, Wakefield, MA 01880
			curaleafhemp.com
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2019
			CBD Disposable Vape Pen
			Curaleaf, Inc.
			301 Edgewater Place Suite 405, Wakefield, MA 01880
			curaleafhemp.com
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2019
			CBD Tincture
			Curaleaf, Inc.
			301 Edgewater Place Suite 405, Wakefield, MA 01880
			curaleafhemp.com
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2019
			CBD Pain-Relief Patch
			Curaleaf, Inc.
			301 Edgewater Place Suite 405, Wakefield, MA 01880
			curaleafhemp.com
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/22/2019
			CBD Lotion
			Curaleaf, Inc.
			301 Edgewater Place Suite 405, Wakefield, MA 01880
			curaleafhemp.com
			Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
			Warning Letter
			Drugs07/16/2019
			Reduktis Max
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs07/16/2019
			Black Storm
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/16/2019
			Big Penis
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/16/2019
			Boss Lion 9000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/16/2019
			De Guo Heijin Gang
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/16/2019
			Herb Viagra
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/16/2019
			La Pepa Negra
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/16/2019
			Odimafo Powerful Tablet 200 mg
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/16/2019
			Plant Vigra
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/16/2019
			Shengjingpian
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/16/2019
			Vigour 800 mg
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/01/2019
			Lipro Dietary Capsule
			Various Distributors
			n/a
			liprodietpill.com
			Undeclared tadalafil
			Public Notification
			Drugs06/26/2019
			Adelgasin Plus
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and N-desmethyl sibutramine
			Public Notification
			Drugs06/26/2019
			Super Slimming Herb
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs06/26/2019
			Lishou Fuling Jiaonang
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and N-desmethyl sibutramine
			Public Notification
			Drugs06/26/2019
			Detoxi Slim
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs06/26/2019
			Absolute Nine Slim
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and N-desmethyl sibutramine
			Public Notification
			Drugs06/26/2019
			Peru Maca
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs06/26/2019
			Germany Black Gorilla
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs06/25/2019
			12 Gram Kratom Powder Samples
			Cali Botanicals, LLC
			500 Sibley Street, Folsom, CA 95630
			calibotanicals.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs06/25/2019
			Borneo yellow Vein Kratom
			Cali Botanicals, LLC
			500 Sibley Street, Folsom, CA 95630
			calibotanicals.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs06/25/2019
			Bali Kratom Powder
			Cali Botanicals, LLC
			500 Sibley Street, Folsom, CA 95630
			calibotanicals.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs06/25/2019
			Cali's Best Premium Powder Mix
			Cali Botanicals, LLC
			500 Sibley Street, Folsom, CA 95630
			calibotanicals.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs06/25/2019
			Cali's Premium Special Reserve Kratom Powder
			Cali Botanicals, LLC
			500 Sibley Street, Folsom, CA 95630
			calibotanicals.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs06/25/2019
			Enhanced Maeng Da Capsules
			Cali Botanicals, LLC
			500 Sibley Street, Folsom, CA 95630
			calibotanicals.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs06/25/2019
			Green Malay Kratom Caps
			Cali Botanicals, LLC
			500 Sibley Street, Folsom, CA 95630
			calibotanicals.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs06/25/2019
			Kratom Capsule Samples
			Cali Botanicals, LLC
			500 Sibley Street, Folsom, CA 95630
			calibotanicals.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs06/25/2019
			Full Spectrum 50x Kratom Tincture
			Cali Botanicals, LLC
			500 Sibley Street, Folsom, CA 95630
			calibotanicals.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs06/25/2019
			Super Enhanced Bali Kratom
			Cali Botanicals, LLC
			500 Sibley Street, Folsom, CA 95630
			calibotanicals.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs06/25/2019
			Super Enhanced Maeng Da Kratom
			Cali Botanicals, LLC
			500 Sibley Street, Folsom, CA 95630
			calibotanicals.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs06/23/2020
			Anti-Viral Immune Enhancement Capsules
			Golden Nutrition Inc.
			Opa Locka, FL
			goldennutrition.com
			Unsubstantiated Health Claims on Label
			Recall
			Foods06/06/2019
			SpiroNIL
			PRL, Inc.
			84 West Fourth Avenue, Lobelville, TN 37097-3267
			forestcenterherbs.com
			CGMP/Dietary Supplement/Adulterated/Misbranded
			Warning Letter
			Foods06/06/2019
			General Formula
			PRL, Inc.
			84 West Fourth Avenue, Lobelville, TN 37097-3267
			forestcenterherbs.com
			CGMP/Dietary Supplement/Adulterated/Misbranded
			Warning Letter
			Foods06/06/2019
			Black Walnut
			PRL, Inc.
			84 West Fourth Avenue, Lobelville, TN 37097-3267
			forestcenterherbs.com
			CGMP/Dietary Supplement/Adulterated/Misbranded
			Warning Letter
			Foods06/06/2019
			Alfalfa Herbal Tonic
			PRL, Inc.
			84 West Fourth Avenue, Lobelville, TN 37097-3267
			forestcenterherbs.com
			CGMP/Dietary Supplement/Adulterated/Misbranded
			Warning Letter
			Foods06/06/2019
			Kidney Formula #1
			PRL, Inc.
			84 West Fourth Avenue, Lobelville, TN 37097-3267
			forestcenterherbs.com
			CGMP/Dietary Supplement/Adulterated/Misbranded
			Warning Letter
			Foods06/06/2019
			Kidney Formula #2
			PRL, Inc.
			84 West Fourth Avenue, Lobelville, TN 37097-3267
			forestcenterherbs.com
			CGMP/Dietary Supplement/Adulterated/Misbranded
			Warning Letter
			Foods06/06/2019
			MicroNIL
			PRL, Inc.
			84 West Fourth Avenue, Lobelville, TN 37097-3267
			forestcenterherbs.com
			CGMP/Dietary Supplement/Adulterated/Misbranded
			Warning Letter
			Foods05/22/2019
			Man Fuel Xtreme Edition
			Various Distributors
			n/a
			gomanfuel.com
			Undeclared sildenafil, dithiodesmethyl carbodenafil and desmethyl carbodenafil
			Public Notification
			Drugs05/22/2019
			Man Fuel Male Enhancement Shooter (Tropical Fruit Flavor)
			Various Distributors
			n/a
			gomanfuel.com
			Undeclared tadalafil and desmethyl carbodenafil
			Public Notification
			Drugs05/16/2019
			Green Bali Powder
			KratomNC
			925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335
			kratomnc.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs05/16/2019
			Red Indo Powder
			KratomNC
			925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335
			kratomnc.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs05/16/2019
			Gold Bali Powder
			KratomNC
			925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335
			kratomnc.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs05/16/2019
			White Indo Powder
			KratomNC
			925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335
			kratomnc.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs05/16/2019
			Super White Powder
			KratomNC
			925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335
			kratomnc.com
			Unapproved New Drug/Misbranded
			Warning Letter
			Drugs05/15/2019
			Active Herb YinVive
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/15/2019
			Active Herb Ease Tonic
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/15/2019
			Active Herb LiverVive
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/15/2019
			Guang Ci Tang Vertigoff (Ban Xia Bai Zhu Tian Ma Pian)
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/15/2019
			Guang Ci Tang Nasopass (Bi Yan Pian)
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/15/2019
			Guang Ci Tang NeuroSoothe (Chai Hu Long Gu Lu Mu Li Pian (Wan)
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/15/2019
			Guang Ci Tang JointsJoy (Du Huo Ji Sheng Wan)
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/15/2019
			Guang Ci Tang Cardiovigor (Fu Fang Dan Shen Pian)
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/15/2019
			Guang Ci Tang Kudzu Relaxe (Ge Gen Tang Pian)
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/15/2019
			Guang Ci Tang Stomacare (Huo Xiang Zheng Qi Pian)
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/15/2019
			Guang Ci Tang Breathmooth (Ke Chuan Pian)
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/15/2019
			Guang Ci Tang Stonepass (Li Shui Pai Shi Pian)
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/15/2019
			Guang Ci Tang Bupleuri Relaxe (Xiao Chai Hu Pian (Wan)
			ActiveHerb Technology, Inc.
			8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
			activeherb.com
			Unapproved New Drugs/Misbranded
			Warning Letter
			Foods05/07/2019
			Topical Sunscreen and Anti-Blemish Over-the-Counter (OTC) Drug Products
			AMMD Labs, LLC
			1501 Green Rd Ste J, Pompano Beach, FL 33064
			n/a
			CGMP/Finished Pharmaceuticals/Adulterated
			Warning Letter
			Drugs05/07/2019
			The BEAST Capsules
			STIFF BOY LLC
			n/a
			n/a
			Undeclared sildenafil
			Recall
			Drugs05/02/2019
			Puriton Eye Relief Drops
			Kadesh International
			7341 Lincoln Way, Garden Grove, CA 92841
			puriton.us
			CGMP/Finished Pharmaceuticals/Adulterated
			Warning Letter
			Drugs05/02/2019
			Puriton Intimate Disinfection Spray
			Kadesh International
			7341 Lincoln Way, Garden Grove, CA 92841
			puriton.us
			CGMP/Finished Pharmaceuticals/Adulterated
			Warning Letter
			Drugs04/23/2019
			Fever~Infection
			Newton Laboratories Inc DBA Newton Homeopathics
			455 Gees Mill Business Ct. NE, Conyers, GA 30013
			newtonlabs.net
			CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
			Warning Letter
			Drugs04/23/2019
			Food Allergies~Additives
			Newton Laboratories Inc DBA Newton Homeopathics
			455 Gees Mill Business Ct. NE, Conyers, GA 30013
			newtonlabs.net
			CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
			Warning Letter
			Drugs04/23/2019
			Blues~Mood~Emotions
			Newton Laboratories Inc DBA Newton Homeopathics
			455 Gees Mill Business Ct. NE, Conyers, GA 30013
			newtonlabs.net
			CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
			Warning Letter
			Drugs04/23/2019
			Vaccination~Illness
			Newton Laboratories Inc DBA Newton Homeopathics
			455 Gees Mill Business Ct. NE, Conyers, GA 30013
			newtonlabs.net
			CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
			Warning Letter
			Drugs04/09/2019
			Platinum 40000
			SD Imports, LLC
			n/a
			n/a
			Undeclared sildenafil
			Recall
			Drugs04/05/2019
			Kopi Jantan Tradisional Natural Herbs Coffee
			Brian Richardson dba In Tha Pink
			n/a
			n/a
			Undeclared sildenafiland tadalafil
			Recall
			Drugs03/22/2019
			LEOPARD Miracle Honey
			USA LESS
			PO Box 250-138, Brooklyn, NY 11225
			n/a
			Undeclared sildenafil
			Recall
			Drugs03/21/2019
			BLUEFUSION Capsules
			Ata Int. Inc.
			n/a
			n/a
			Undeclared sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein
			Recall
			Drugs02/08/2019
			Indian Herb
			McDaniel Life-Line LLC
			n/a
			n/a
			Marketed without an approved NDA/ANDA
			Recall
			Drugs01/29/2019
			Silver Bullet 10x
			Nature's Rx
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Recall
			Drugs01/28/2019
			GoLean Detox
			GoLean Detox US
			4832 Central Ave, Charlotte, NC 28205-5844
			facebook.com/GoLean-detox-US-1592137147568285/
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs
			Warning Letter01/28/2019
			Ultra Fit
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and N-desmethylsibutramine
			Public Notification
			Drugs01/28/2019
			Slimmer Extreme Thermogenic Formula
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs01/28/2019
			Slim Bio Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine, N-desmethylsibutramine, sildenafil, tadalafil, benproperine and diphenhydramine
			Public Notification
			Drugs01/28/2019
			Slimina
			Various Distributors
			n/a
			effectivehealthyproducts.com
			Undeclared sibutramine
			Public Notification
			Drugs01/28/2019
			Red Stallion Extra Strong
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared tadalafil
			Public Notification
			Drugs01/28/2019
			Natural V=GRA
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs01/28/2019
			Yong Gang
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs01/28/2019
			Golden Ant
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs01/28/2019
			Instinct Best Sexual Enjoyment
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs01/28/2019
			Nectar Del Amor
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs01/10/2013
			1 Day Diet
			Various Distributors
			n/a
			n/a
			Undeclared N-desmethylsibutramine
			Public Notification
			Drugs01/10/2019
			Black King Kong
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared moroxydine and sildenafil
			Public Notification
			Drugs01/10/2019
			The Silver Bullet
			Various Distributors
			n/a
			ebay.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs01/08/2019
			Rhino 5K
			Happy Together, Inc.
			504 Muirfield Dr., Atlantis FL, 33462
			n/a
			Undeclared sildenafil and tadalafil
			Recall
			Drugs12/10/2018
			On Demand
			Various Distributors
			n/a
			goodlifeondemand.com
			Undeclared sildenafil
			Public Notification
			Drugs11/30/2018
			Willy Go Wild
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs11/30/2018
			MOB Candy
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs11/21/2018
			America Treasure
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/08/2018
			Memory Revitalizer
			Alzheimer's Corporation (ALZcorp)
			6000 Uptown Blvd., NE Suite 308
			Albuquerque, NM 87110
			lifeimagined.com;
			alzheimerscorp.com;
			memoryrevitalizer.com;
			alzcorp.com
			New drugs
			Online Advisory Letter
			Foods; Drugs11/08/2018
			Cerebara GPC (L-Alpha glycerophosphocholine)
			Alzheimer's Corporation (ALZcorp)
			6000 Uptown Blvd., NE Suite 308
			Albuquerque, NM 87110
			lifeimagined.com;
			alzheimerscorp.com;
			memoryrevitalizer.com;
			alzcorp.com
			New drugs
			Online Advisory Letter
			Foods; Drugs11/08/2018
			Life Imagined
			Alzheimer's Corporation (ALZcorp)
			6000 Uptown Blvd., NE Suite 308
			Albuquerque, NM 87110
			lifeimagined.com;
			alzheimerscorp.com;
			memoryrevitalizer.com;
			alzcorp.com
			New drugs
			Online Advisory Letter
			Foods; Drugs11/08/2018
			Mind and Memory Support
			Alzheimer's Organization
			509 Riverside Drive, Suite 302
			Stuart, FL 34994
			alzheimersorganization.org
			New drugs
			Online Advisory Letter
			Foods; Drugs11/08/2018
			Leopard Secret Miracle Honey
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil
			Public Notification
			Drugs11/08/2018
			Best Leopard Miracle of Honey
			Various Distributors
			n/a
			Examination of imported goods
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs11/08/2018
			Gold Max Blue
			Various Distributors
			n/a
			goldmaxblue.com
			Undeclared sildenafil
			Public Notification
			Drugs11/07/2018
			BALI Greens
			Dr. Fitt Intelligent Designs, LLC
			812 S Georgia St
			Amarillo, TX 79106
			drfitt.com;
			drfittinfo.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs
			Warning Letter11/07/2018
			BALI Purples
			Dr. Fitt Intelligent Designs, LLC
			812 S Georgia St
			Amarillo, TX 79106
			drfitt.com;
			drfittinfo.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs
			Warning Letter11/07/2018
			Black Seed Oil
			Dr. Fitt Intelligent Designs, LLC
			812 S Georgia St
			Amarillo, TX 79106
			drfitt.com;
			drfittinfo.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs
			Warning Letter11/07/2018
			DHEA Capsules
			Dr. Fitt Intelligent Designs, LLC
			812 S Georgia St
			Amarillo, TX 79106
			drfitt.com;
			drfittinfo.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs
			Warning Letter11/07/2018
			Lugol’s Solution 2% Drops
			Dr. Fitt Intelligent Designs, LLC
			812 S Georgia St
			Amarillo, TX 79106
			drfitt.com;
			drfittinfo.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs
			Warning Letter11/07/2018
			Robenyzme Capsules
			Dr. Fitt Intelligent Designs, LLC
			812 S Georgia St
			Amarillo, TX 79106
			drfitt.com;
			drfittinfo.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs
			Warning Letter11/07/2018
			OMG Max Drops
			Dr. Fitt Intelligent Designs, LLC
			812 S Georgia St
			Amarillo, TX 79106
			drfitt.com;
			drfittinfo.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs
			Warning Letter11/07/2018
			New Dawn Capsules
			Dr. Fitt Intelligent Designs, LLC
			812 S Georgia St
			Amarillo, TX 79106
			drfitt.com;
			drfittinfo.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs
			Warning Letter11/07/2018
			Vitamin C with R-Lipoic Acid
			Dr. Fitt Intelligent Designs, LLC
			812 S Georgia St
			Amarillo, TX 79106
			drfitt.com;
			drfittinfo.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs
			Warning Letter11/07/2018
			Aromatherapy for Dementia Memory Kit Premier Edition
			Healthcare Products, LLC d/b/a The Alzheimer's Store
			d/b/a MindCare Store
			340 Royal Poinciana Way, #317 
			Palm Beach, FL 33480
			alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
			New Drugs
			Online Advisory Letter
			Foods; Drugs11/07/2018
			Aromatherapy for Dementia Memory Kit Second Edition
			Healthcare Products, LLC d/b/a The Alzheimer's Store
			d/b/a MindCare Store
			340 Royal Poinciana Way, #317 
			Palm Beach, FL 33480
			alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
			New Drugs
			Online Advisory Letter
			Foods; Drugs11/07/2018
			Bodyguard Blend Essential Oil
			Healthcare Products, LLC d/b/a The Alzheimer's Store
			d/b/a MindCare Store
			340 Royal Poinciana Way, #317 
			Palm Beach, FL 33480
			alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
			New Drugs
			Online Advisory Letter
			Foods; Drugs11/07/2018
			ClearMind Blend Essential Oil
			Healthcare Products, LLC d/b/a The Alzheimer's Store
			d/b/a MindCare Store
			340 Royal Poinciana Way, #317 
			Palm Beach, FL 33480
			alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
			New Drugs
			Online Advisory Letter
			Foods; Drugs11/07/2018
			Lavender Essential Oil
			Healthcare Products, LLC d/b/a The Alzheimer's Store
			d/b/a MindCare Store
			340 Royal Poinciana Way, #317 
			Palm Beach, FL 33480
			alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
			New Drugs
			Online Advisory Letter
			Foods; Drugs11/07/2018
			Attention Aromatherapy Patch
			Healthcare Products, LLC d/b/a The Alzheimer's Store
			d/b/a MindCare Store
			340 Royal Poinciana Way, #317 
			Palm Beach, FL 33480
			alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
			New Drugs
			Online Advisory Letter
			Foods; Drugs11/07/2018
			Calming Aromatherapy Patch
			Healthcare Products, LLC d/b/a The Alzheimer's Store
			d/b/a MindCare Store
			340 Royal Poinciana Way, #317 
			Palm Beach, FL 33480
			alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
			New Drugs
			Online Advisory Letter
			Foods; Drugs11/07/2018
			Lavender Aromatherapy Patch
			Healthcare Products, LLC d/b/a The Alzheimer's Store
			d/b/a MindCare Store
			340 Royal Poinciana Way, #317 
			Palm Beach, FL 33480
			alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
			New Drugs
			Online Advisory Letter
			Foods; Drugs11/07/2018
			Perk Up Aromatherapy Patch
			Healthcare Products, LLC d/b/a The Alzheimer's Store
			d/b/a MindCare Store
			340 Royal Poinciana Way, #317 
			Palm Beach, FL 33480
			alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
			New Drugs
			Online Advisory Letter
			Foods; Drugs11/07/2018
			Refresh Aromatherapy Patch
			Healthcare Products, LLC d/b/a The Alzheimer's Store
			d/b/a MindCare Store
			340 Royal Poinciana Way, #317 
			Palm Beach, FL 33480
			alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
			New Drugs
			Online Advisory Letter
			Foods; Drugs11/07/2018
			Rested Aromatherapy Patch
			Healthcare Products, LLC d/b/a The Alzheimer's Store
			d/b/a MindCare Store
			340 Royal Poinciana Way, #317 
			Palm Beach, FL 33480
			alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
			New Drugs
			Online Advisory Letter
			Foods; Drugs11/07/2018
			Aromatherapy Patch Sample Pack
			Healthcare Products, LLC d/b/a The Alzheimer's Store
			d/b/a MindCare Store
			340 Royal Poinciana Way, #317 
			Palm Beach, FL 33480
			alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
			New Drugs
			Online Advisory Letter
			Foods; Drugs11/07/2018
			Essential Oils including Dementia/Alzheimer's (Day) Synergy Oil and Dementia/Alzheimer's (Night) Synergy Oil
			This Wonderful Life New Age Shop
			M-0-7, Plaza Damas
			60 Jalan Sri Hartamas 1
			Kuala Lumpur, 50480
			Malaysia MY
			twlshop.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs10/15/2018
			Zero Xtreme
			Fat Burners Zone
			n/a
			n/a
			Undeclared sibutramine
			Recall
			Drugs10/01/2018
			FX75000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs10/01/2018
			Baschi Quick Slimming Capsule
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and N-desmethylsibutramine
			Public Notification
			Drugs10/01/2018
			In Shape
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs10/01/2018
			Like Slim Coffee
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs10/01/2018
			Shengan Natural Model
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs10/01/2018
			Green Lean Body Capsule
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and N-desmethylsibutramine
			Public Notification
			Drugs10/01/2018
			Strong Horses
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs10/01/2018
			USA for Woman
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs10/01/2018
			V-Max
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs10/01/2018
			ProSolution
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs08/31/2018
			Easy 2 Slim
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs08/31/2018
			Slimming Capsule
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs08/31/2018
			Extenze Nutritional Supplement
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs08/31/2018
			BodySlim Herbal
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs08/31/2018
			Extenze Plus
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs08/31/2018
			PremierZen Gold 4000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs08/31/2018
			5K
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs08/31/2018
			Panther Power Platinum 11000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs08/31/2018
			Nuvitra
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and fluoxetine
			Public Notification
			Drugs08/31/2018
			XXXPlosion Ultra
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs08/29/2018
			Cell Stop
			Optimal Health Knowledge LLC
			2177 NE 62nd Ct.
			Fort Lauderdale, FL 33308
			optimalhealthknowledge.com;
			facebook.com/optimalhealthknowledge/
			New Drugs
			Online Advisory Letter
			Foods; Drugs08/29/2018
			Cardio Forte
			Optimal Health Knowledge LLC
			2177 NE 62nd Ct.
			Fort Lauderdale, FL 33308
			optimalhealthknowledge.com;
			facebook.com/optimalhealthknowledge/
			New Drugs
			Online Advisory Letter
			Foods; Drugs08/29/2018
			Inflam-Alieve
			Optimal Health Knowledge LLC
			2177 NE 62nd Ct.
			Fort Lauderdale, FL 33308
			optimalhealthknowledge.com;
			facebook.com/optimalhealthknowledge/
			New Drugs
			Online Advisory Letter
			Foods; Drugs08/29/2018
			Liv Assist
			Optimal Health Knowledge LLC
			2177 NE 62nd Ct.
			Fort Lauderdale, FL 33308
			optimalhealthknowledge.com;
			facebook.com/optimalhealthknowledge/
			New Drugs
			Online Advisory Letter
			Foods; Drugs08/29/2018
			Mindful
			Optimal Health Knowledge LLC
			2177 NE 62nd Ct.
			Fort Lauderdale, FL 33308
			optimalhealthknowledge.com;
			facebook.com/optimalhealthknowledge/
			New Drugs
			Online Advisory Letter
			Foods; Drugs08/29/2018
			GI Comfort
			Optimal Health Knowledge LLC
			2177 NE 62nd Ct.
			Fort Lauderdale, FL 33308
			optimalhealthknowledge.com;
			facebook.com/optimalhealthknowledge/
			New Drugs
			Online Advisory Letter
			Foods; Drugs08/29/2018
			Tranquil
			Optimal Health Knowledge LLC
			2177 NE 62nd Ct.
			Fort Lauderdale, FL 33308
			optimalhealthknowledge.com;
			facebook.com/optimalhealthknowledge/
			New Drugs
			Online Advisory Letter
			Foods; Drugs8/10/2018
			Ding Ji Wei Ge
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/31/2018
			Black Rhino 25000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/31/2018
			Gold Rhino 25000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/31/2018
			Boss Rhino 15000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/31/2018
			Platinum Rhino 25000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/31/2018
			Krazzy Rhino
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/16/2018
			Rhino 8 Platinum 8000
			Various Distributors
			n/a
			n/a
			Undeclared N-desmethylsibutramine, phenolphthalein, diclofenac, and sildenafil
			Public Notification
			Drugs07/11/2018
			Platinum Maximum Strength Blue Pill Version
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sibutramine and phenolphthalein
			Recall
			Drugs
			Consent Decree07/11/2018
			Slimming Plus Advanced Weight Loss
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sildenafil
			Recall
			Drugs
			Consent Decree07/11/2018
			African Viagra
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sildenafil
			Recall
			Drugs
			Consent Decree07/11/2018
			GINSENG
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sildenafil
			Recall
			Drugs
			Consent Decree07/11/2018
			African Superman
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sildenafil
			Recall
			Drugs
			Consent Decree07/11/2018
			Old Chinese
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sildenafil
			Recall
			Drugs
			Consent Decree07/11/2018
			Lean Extreme Max
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sibutramine
			Recall
			Drugs
			Consent Decree07/11/2018
			X-treme Beauty Slim
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sibutramine
			Recall
			Drugs
			Consent Decree07/11/2018
			African Superman - Top-Class Permanence Tablet
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sildenafil
			Recall
			Drugs
			Consent Decree07/11/2018
			Slim Evolution
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared diclofenac
			Recall
			Drugs
			Consent Decree07/11/2018
			Fat Loss Slimming Beauty
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sibutramine and phenolphthalein
			Recall
			Drugs
			Consent Decree07/11/2018
			Fruta Planta
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sibutramine and phenolphthalein
			Recall
			Drugs
			Consent Decree07/11/2018
			Botanical Slimming
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared API
			Recall
			Drugs
			Consent Decree07/11/2018
			Slim Body
			MyNicNaxs, LLC
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared API
			Recall
			Drugs
			Consent Decree07/09/2018
			Asunsa
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine, N-desmethylsibutramine, benzylsibutramine, phenolphthalein and diclofenac
			Public Notification
			Drugs07/09/2018
			C.U. Plus
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs07/09/2018
			Lyn DTOX FS3
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and N-desmethylsibutramine
			Public Notification
			Drugs07/09/2018
			Dale Mas
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs07/09/2018
			Grakcu Capsule
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs07/09/2018
			Maximum Powerful
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/03/2018
			Body Shape Weight Loss
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared phenolphthalein
			Public Notification
			Drugs07/03/2018
			Row of Antibody Pil
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs07/03/2018
			Chong Cao Qiang Shen Wang
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared phenolphthalein
			Public Notification
			Drugs07/03/2018
			Adipotrim XT
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared phenolphthalein
			Public Notification
			Drugs07/03/2018
			Maxidus
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs06/20/2018
			Gold Viagra
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs06/20/2018
			AB Slim
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine, phenolphthalein and sildenafil
			Public Notification
			Drugs06/20/2018
			Adriana Balance S
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs06/20/2018
			Black Stallion 35000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs06/20/2018
			XXXPlosion
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs06/07/2018
			PAYA Dietary Supplement Product
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs09/06/2018
			Purblack
			Adaptive Energy LLC
			109 E 17th St. Ste 4, Cheyenne, WY 82001
			purblack.com
			New Drug/Misbranded
			Warning Letter
			Foods
			Close-out Letter06/07/2018
			Crossroads Wellness Beverage
			Up Inya Gear
			22 Centennial St., Fairfield, PA 17320
			crossroads2freeedom.com; upinyabeverages.com
			New Drug/Misbranded
			Warning Letter
			Foods
			Close-out Letter05/18/2018
			Solaricare
			Pharmacy Direct, PDU
			8 The Green, Suite 5871, Dover, DE 19901
			solaricare.com
			New Drug/Labeling/Misbranded
			Warning Letter
			Foods
			Close-out Letter05/17/2018
			7K
			Shoreside Enterprises, Inc.
			6345 Newtown Circle A-3, Tampa, FL 33615
			n/a
			Undeclared sildenafil and/or tadalafil
			Recall
			Drugs05/17/2018
			Poseidon 4500 (Extreme 1000 mg)
			Shoreside Enterprises, Inc.
			6345 Newtown Circle A-3, Tampa, FL 33615
			n/a
			Undeclared sildenafil and/or tadalafil
			Recall
			Drugs05/14/2018
			MediViral Extra Strength Herpes Treatment
			MediViral, Inc
			PO Box 56822
			Los Angeles, CA 91413
			mediviral.com;
			twitter.com/mediviral
			New Drugs
			Online Advisory Letter
			Foods; Drugs05/14/2018
			MediViral Extra Strength Herpes Topical Treatment
			MediViral, Inc
			PO Box 56822
			Los Angeles, CA 91413
			mediviral.com;
			twitter.com/mediviral
			New Drugs
			Online Advisory Letter
			Foods; Drugs05/14/2018
			Anti-Stroke
			Olivia’s Healing Herbs
			1102 Edgefield St.
			Killeen, TX 75649-2112
			oliviashealingherbs.com
			New Drugs
			Online Advisory Letters
			Foods; Drugs05/14/2018
			Bones
			Olivia’s Healing Herbs
			1102 Edgefield St.
			Killeen, TX 75649-2112
			oliviashealingherbs.com
			New Drugs
			Online Advisory Letters
			Foods; Drugs05/14/2018
			Viral-X
			Olivia’s Healing Herbs
			1102 Edgefield St.
			Killeen, TX 75649-2112
			oliviashealingherbs.com
			New Drugs
			Online Advisory Letters
			Foods; Drugs05/14/2018
			Candida
			Olivia’s Healing Herbs
			1102 Edgefield St.
			Killeen, TX 75649-2112
			oliviashealingherbs.com
			New Drugs
			Online Advisory Letters
			Foods; Drugs05/14/2018
			Iron Infusion
			Olivia’s Healing Herbs
			1102 Edgefield St.
			Killeen, TX 75649-2112
			oliviashealingherbs.com
			New Drugs
			Online Advisory Letters
			Foods; Drugs05/14/2018
			Mental Focus
			Olivia’s Healing Herbs
			1102 Edgefield St.
			Killeen, TX 75649-2112
			oliviashealingherbs.com
			New Drugs
			Online Advisory Letters
			Foods; Drugs05/14/2018
			Natural Cancer Fighter
			Olivia’s Healing Herbs
			1102 Edgefield St.
			Killeen, TX 75649-2112
			oliviashealingherbs.com
			New Drugs
			Online Advisory Letters
			Foods; Drugs05/14/2018
			Sugar Diabetes Control
			Olivia’s Healing Herbs
			1102 Edgefield St.
			Killeen, TX 75649-2112
			oliviashealingherbs.com
			New Drugs
			Online Advisory Letters
			Foods; Drugs05/14/2018
			Niagra
			Olivia’s Healing Herbs
			1102 Edgefield St.
			Killeen, TX 75649-2112
			oliviashealingherbs.com
			New Drugs
			Online Advisory Letters
			Foods; Drugs05/14/2018
			“Honey, I’m Home” Body Wash
			Olivia’s Healing Herbs
			1102 Edgefield St.
			Killeen, TX 75649-2112
			oliviashealingherbs.com
			New Drugs
			Online Advisory Letters
			Foods; Drugs05/14/2018
			“Ancient Healing Herbs” Body Wash
			Olivia’s Healing Herbs
			1102 Edgefield St.
			Killeen, TX 75649-2112
			oliviashealingherbs.com
			New Drugs
			Online Advisory Letters
			Foods; Drugs05/14/2018
			“Cinnamon Sensations” Body Wash
			Olivia’s Healing Herbs
			1102 Edgefield St.
			Killeen, TX 75649-2112
			oliviashealingherbs.com
			New Drugs
			Online Advisory Letters
			Foods; Drugs05/14/2018
			Best Candy
			Various Distributors
			n/a
			Examination of Imported Goods
			Undeclared nortadalafil
			Public Notification
			Drugs03/28/2018
			Black Lion Pill
			Various Distributors
			n/a
			rakuten.com
			Undeclared sildenafil
			Public Notification
			Drugs03/28/2018
			Red Zone Xtreme 3000
			Various Distributors
			n/a
			ebay.com
			Undeclared tadalafil
			Public Notification
			Drugs03/28/2018
			Rhino 69 Extreme 50000
			AMA Wholesale Inc.
			n/a
			bonanza.com
			Undeclared tadalafil
			Public Notification
			Drugs
			Recall03/28/2018
			Blue Pearl All Natural Male Enhancement Supplement
			Marmex Corp
			n/a
			n/a
			Undeclared sildenafil
			Recall
			Drugs12/06/2017
			After Gallbladder Removal Kit
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Beet Root Capsules
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			30 Day Gallbladder Solution
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Bile Salts
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Choline
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Dissolve GS
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Gallbladder ND Detox
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Gallstone Kit
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Glutathione Liposomal Liquid
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Liver Detox Kit
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Liver ND Detox
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Peppermint Oil Capsules
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Tranquinol
			Gallbladder Attack
			n/a
			gallbladderattack.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Prostalgene Oral Drops
			Prostalgene LLC
			n/a
			prostalgene.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Shilajit Resin
			Healthy Nutrition Group LLC
			n/a
			naturalshilajit.com;
			organicagsolutions.org
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			NutriHoney
			Healthy Nutrition Group LLC
			n/a
			naturalshilajit.com;
			organicagsolutions.org
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Bulk Shilajit
			Healthy Nutrition Group LLC
			n/a
			naturalshilajit.com;
			organicagsolutions.org
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Combination Herpes Treatment
			Synergy Health Solutions
			n/a
			cure4herpes.com;
			treatment4herpes.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			L-Lysine
			Synergy Health Solutions
			n/a
			cure4herpes.com;
			treatment4herpes.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Tribulus
			Synergy Health Solutions
			n/a
			cure4herpes.com;
			treatment4herpes.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Astragalus
			Synergy Health Solutions
			n/a
			cure4herpes.com;
			treatment4herpes.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Rhodiola
			Synergy Health Solutions
			n/a
			cure4herpes.com;
			treatment4herpes.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Amino Acid Formula (or “Unique Amino Formula”)
			Synergy Health Solutions
			n/a
			cure4herpes.com;
			treatment4herpes.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Curos Essential
			Cura Care, Inc.
			n/a
			getcuros.com
			New Drugs
			Online Advisory Letter
			Foods; Drugs12/06/2017
			Chill6
			Chill6
			26 Valley Forge Cir. West Boylston, MA 01583
			chill6.com
			Unapproved New Drugs/Misbranded
			Online Advisory Letter
			Drugs
			Warning Letter11/30/2017
			Chao Jimengnan
			Nutra Labs Inc.
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs11/30/2017
			Bull
			Nutra Labs Inc.
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs11/22/2017
			Asia Slim Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine, diazepam, and bisacodyl
			Public Notification
			Drugs11/20/2017
			New Stiff Nights Platinum 10k
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			Pro Solution
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			Qibianli
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			Rhino 11 Platinum 11000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			Rhino 12 Titanium 6000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			Rhino 25K 15000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			Rhino 69 Premium 8000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			S.W.A.G. II Platinum 33K
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			V9 Male Sexual Stimulant
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			Tyrannosaurus
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			Fruta Planta Life (Garcinia Cambogia Premium)
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs11/20/2017
			Adipessum Miracle Slimming Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared fluoxetine
			Public Notification
			Drugs11/20/2017
			MenXtrong
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			Blue Diamond Pill
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			Control Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2017
			Blue Pearl All Natural Male Enhancement
			Various Distributors
			n/a
			bluepearlformen.com; bluefusions.com
			Undeclared sildenafil
			Public Notification
			Drugs11/09/2017
			Hard Times for Men
			Various Distributors
			n/a
			blankterrmall.com
			Undeclared sildenafil
			Public Notification
			Drugs10/30/2017
			Linsen Double Caulis Plus (靈仙双藤素)
			Various Distributors
			n/a
			tranpharma.com
			Undeclared dexamethasone
			Public Notification
			Drugs10/10/2017
			Tiger 5000
			Various Distributors
			n/a
			amazon.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs10/04/2017
			A1 Slim
			Kiriko, LLC
			Houston, TX
			n/a
			Undeclared sibutramine, phenolphthalein and N-Desmethyl sibutramine
			Recall
			Drugs09/20/2017
			Vegetable Vigra
			Natures Supplement, Inc.
			n/a
			n/a
			Undeclared sildenafil
			Recall
			Drugs09/20/2017
			Rhino 7 Platinum 5000
			Gadget Island, Inc. dba Gear Isle
			n/a
			gearisle.com
			Undeclared sildenafil and tadalafil
			Recall
			Drugs
			Expanded Recall09/20/2017
			Papa Zen 3300
			Gadget Island, Inc. dba Gear Isle
			n/a
			gearisle.com
			Undeclared sildenafil and tadalafil
			Recall
			Drugs
			Expanded Recall09/20/2017
			Fifty Shades 6000
			Gadget Island, Inc. dba Gear Isle
			n/a
			gearisle.com
			Undeclared sildenafil and tadalafil
			Recall
			Drugs
			Expanded Recall09/20/2017
			Grande X 5800
			Gadget Island, Inc. dba Gear Isle
			n/a
			gearisle.com
			Undeclared sildenafil and tadalafil
			Recall
			Drugs
			Expanded Recall08/31/2017
			Physic Candy - Define
			Various Distributors
			n/a
			physic-candy.com
			Undeclared sibutramine
			Public Notification
			Drugs08/31/2017
			Physic Candy - Curve
			Various Distributors
			n/a
			physic-candy.com
			Undeclared sibutramine
			Public Notification
			Drugs08/01/2017
			AMPT Coffee
			The AMPT Life, LLC
			n/a
			amptcoffee.com
			Undeclared sildenafil, tadalafil and milk
			Public Notification
			Drugs07/24/2017
			Xplode
			EZ Weight Loss TX
			Corpus Christi, TX
			n/a
			Undeclared sibutramine
			Recall
			Drugs07/24/2017
			La Bri's Body Health Atomic
			EZ Weight Loss TX
			Corpus Christi, TX
			n/a
			Undeclared sibutramine
			Recall
			Drugs07/17/2017
			Kingdom Honey for Him
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared tadalafil
			Public Notification
			Drugs07/17/2017
			Kingdom Honey for Her
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared tadalafil
			Public Notification
			Drugs07/17/2017
			Royal Honey VIP
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared tadalafil
			Public Notification
			Drugs07/17/2017
			RHINO 7 Platinum 5000
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs06/29/2017
			Agony Balm
			Hart & Soul Herbal, LLC
			n/a
			hartandsoulherbal.com
			New Drugs
			Online Advisory Letter
			Drugs06/29/2017
			Auburn Oil
			Hart & Soul Herbal, LLC
			n/a
			hartandsoulherbal.com
			New Drugs
			Online Advisory Letter
			Drugs06/29/2017
			Rose of Sharon Salt/Olive Soap
			Hart & Soul Herbal, LLC
			n/a
			hartandsoulherbal.com
			New Drugs
			Online Advisory Letter
			Drugs06/29/2017
			Mudd Bombs
			Hart & Soul Herbal, LLC
			n/a
			hartandsoulherbal.com
			New Drugs
			Online Advisory Letter
			Drugs06/29/2017
			Harmony Castile Soap
			Hart & Soul Herbal, LLC
			n/a
			hartandsoulherbal.com
			New Drugs
			Online Advisory Letter
			Drugs06/29/2017
			Rouse Oil
			Hart & Soul Herbal, LLC
			n/a
			hartandsoulherbal.com
			New Drugs
			Online Advisory Letter
			Drugs06/29/2017
			Dew of the Sea Salt/Olive Soap
			Hart & Soul Herbal, LLC
			n/a
			hartandsoulherbal.com
			New Drugs
			Online Advisory Letter
			Drugs06/29/2017
			Season Infusions
			Hart & Soul Herbal, LLC
			n/a
			hartandsoulherbal.com
			New Drugs
			Online Advisory Letter
			Drugs06/29/2017
			Serenity Castile Soap
			Hart & Soul Herbal, LLC
			n/a
			hartandsoulherbal.com
			New Drugs
			Online Advisory Letter
			Drugs06/29/2017
			PD Complete
			ARS Therapeutics, LLC
			n/a
			alstreatments.com
			New Drugs
			Online Advisory Letter
			Drugs06/29/2017
			ALS Complete
			ARS Therapeutics, LLC
			n/a
			alstreatments.com
			New Drugs
			Online Advisory Letter
			Drugs06/23/2017
			XXX Zone Platinum
			SHH Trading
			n/a
			n/a
			Undeclared sildenafil, tadalafil and dapoxetine
			Public Notification
			Drugs06/23/2017
			Triple X 2000
			SHH Trading
			n/a
			n/a
			Undeclared tadalafil and dapoxetine
			Public Notification
			Drugs06/23/2017
			Triple Premium Zen Gold 1300mg
			SHH Trading
			n/a
			n/a
			Undeclared sildenafil, tadalafil and dapoxetine
			Public Notification
			Drugs06/23/2017
			Macho Man 3000
			SHH Trading
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs06/22/2017
			Monster X 1350
			SHH Trading
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs06/22/2017
			Own the Knight 1750
			SHH Trading
			n/a
			n/a
			Undeclared tadalafil and dapoxetine
			Public Notification
			Drugs06/22/2017
			Royal Master 1500
			SHH Trading
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs06/22/2017
			Triple Miracle Zen Plus 1200mg
			SHH Trading
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs06/22/2017
			Xzone Gold
			SHH Trading
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs06/22/2017
			Man of Steel 2
			Various Distributors
			n/a
			manofsteelpills.com
			Undeclared sildenafil
			Public Notification
			Drugs06/22/2017
			Man of Steel
			Various Distributors
			n/a
			manofsteelpills.com
			Undeclared sildenafil
			Public Notification
			Drugs06/22/2017
			Love Zen 3000
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs06/22/2017
			Super Panther 7K
			Various Distributors
			n/a
			ultraxshop.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs05/25/2017
			Caverflo Natural Herbal Coffee
			Caverflo.com
			n/a
			caverflo.com
			Undeclared sildenafil, tadalafil, and milk
			Recall
			Drugs04/18/2017
			Uproar
			Organic Herbal Supply, Inc.
			n/a
			amazon.com; zrect.com
			Undeclared tadalafil, sildenafil and their analogues
			Recall
			Drugs04/18/2017
			Cummor
			Organic Herbal Supply, Inc.
			n/a
			amazon.com; zrect.com
			Undeclared tadalafil, sildenafil and their analogues
			Recall
			Drugs04/18/2017
			Zrect
			Organic Herbal Supply, Inc.
			n/a
			amazon.com; zrect.com
			Undeclared tadalafil, sildenafil and their analogues
			Recall
			Drugs04/18/2017
			Monkey Business
			Organic Herbal Supply, Inc.
			n/a
			amazon.com; zrect.com
			Undeclared tadalafil, sildenafil and their analogues
			Recall
			Drugs04/18/2017
			Xrect
			Organic Herbal Supply, Inc.
			n/a
			amazon.com; zrect.com
			Undeclared tadalafil, sildenafil and their analogues
			Recall
			Drugs04/18/2017
			Rectalis
			Organic Herbal Supply, Inc.
			n/a
			amazon.com; zrect.com
			Undeclared tadalafil, sildenafil and their analogues
			Recall
			Drugs04/18/2017
			Tornado
			Organic Herbal Supply, Inc.
			n/a
			amazon.com; zrect.com
			Undeclared tadalafil, sildenafil and their analogues
			Recall
			Drugs04/18/2017
			Zdaily
			Organic Herbal Supply, Inc.
			n/a
			amazon.com; zrect.com
			Undeclared tadalafil, sildenafil and their analogues
			Recall
			Drugs04/18/2017
			BigNHard
			Organic Herbal Supply, Inc.
			n/a
			amazon.com; zrect.com
			Undeclared tadalafil, sildenafil and their analogues
			Recall
			Drugs04/18/2017
			Enhancerol Natural Male Enhancement capsules
			Organic Herbal Supply, Inc.
			n/a
			amazon.com; zrect.com
			Undeclared tadalafil, sildenafil and their analogues
			Recall
			Drugs04/18/2017
			Zrect for Women
			Organic Herbal Supply, Inc.
			n/a
			amazon.com; zrect.com
			Undeclared flibanserin
			Recall
			Drugs04/18/2017
			LabidaMAX capsules
			Organic Herbal Supply, Inc.
			n/a
			amazon.com; zrect.com
			Undeclared flibanserin
			Recall
			Drugs03/27/2017
			LaBri’s Body Health Atomic
			Envy Me
			n/a
			n/a
			Undeclared sibutramine
			Recall
			Drugs03/07/2017
			Black Ant
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Indian God Lotion
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Evil Root
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Germany Black Gold
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Germany Niubian
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Hard Ten Days
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Lang Yi Hao (Chaonogsuopian)
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Gold Vigra
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Clalis
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Ye Lang Shen
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Zhansheng Weige Chaoyue Xilishi
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Zhonghua Niubian
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Stree Overlord
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Max Man
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Hu Hu Sheng Wei
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Tiger King
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Viagra 100
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Power V8 Viagra
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Daidiyongshi Xiangganglongshengwu
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Lien Chan for Seven Days
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/07/2017
			Maca Gold
			A&H Focal Inc.
			n/a
			n/a
			Undeclared PDE-5 Inhibitors
			Recall
			Drugs03/03/2017
			Arouse-Plus
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs03/03/2017
			Bazook Bullet
			Various Distributors
			n/a
			n/a
			Undeclared aminotadalafil
			Public Notification
			Drugs02/03/2017
			Platinum Max Strength Blue Pill Version
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs02/03/2017
			Ginseng for Reinforcing Kidney
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs02/03/2017
			Goldreallas Original
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs02/03/2017
			Platinum Weight Solution – Fat Loss Metabolizer
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs02/03/2017
			Slimming Plus Advanced
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs02/02/2017
			X-treme Beauty Slim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs02/02/2017
			Goldreallas XXX
			Various Distributors
			n/a
			groupon.com
			Undeclared sildenafil
			Public Notification
			Drugs02/02/2017
			Shenjingpian
			Various Distributors
			n/a
			ghpnutrition.com
			Undeclared sildenafil
			Public Notification
			Drugs02/02/2017
			Old Chinese
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs02/02/2017
			Lean Extreme Max
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs01/26/2017
			XtraHRD Natural Male Enhancement capsules
			Organic Herbal Supply, Inc.
			n/a
			amazon.com
			Undeclared N-desmethyl tadalafil
			Public Notification
			Drugs
			Recall01/10/2017
			PNC-27
			Patrick, LLC
			NV
			pnc27.com
			Contaminated with the bacteria *Variovorax paradoxus;*contaminated with the bacteria Ralstonia insidiosa
			Drug Safety Alert
			Drugs
			News Release12/22/2016
			Rhino 8 Platinum 8000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			Lang Yi Hao
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			Power Male Sexual Stimulant
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			African Viagra
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			Triple Green Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			Queen Slimming Soft Gel
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs12/22/2016
			Big Penis Male Sexual Stimulant
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			90° Jiushidu Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			Rhino 9 Premium 3500
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			Duramaxxx
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			Rhino 7K 9000 Male Performance Booster
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			Bl4ck 4K Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			Black 3K Plus Male Sexual Enhancement Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			Black Mamba 2 Premium Male Sexual Stimulant
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs12/22/2016
			Rhino 5 1500 Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/29/2016
			Megajex Natural Male Sex Enhancer
			MS Bionic, Inc.
			447 E Gardena Blvd, Gardena, CA 90248-2913
			n/a
			Undeclared tadalafil and sildenafil
			Recall
			Drugs
			Warning Letter11/16/2016
			ABX Weight Loss
			Various Distributors
			n/a
			zxtbeepollenpills.com
			Undeclared sibutramine
			Public Notification
			Drugs11/09/2016
			Supreme Slim 5.7
			Various Distributors
			n/a
			absolutenaturalweightloss.net
			Undeclared phenolphthalein and sildenafil
			Public Notification
			Drugs11/09/2016
			Ready Man!
			Various Distributors
			n/a
			amazon.com
			Undeclared sildenafil
			Public Notification
			Drugs11/07/2016
			Ultimate Body Tox PRO
			Ultimate Body–Tox
			High Point, NC
			ultimatebodytox.com
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall10/19/2016
			Accelerator Boost
			Various Distributors
			n/a
			n/a
			Undeclared phenolphthalein
			Public Notification
			Drugs10/19/2016
			Skinny Bee Diet
			Various Distributors
			n/a
			lovemytrubody.com
			Undeclared desmethylsibutramine, sibutramine, and phenolphthalein
			Public Notification
			Drugs10/19/2016
			Zi Su Body Fat Health II (紫苏瘦身营养素 II)
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs10/19/2016
			Results
			Various Distributors
			n/a
			facebook.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs09/16/2016
			Stiff Bull Herbal Coffee
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared desmethyl carbodenafil
			Public Notification
			Drugs08/30/2016
			Kopi Jantan Tradisional Natural Herbs Coffee
			Bestherbs Coffee LLC
			4250 Claremont Dr, Grand Priarie, TX 75052
			n/a
			Undeclared desmethyl carbodenafil
			Public Notification
			Drugs
			Recall08/16/2016
			Master Zone 1500
			Various Distributors
			n/a
			amazon.com
			Undeclared sildenafil and tadalfil
			Public Notification
			Drugs08/16/2016
			Love4Long
			Various Distributors
			n/a
			amazon.com
			Undeclared sildenafil
			Public Notification
			Drugs08/16/2016
			One More Knight 1750
			Various Distributors
			n/a
			amazon.com
			Undeclared tadalfil and dapoxetine
			Public Notification
			Drugs08/09/2016
			Adelgazantes R-II
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs08/09/2016
			Anaconda Strong Formula
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs08/09/2016
			Boss-Rhino Gold X-tra Strength
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs08/09/2016
			De Guo Hei Bei (徳国黑倍)
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/29/2016
			Ziyinzhuangyang
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/28/2016
			Zi Xiu Tang Beauty Face & Figure Capsule
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared phenolphthalein and fluoxetine
			Public Notification
			Drugs07/28/2016
			Weili (一炮到天亮 or Yi Pao Dao Tian Liang)
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/28/2016
			Ultimate Lean
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and desmethylsibutramine
			Public Notification
			Drugs07/27/2016
			Mang Luk Power Slim
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs07/27/2016
			Libigirl
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/27/2016
			Maxx Easy
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs07/27/2016
			Mang Luk Power Slim
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs07/27/2016
			Power Spring (XXX) Oral Liquid
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/27/2016
			Super Bull 6000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/27/2016
			Slim Fit X
			Various Distributors
			n/a
			jerseyshoresupplements.com
			Undeclared sibutramine and desmethylsibutramine
			Public Notification
			Drugs07/27/2016
			Shangai Ultra X
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/27/2016
			The Golden Root
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/27/2016
			Super Shangai
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs07/22/2016
			Xcelerated Weight Loss Charged Up
			Various Distributors
			n/a
			xceleratedweightloss.com
			Undeclared sibutramine
			Public Notification
			Drugs07/22/2016
			Xcelerated Weight Loss Turbo Charge
			Various Distributors
			n/a
			xceleratedweightloss.com
			Undeclared sibutramine
			Public Notification
			Drugs07/22/2016
			Xcelerated Weight Loss Ultra Max
			Various Distributors
			n/a
			xceleratedweightloss.com
			Undeclared phenolphthalein and sildenafil
			Public Notification
			Drugs07/11/2016
			Extra Slim Plus Acai Berry Weight Loss Formula
			Various Distributors
			n/a
			dreambodyweightloss.com
			Undeclared sibutramine
			Public Notification
			Drugs07/11/2016
			Dream Body Advanced + Acai Weight Loss & Cleanse
			Various Distributors
			Grand Prairie, TX
			dreambodyweightloss.com
			Undeclared sibutramine, fluoxetine and sildenafil
			Public Notification
			Drugs
			Recall07/11/2016
			Dream Body Extreme Gold
			Dream Body Weight Loss
			Grand Prairie, TX
			dreambodyweightloss.com
			Undeclared sibutramine, fluoxetine and sildenafil
			Public Notification
			Drugs
			Recall07/11/2016
			Dream Body Original Formula
			Dream Body Weight Loss
			Grand Prairie, TX
			dreambodyweightloss.com
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall07/11/2016
			SBF Bee Pollen
			Various Distributors
			n/a
			zxtbeepollen.com
			Undeclared sibutramine
			Public Notification
			Drugs06/30/2016
			My Steel Woody
			Various Distributors
			n/a
			mysteelwoody.com
			Undeclared sildenafil
			Public Notification
			Drugs06/07/2016
			Step 2
			The Body Shot Bar
			n/a
			thebodyshotbar.com
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall06/06/2016
			Exhilarate
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine, desmethylsibutramine, and phenolphthalein
			Public Notification
			Drugs06/01/2016
			DR’s Secret Bio Herbs Coffee
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared tadalafil
			Public Notification
			Drugs04/26/2016
			3rd Degree
			Making It A Lifestyle, L.L.C.
			Corpus Christi, TX
			makingitalifestyle.com
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall04/26/2016
			Black Label X
			Making It A Lifestyle, L.L.C.
			Corpus Christi, TX
			makingitalifestyle.com
			Undeclared sildenafil
			Public Notification
			Drugs
			Recall04/26/2016
			Black Gold X Advanced
			Making It A Lifestyle, L.L.C.
			Corpus Christi, TX
			makingitalifestyle.com
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall03/29/2016
			Propell Platinum
			Various Distributors
			n/a
			zxtbeepollenpills.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs03/28/2016
			ENVY BP
			Various Distributors
			n/a
			purelysimpleweightloss.com
			Undeclared sibutramine
			Public Notification
			Drugs03/17/2016
			Salute Capsules
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil, thiosildenafil, and sulfoaildenafil
			Public Notification
			Drugs03/17/2016
			Xerophagy
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs03/17/2016
			ZlimXter Capsules
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs03/17/2016
			Dynamizm Capsules
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification03/17/2016
			Eradicate Capsules
			Various Distributors
			n/a
			x2zero.com
			Undeclared sibutramine and desmethylsibutramine
			Public Notification
			Drugs03/03/2016
			Sextra
			Various Distributors
			n/a
			ishopLSTV.com
			Undeclared sildenafil
			Public Notification
			Drugs02/11/2016
			Zhong Hua Niu Bian
			Various Distributors
			n/a
			zhonghuaniubian.com
			Undeclared sildenafil
			Public Notification
			Drugs02/11/2016
			Weekend Prince
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs02/11/2016
			Bull
			Various Distributors
			n/a
			bullsexpills.com
			Undeclared sildenafil
			Public Notification
			Drugs02/11/2016
			Bull's Genital
			Various Distributors
			n/a
			bullsgenital.com
			Undeclared sildenafil
			Public Notification
			Drugs02/05/2016
			Ninja-X
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and thiosildenafil
			Public Notification
			Drugs02/05/2016
			Golden Night
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and hydroxythiohomosildenafil
			Public Notification
			Drugs02/05/2016
			Ginseng Power-X
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and sulfoaildenafil
			Public Notification
			Drugs02/05/2016
			Boss Number #Six
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs02/05/2016
			Mamba is Hero
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil, desmethyl carbodenafil, and dapoxetine
			Public Notification
			Drugs01/26/2016
			Wonder-Erect Male Pills
			Various Distributors
			n/a
			amazon.com
			Undeclared vardenafil
			Public Notification
			Drugs01/21/2016
			Wonder-Erect Male Gum
			Various Distributors
			n/a
			amazon.com
			Undeclared vardenafil
			Public Notification
			Drugs12/28/2015
			Xtra Zone 2400
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs12/28/2015
			Triple MiracleZen Extreme 1750mg
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil, tadalafil and dapoxetine
			Public Notification
			Drugs12/28/2015
			Eros Power Zone 1900
			Various Distributors
			n/a
			n/a
			Undeclared desmethyl carbodenafil and dapoxetine
			Public Notification
			Drugs12/28/2015
			Triple MiracleZen Gold 1750mg
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil, tadalafil and dapoxetine
			Public Notification
			Drugs12/28/2015
			Rhino Big Horn 3000
			Various Distributors
			n/a
			n/a
			Undeclared desmethyl carbodenafil and sildenafil
			Public Notification
			Drugs12/28/2015
			Rhino 7 Blue 9000
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs12/28/2015
			OrgaZen 3000
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs12/28/2015
			Diamond 3500
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs12/28/2015
			Xtra Zone 2200
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs12/28/2015
			Xtra Zone 2600
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs12/28/2015
			Triple Power Zen Plus 2000
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs12/28/2015
			OrgaZen 3500
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs12/21/2015
			La'Trim Plus
			Various Distributors
			n/a
			bee-xtreme.com
			Undeclared sibutramine
			Public Notification
			Drugs12/19/2015
			Super Herbs
			Various Distributors
			n/a
			mysuperherbs.com
			Undeclared sibutramine and desmethylsiburamine
			Public Notification
			Drugs12/18/2015
			Jenesis
			Various Distributors
			n/a
			beeextremelyamazed.com; beefitamy.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs12/18/2015
			Oasis Bee Pollen
			Various Distributors
			n/a
			beeextremelyamazed.com; beefitamy.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs12/18/2015
			Prime Bee Pollen
			Various Distributors
			n/a
			beeextremelyamazed.com; beefitamy.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs12/18/2015
			Evolve Bee Pollen
			Various Distributors
			n/a
			beeextremelyamazed.com; beefitamy.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs12/18/2015
			X Again Platinum
			Various Distributors
			n/a
			paramount-supplements.com
			Undeclared sildenafil, tadalafil and dapoxetine
			Public Notification
			Drugs12/17/2015
			Thirty Plus
			Various Distributors
			n/a
			getskinny.bigcartel.com
			Undeclared sibutramine
			Public Notification
			Drugs12/17/2015
			Power Tiger-X
			Various Distributors
			n/a
			everestwholesales.com
			Undeclared sulfoaildenafil
			Public Notification
			Drugs12/09/2015
			Pink Bikini
			Lucy's Weight Loss System
			Arlington, TX
			pink.bikini.bigcartel.com
			Undeclared diclofenac
			Recall
			Drugs12/02/2015
			Lipo Escultura
			Various Distributors, including JAT Productos Naturales Corp.
			n/a
			lipoesculturatreatment.com
			Undeclared sibutramine and diclofenac
			Public Notification
			Drugs
			Recall11/19/2015
			Zero Fat
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and fluoxetine
			Public Notification
			Drugs11/19/2015
			Effective Viagra Tablets
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/19/2015
			Slyn Both
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared fluoxetine and orlistat
			Public Notification
			Drugs11/19/2015
			Super Herbs
			Various Distributors
			n/a
			mysuperherbs.com
			Undeclared sibutramine and desmethylsiburamine
			Public Notification
			Drugs11/19/2015
			Rhino X
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/19/2015
			SPCARET Princess Diet
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs11/19/2015
			Perfect Slim Fast Track Slim
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared fluoxetine and orlistat
			Public Notification
			Drugs11/19/2015
			Australia Kangaroo Essence
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/19/2015
			Sex Drive Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs11/19/2015
			XForMan Plus
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs10/29/2015
			Rhino 7 3000
			National Video Supply
			21100 Centre Pointe Park Way, Santa Clarita, CA 91350
			n/a
			Undeclared desmethyl carbondenafil and dapoxetine
			Recall
			Drugs10/29/2015
			Rhino 7 Platinum 3000
			National Video Supply
			21100 Centre Pointe Park Way, Santa Clarita, CA 91350
			n/a
			Undeclared desmethyl carbondenafil and dapoxetine
			Recall
			Drugs10/28/2015
			Rhino 7 3000
			Premiere Sales Group
			21446 Golden Triangle Rd., Santa Clarita, CA 91350
			n/a
			Undeclared desmethyl carbondenafil and dapoxetine
			Recall
			Drugs10/28/2015
			Rhino 7 Platinum 3000
			Premiere Sales Group
			21446 Golden Triangle Rd., Santa Clarita, CA 91350
			n/a
			Undeclared desmethyl carbondenafil and dapoxetine
			Recall
			Drugs10/23/2015
			Fuel Up Plus
			Reesna Inc.
			Canoga Park, CA
			fueluppills.com
			Undeclared hydroxythiohomosildenafil
			Public Notification
			Drugs
			Recall10/23/2015
			Fuel Up High Octane
			Reesna Inc.
			Canoga Park, CA
			fueluppills.com
			Undeclared hydroxythiohomosildenafil
			Public Notification
			Drugs
			Recall10/23/2015
			S.W.A.G.G.E.R Extreme Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs10/23/2015
			Lishou Slimming Coffee
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs10/23/2015
			Xtreme Fat Burner Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared phenolphthalein and sildenafil
			Public Notification
			Drugs10/23/2015
			Tip-Top Shape
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs10/23/2015
			Wild Sexx Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs10/23/2015
			Sex-Love Secret Code Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs10/23/2015
			APEXXX
			Various Distributors
			n/a
			ebay.com
			Undeclared sildenafil
			Public Notification
			Drugs10/23/2015
			Ultra SX Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs10/23/2015
			Super Dragon 6000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs10/23/2015
			Paradise Suplemento Natural Ultra Plus Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs10/23/2015
			Basha Nut 100% Fruit Soft Gel Capsules
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs10/09/2015
			Rhino 7 3000
			TF Supplements
			6666 Gulf Freeway, Houston, TX
			International Mail Shipments
			Undeclared desmethyl carbondenafil and dapoxetine
			Recall
			Drugs10/09/2015
			Rhino 7 Platinum 3000
			TF Supplements
			6666 Gulf Freeway, Houston, TX
			International Mail Shipments
			Undeclared desmethyl carbondenafil and dapoxetine
			Recall
			Drugs10/01/2015
			NATUREAL
			Various Distributors
			n/a
			naturealfs.com
			Undeclared sibutramine
			Public Notification
			Drugs10/01/2015
			Ultimate Herbal Slimcap
			Various Distributors
			n/a
			fitfirmandfabulous.com
			Undeclared sibutramine
			Public Notification
			Drugs09/23/2015
			Shorts on the Beach Blue and Gold Edition
			Lucy's Weight Loss System
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Recall
			Drugs09/23/2015
			Pink Bikini
			Lucy's Weight Loss System
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Recall
			Drugs09/11/2015
			Miracle Diet 30
			The One Minute Miracle Inc.
			3322 NE 166 Street, North Miami Beach, FL 33160
			n/a
			Undeclared phenolphthalein
			Recall
			Drugs
			Warning Letter09/11/2015
			Miracle Diet 48
			The One Minute Miracle Inc.
			3322 NE 166 Street, North Miami Beach, FL 33160
			n/a
			Undeclared thiosildenafil
			Recall
			Drugs
			Warning Letter09/04/2015
			Vimax
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared tadalafil
			Public Notification
			Drugs09/04/2015
			Meizi Super Power Fruits Herbal Slimming Formula
			Various Distributors
			n/a
			slimeast.com
			Undeclared sibutramine
			Public Notification
			Drugs08/06/2015
			Kaboom Actions Strip 12 Pack
			Blue Square Market Inc.
			North Huntingdon, PA
			calcompnutrition.com
			Undeclared sulfoaildenafil
			Recall
			Drugs08/06/2015
			LiDa DaiDaiHua
			Blue Square Market Inc.
			North Huntingdon, PA
			calcompnutriton.com
			Undeclared sibutramine and phenolphthalein
			Recall
			Drugs08/06/2015
			Achieving Zero
			Various Distributors
			n/a
			amazon.com
			Undeclared sibutramine
			Public Notification
			Drugs07/02/2015
			Akttive Capsules
			Life & More, L.L.C.
			Miami, FL
			akttive.com
			Undeclared sibutramine, desmethylsibutramine, and phenolphthalein
			Public Notification
			Drugs
			Recall07/02/2015
			Zero Xtreme
			Fat Burners Zone
			n/a
			zeroxtremeusa.com
			Undeclared sibutramine and desmethylsibutramine
			Public Notification
			Drugs
			Recall06/12/2015
			Pyrola
			G&C Natural Nutrition, Inc,
			Fullerton, CA
			N/A
			Undeclared diclofenac
			Recall
			Drugs06/05/2015
			Pyrola Advanced Joint Formula
			Various Distributors
			n/a
			amazon.com
			Undeclared diclofenac
			Public Notification
			Drugs06/03/2015
			Smart Lipo
			SmartLipo365 and Centro Naturista
			2915 East Division Street, Suite 523, Arlington, TX76011
			smartlipo365.com
			Undeclared sibutramine, desmethylsibutramine, and phenolphthalein
			Recall
			Drugs
			Expanded Recall

			Warning Letter05/12/2015
			Slim Xtreme Diamond
			Globe All Wellness
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs05/12/2015
			Slim Xtreme Platinum
			Globe All Wellness
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs05/04/2015
			Jianbu Huqian Wan
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared dexamethasone,  chlorpheniramine, and furosemide
			Public Notification
			Drugs05/04/2015
			Saurean Fong Sep Lin
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared dexamethasone and cyproheptadine
			Public Notification
			Drugs05/04/2015
			Asihuri Plus Forte
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared dexamethasone and phenylbutazone
			Public Notification
			Drugs05/04/2015
			Ginseng She Lian Wan
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared dexamethasone and chlorpheniramine
			Public Notification
			Drugs04/30/2015
			King of Romance
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs04/30/2015
			Viagra 007
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs04/30/2015
			Slim Forte Slimming Capsule
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs04/30/2015
			Li Da Dai Dai Hua Slimming Capsule
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs04/30/2015
			Black Panther
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs04/29/2015
			Fatloss Slimming Beauty
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs04/29/2015
			Superior
			Various Distributors
			n/a
			detoxtheweightaway.com; beeallnatural.net
			Undeclared sibutramine
			Public Notification
			Drugs04/21/2015
			Extreme Diamond 3000
			Various Distributors
			n/a
			libidoshops.com
			Undeclared desmethyl carbodenafil and dapoxetine
			Public Notification
			Drugs03/26/2015
			Green Algae Combination
			Crane Beauty
			n/a
			International Mail Shipments
			Undeclared lorcaserin
			Public Notification
			Drugs03/18/2015
			Xcel Advanced
			Various Distributors
			n/a
			beenaturalnutrition.com
			Undeclared phenolphthalein
			Public Notification
			Drugs03/18/2015
			Ultimate Boost
			Various Distributors
			n/a
			sportnutrition1.com
			Undeclared phenolphthalein
			Public Notification
			Drugs03/18/2015
			Xcel
			Various Distributors
			n/a
			zixiutangforyourfigure.com
			Undeclared fluoxetine
			Public Notification
			Drugs03/18/2015
			Xcel Advanced
			Various Distributors
			n/a
			beenaturalnutrition.com
			Undeclared phenolphthalein
			Public Notification
			Drugs03/10/2015
			UltraZx
			UltraZx, Labs, L.L.C.
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Recall
			Drugs03/05/2015
			Black Mamba Premium
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/05/2015
			Black Mamba Hyperrush
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs03/05/2015
			African Superman
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/05/2015
			L-Carnitine Sob Strengthening Version Slimming Miracle Capsule
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs03/05/2015
			Black Ant King
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/05/2015
			Bigger Longer More Time More Sperms
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/03/2015
			Herb Viagra
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/03/2015
			Natural Max Slimming
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil, fluoxetine and sibutramine
			Public Notification
			Drugs03/03/2015
			Diablos Eca Fire Caps
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil, phenolphthalein, sibutramine and an analogue of sibutramine, deisobutylbenzylsibutramine
			Public Notification
			Drugs03/03/2015
			Stiff Nights
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/03/2015
			Male Silkworm Moth Nourishing Oral Liquid
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared vardenafil
			Public Notification
			Drugs03/03/2015
			Baolong
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/03/2015
			Rhino Blitz Gold 3000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/03/2015
			Vim-25
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/02/2015
			MME MAXMAN
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/02/2015
			FX3000
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/02/2015
			Hard Wang
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/02/2015
			Vigour 300
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/02/2015
			Santi Scalper
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/02/2015
			Plant Vigra
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/02/2015
			Vigra
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/02/2015
			Elimulating Weight & Toxin Keeping Beauty
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine
			Public Notification
			Drugs03/02/2015
			Super Hard
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs03/02/2015
			Sex Men
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs02/28/2015
			Seven Slim
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared phenolphthalein
			Public Notification
			Drugs02/28/2015
			Night Man
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs02/28/2015
			Libigrow XXX Treme
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs02/28/2015
			Nine Slim
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared phenolphthalein
			Public Notification
			Drugs02/28/2015
			Oxy ELITE Pro Super Thermogenic
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared fluoxetine
			Public Notification
			Drugs02/27/2015
			72HP
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs02/27/2015
			Tibet Babao
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs02/27/2015
			Germany Niubian
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sildenafil
			Public Notification
			Drugs02/27/2015
			Botanical Slimming (Red)
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared fluoxetine
			Public Notification
			Drugs02/25/2015
			Lean Body Extreme
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared sibutramine, desmethyl sibutramine, phenolphthalein, and sildenafil
			Public Notification
			Drugs02/09/2015
			BtRim Max
			Detox Transforms Health and Nutrition
			Garner, NC
			n/a
			Undeclared phenolphthalein
			Recall
			Drugs02/09/2015
			AMPD Gold Bee Pollen
			Detox Transforms Health and Nutrition
			Garner, NC
			n/a
			Undeclared sildenafil
			Recall
			Drugs02/09/2015
			iNDiGO
			Detox Transforms Health and Nutrition
			Garner, NC
			n/a
			Undeclared phenolphthalein
			Recall
			Drugs02/09/2015
			EDGE Amplified Weight Release
			Detox Transforms Health and Nutrition
			Garner, NC
			n/a
			Undeclared phenolphthalein and fluoxetine
			Recall
			Drugs02/09/2015
			iNSANE Bee Pollen
			Detox Transforms Health and Nutrition
			Garner, NC
			n/a
			Undeclared phenolphthalein and fluoxetine
			Recall
			Drugs02/03/2015
			Yanhee Slim
			Various Distributors
			n/a
			n/a
			Undeclared lorcaserin
			Public Notification
			Drugs01/21/2015
			Happy Passengers
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs12/23/2014
			Zhansheng Weige Chaoyue Xilishi
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs12/23/2014
			Triple PowerZen
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs12/23/2014
			Samurai-X
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs12/23/2014
			Slim-K
			Bethel Nutritional Consulting, Inc.
			New York, NY
			bethel30.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs
			Recall12/19/2014
			B-Lipo
			Bethel Nutritional Consulting, Inc.
			New York, NY
			bethel30.com
			Undeclared lorcaserin
			Recall
			Drugs11/25/2014
			Slim Vie
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs11/25/2014
			Bee Thin
			Various Distributors
			n/a
			beethinzxt.com
			Undeclared sibutramine
			Public Notification
			Drugs11/24/2014
			Super Extreme Accelerator
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs11/24/2014
			Bee Slim
			Various Distributors
			n/a
			International Mail Shipments
			Undeclared
			Public Notification
			Drugs11/24/2014
			Black Storm
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs11/20/2014
			Feng Shi Ling by Hong Kong Chi Chun Tang Herbal Factory
			Various Distributors
			n/a
			n/a
			Undeclared diclofenac and indomethacin
			Public Notification
			Drugs11/19/2014
			Forever Beautiful Bee Pollen
			REFA Enterprises, LLC
			n/a
			n/a
			Undeclared sibutramine and/or phenolphthalein
			Recall
			Drugs11/19/2014
			Forever Beautiful Infinity
			REFA Enterprises, LLC
			n/a
			n/a
			Undeclared sibutramine and/or phenolphthalein
			Recall
			Drugs11/14/2014
			Mayhem
			Chaotic-Labz
			Atkins, AR
			n/a
			Undeclared dexamethasone
			Recall
			Drugs11/04/2014
			V26 Slimming Coffee
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/30/2014
			Ginseng Kianpi Pil
			Kweilin Drug Manufactory
			n/a
			ginsengkianpipil.com
			Undeclared dexamethasone
			Public Notification
			Drugs10/10/2014
			Sit and Slim II
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs09/26/2014
			Mojo Risen
			Nova Products, Inc.
			5 Mount Pleasant Road, Aston, PA 19014
			n/a
			Undeclared sildenafil
			Warning Letter
			Drugs09/26/2014
			XZone 1200
			Nova Products, Inc.
			5 Mount Pleasant Road, Aston, PA 19014
			n/a
			Undeclared sildenafil and tadalafil
			Warning Letter
			Drugs09/26/2014
			XZone Gold
			Nova Products, Inc.
			5 Mount Pleasant Road, Aston, PA 19014
			n/a
			Undeclared sildenafil and tadalafil
			Warning Letter
			Drugs09/26/2014
			XZen 1200
			Nova Products, Inc.
			5 Mount Pleasant Road, Aston, PA 19014
			n/a
			Undeclared sildenafil and tadalafil
			Warning Letter
			Drugs09/26/2014
			XZen Platinum
			Nova Products, Inc.
			5 Mount Pleasant Road, Aston, PA 19014
			n/a
			Undeclared sildenafil and tadalafil
			Warning Letter
			Drugs09/26/2014
			Black Ant
			Nova Products, Inc.
			5 Mount Pleasant Road, Aston, PA 19014
			n/a
			Undeclared sildenafil
			Warning Letter
			Drugs09/26/2014
			African Black Ant
			Nova Products, Inc.
			5 Mount Pleasant Road, Aston, PA 19014
			n/a
			Undeclared sildenafil
			Warning Letter
			Drugs09/26/2014
			XZen Gold
			Nova Products, Inc.
			5 Mount Pleasant Road, Aston, PA 19014
			n/a
			Undeclared sildenafil and tadalafil
			Warning Letter
			Drugs09/12/2014
			LX1
			Various Distributors
			n/a
			drskinsecret.com
			Undeclared DMAA
			Public Notification
			Foods09/12/2014
			Best Line Suplemento Alimenticio Capsules
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs09/12/2014
			Mezo
			Various Distributors
			n/a
			n/a
			Undeclared benzylsibutramine
			Public Notification
			Drugs08/11/2014
			Arize
			Various Distributors
			n/a
			calcompnutrition.com
			Undeclared sulfoaildenafil
			Public Notification
			Drugs08/11/2014
			Herbal Vigor Quick Fix
			Various Distributors
			n/a
			calcompnutrition.com
			Undeclared tadalafil
			Public Notification
			Drugs07/22/2014
			O.M.G
			Various Distributors
			n/a
			sears.com
			Undeclared sildenafil
			Public Notification
			Drugs07/08/2014
			Mix Fruit Slimming
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs07/08/2014
			Lipo 8 Burn Slim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs07/08/2014
			24 Ince
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs07/08/2014
			Sliming Diet By Pretty White
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs07/08/2014
			Lingzhi Cleansed Slim Tea
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs07/08/2014
			Trim-Fast Slimming Softgel
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs06/17/2014
			Miraculous Evil Root
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs06/17/2014
			Toxin Discharged Tea
			Various Distributors
			n/a
			n/a
			Undeclared fluoxetine
			Public Notification
			Drugs06/17/2014
			Sport Burner
			Various Distributors
			n/a
			n/a
			Undeclared fluoxetine
			Public Notification
			Drugs06/17/2014
			Gold Vigra
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs06/17/2014
			Sliming Diet
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs06/10/2014
			La Jiao Shou Shen
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs06/05/2014
			B-Perfect
			Various Distributors
			n/a
			icanb-perfect.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs06/05/2014
			Zhen Gong Fu
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs06/02/2014
			Eyeful
			Various Distributors
			n/a
			n/a
			Undeclared hydroxythiohomosildenafil
			Public Notification
			Drugs06/02/2014
			3 Hard Knights
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and thiosildenafi
			Public Notification
			Drugs06/02/2014
			Liu Bian Li
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs06/02/2014
			Full Throttle On Demand
			Various Distributors
			n/a
			overstock.com
			Undeclared propoxyphenyl sildenafil
			Public Notification
			Drugs06/02/2014
			Dick's Hard Up
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs06/02/2014
			GoldReallas
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and thiosildenafi
			Public Notification
			Drugs05/16/2014
			MV 5 Days
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs05/16/2014
			Asset Bold
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs05/12/2014
			Asset Bee Pollen
			Various Distributors
			n/a
			assetcapsules4u.com
			Undeclared sibutramine
			Public Notification
			Drugs05/05/2014
			Natural Body Solution
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs05/05/2014
			Slim Trim U
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs04/21/2014
			Super Arthgold
			Nano Well-being Health Inc.
			La Mirada, CA
			n/a
			Undeclared chlorzoxazone, diclofenac and indomethacin
			Recall
			Drugs04/16/2014
			S.W.A.G
			Various Distributors
			n/a
			sexwithagrudge.com
			Undeclared sildenafil
			Public Notification
			Drugs04/10/2014
			Lite Fit USA
			Various Distributors
			n/a
			herbsultimate.com
			Undeclared sibutramine
			Public Notification
			Drugs04/10/2014
			Infinity
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs04/09/2014
			Thinogenics
			Nature’s Universe
			n/a
			shopnaturesuniverse.com; easy2loseweight.com
			Undeclared sibutramine
			Recall
			Drugs04/02/2014
			New You
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs03/26/2014
			Bella Vi Insane Bee Pollen Capsules
			Pure Edge Nutrition, LLC
			Toms River, NJ
			n/a
			Undeclared sibutramine and/or phenophthalein
			Recall
			Drugs03/26/2014
			Bella Vi BTrim Ultimate Boost
			Pure Edge Nutrition, LLC
			Toms River, NJ
			n/a
			Undeclared sibutramine and/or phenophthalein
			Recall
			Drugs03/26/2014
			Bella Vi BTrim Max
			Pure Edge Nutrition, LLC
			Toms River, NJ
			n/a
			Undeclared sibutramine and/or phenophthalein
			Recall
			Drugs03/26/2014
			Bella Vi Extreme Accelerator
			Pure Edge Nutrition, LLC
			Toms River, NJ
			n/a
			Undeclared sibutramine and/or phenophthalein
			Recall
			Drugs03/26/2014
			Bella Vi Insane Amp’d
			Pure Edge Nutrition, LLC
			Toms River, NJ
			n/a
			Undeclared sibutramine and/or phenophthalein
			Recall
			Drugs03/26/2014
			Bella Vi Amp’d Up
			Pure Edge Nutrition, LLC
			Toms River, NJ
			n/a
			Undeclared sibutramine and/or phenophthalein
			Recall
			Drugs03/26/2014
			Super Fat Burner
			New Life Nutritional Center
			n/a
			n/a
			Undeclared sibutramine and/or phenophthalein
			Recall
			Drugs03/26/2014
			Maxi Gold
			New Life Nutritional Center
			n/a
			n/a
			Undeclared sibutramine and/or phenophthalein
			Recall
			Drugs03/26/2014
			Esmeralda
			New Life Nutritional Center
			n/a
			n/a
			Undeclared sibutramine and/or phenophthalein
			Recall
			Drugs03/19/2014
			Vitaccino Coffee
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs03/07/2014
			Weekend Warrior
			Various Distributors
			n/a
			onlinecoralcalcium.com
			Undeclared thiosildenafil
			Public Notification
			Drugs02/13/2014
			Arth-Q, “알쓰큐” or “알쓰Q"
			Various Distributors
			n/a
			kaymall.com
			Undeclared ibuprofen
			Public Notification
			Drugs02/04/2014
			Magic Slim
			MyNicNaxs, Inc.
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sibutramine, N-desmethylsibutramine and benzylsibutramine
			Recall
			Drugs
			Warning Letter

			Additional Recall

			Consent Decree02/04/2014
			Fruta Bio
			MyNicNaxs, Inc.
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sibutramine and phenolphthalein
			Recall
			Drugs
			Warning Letter

			Additional Recall

			Consent Decree02/04/2014
			SlimEasy
			MyNicNaxs, Inc.
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sibutramine and N-desmethylsibutramine
			Recall
			Drugs
			Warning Letter

			Additional Recall

			Consent Decree02/04/2014
			Super Fat Burning Bomb
			MyNicNaxs, Inc.
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared N-desthylsibutraminea nd phenolphthalein
			Recall
			Drugs
			Warning Letter

			Additional Recall

			Consent Decree02/04/2014
			Slim Xtreme
			MyNicNaxs, Inc.
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sibutramine, N-desmethylsibutramine and benzylsibutramine
			Recall
			Drugs
			Warning Letter

			Additional Recall

			Consent Decree02/04/2014
			Meizi Evolution
			MyNicNaxs, Inc.
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sibutramine, N-desmethylsibutramine and benzylsibutramine
			Recall
			Drugs
			Warning Letter

			Additional Recall

			Consent Decree02/04/2014
			Meizitang Strong Version Botanical Slimming
			MyNicNaxs, Inc.
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared sibutramine, N-desmethylsibutramine and benzylsibutramine
			Recall
			Drugs
			Warning Letter

			Additional Recall

			Consent Decree02/04/2014
			Jianfeijindan Activity Girl
			MyNicNaxs, Inc.
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared N-di-desmethylsibutramine
			Recall
			Drugs
			Warning Letter

			Additional Recall

			Consent Decree02/04/2014
			Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill
			MyNicNaxs, Inc.
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared phenolphthalein
			Recall
			Drugs
			Warning Letter

			Additional Recall

			Consent Decree02/04/2014
			Reduce Weight Fruta Planta
			MyNicNaxs, Inc.
			1012 Alpine Dr, Deltona, FL 32725
			mynicnaxs.com; ruglamourous.com
			Undeclared phenolphthalein
			Recall
			Drugs
			Warning Letter

			Additional Recall

			Consent Decree01/28/2014
			Bali Mojo
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs01/28/2014
			Hot Detox
			Various Distributors
			n/a
			hotdetoxllc.com
			Undeclared sibutramine
			Public Notification
			Drugs01/28/2014
			Citrus Fit Gold
			Citrus Fit Weight Loss and Detox Products, LLC
			n/a
			citrusfit.com
			Undeclared sibutramine
			Public Notification
			Drugs
			Warning Letter01/28/2014
			JINQIANGBUDOR Red Dragon
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs01/28/2014
			Tiger King
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs01/28/2014
			SexRx
			Various Distributors
			n/a
			alternative-health-supplements.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs01/28/2014
			Tonic Life BP
			Various Distributors
			n/a
			tonic-life-products.com
			Undeclared phenolphthalein
			Public Notification
			Drugs01/21/2014
			Dream Body Slimming Capsule
			Slim Beauty USA
			503 E. 23rd St.
			Kearney, NE 68847
			slimbeautyusa.com
			Undeclared sibutramine
			Public Notification
			Drugs
			Warning Letter01/21/2014
			Magic Slim
			Slim Beauty USA
			503 E. 23rd St.
			Kearney, NE 68847
			slimbeautyusa.com
			Undeclared sibutramine
			Public Notification
			Drugs
			Warning Letter01/15/2014
			Pro ArthMax
			Various Distributors
			n/a
			n/a
			Undeclared diclofenac, ibuprofen, naproxen, indomethacin, nefopam, and chlorzoxazone
			Public Notification
			Drugs01/09/2014
			Magic for Men
			Midwest Wholesale
			Nixa, MO
			n/a
			Undeclared sildenafil and/or tadalafil
			Recall
			Drugs01/09/2014
			Boost Ultra
			Midwest Wholesale
			Nixa, MO
			n/a
			Undeclared sildenafil and/or tadalafil
			Recall
			Drugs01/09/2014
			XZone Gold
			Midwest Wholesale
			Nixa, MO
			n/a
			Undeclared sildenafil and/or tadalafil
			Recall
			Drugs01/09/2014
			Sexy Monkey
			Midwest Wholesale
			Nixa, MO
			n/a
			Undeclared sildenafil and/or tadalafil
			Recall
			Drugs01/09/2014
			Triple MiracleZen Platinum
			Midwest Wholesale
			Nixa, MO
			n/a
			Undeclared sildenafil and/or tadalafil
			Recall
			Drugs01/09/2014
			"New" Extenze
			Midwest Wholesale
			Nixa, MO
			n/a
			Undeclared sildenafil and/or tadalafil
			Recall
			Drugs01/09/2014
			New XZen Platinum
			Midwest Wholesale
			Nixa, MO
			n/a
			Undeclared sildenafil and/or tadalafil
			Recall
			Drugs12/23/2013
			Burn 7
			Deseo Rebajar Inc.
			n/a
			deseorebajar.com
			Undeclared phenolphthalein
			Public Notification
			Drugs
			Recall12/23/2013
			Mass Destruction
			Blunt Force Nutrition
			n/a
			n/a
			Labeled to contain at least one synthetic anabolic steroid
			Press Release
			Drugs12/19/2013
			SlimEasy Herbs Capsule
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs12/19/2013
			CONTROL All Natural Sexual Enhancement
			Various Distributors
			n/a
			n/a
			Undeclared sulfoaildenafil and dimethylsildenafil
			Public Notification
			Drugs12/19/2013
			Asset Extreme Plus
			Various Distributors
			n/a
			allnaturalbeelievers.com
			Undeclared sibutramine
			Public Notification
			Drugs12/19/2013
			Best Whips
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs12/19/2013
			Asset Extreme
			Various Distributors
			n/a
			assetcapsules4u.com
			Undeclared sibutramine
			Public Notification
			Drugs12/19/2013
			7 Days Herbal Slim
			Various Distributors
			n/a
			suncoastspaequipment.com
			Undeclared sibutramine
			Public Notification
			Drugs12/19/2013
			Dr. Ming's Chinese Capsule
			Various Distributors
			n/a
			slimbeautyusa.com
			Undeclared sibutramine
			Public Notification
			Drugs
			Warning Letter12/19/2013
			Sliming Diet Berry Plus
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs12/19/2013
			Meizitang Citrus
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs11/29/2013
			Hydravax
			IQ Formulations
			Sunrise, FL
			n/a
			Undeclared diuretic
			Recall
			Drugs11/21/2013
			Alpha Male
			Various Distributors
			n/a
			n/a
			Undeclared aminotadalafil, sulfosildenafil, sulfoaildenafil, hydroxythiohomosildenafil, dimethylsildenafil, and sildenafil
			Public Notification
			Drugs11/21/2013
			SlimExtra Herbal Capsules
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs11/21/2013
			Body Beauty 5 Days Slimming Coffee
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs11/21/2013
			Diet Master
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs11/21/2013
			Super Slim
			Various Distributors
			n/a
			bonanza.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs11/20/2013
			Slim Max
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs11/19/2013
			P-Boost
			Tendex
			Los Angeles, CA
			n/a
			Undeclared tadalafil
			Recall
			Drugs11/19/2013
			NatuRECT
			Tendex
			Los Angeles, CA
			n/a
			Undeclared tadalafil
			Recall
			Drugs11/18/2013
			RezzRX
			Fossil Fuel Products, LLC
			n/a
			n/a
			Undeclared hydroxylthiohomosildenafil and aminotadalafil
			Recall
			Drugs11/16/2013
			Rhino 5 Plus
			Jobbers Wholesale
			Paramount, CA
			n/a
			Undeclared desmethylcarbondenafil and dapoxetine
			Recall
			Drugs11/16/2013
			Maxtremezen
			Jobbers Wholesale
			Paramount, CA
			n/a
			Undeclared desmethylcarbondenafil and dapoxetine
			Recall
			Drugs11/16/2013
			Extenzone
			Various Distributors
			Paramount, CA
			n/a
			Undeclared desmethylcarbondenafil and dapoxetine
			Recall
			Drugs11/14/2013
			Adipotrim XT
			Deseo Rebajar Inc.
			n/a
			deseorebajar.com
			Undeclared fluoxetine
			Recall
			Drugs11/08/2013
			Vitalikor Fast Acting
			Various Distributors
			n/a
			vitalityreseasrchlabs.com; vitalikor.com; gnc.com
			Undeclared tadalafil and vardenafil
			Public Notification
			Drugs11/07/2013
			Jimpness Beauty Fat Loss Capsules
			Various Distributors
			n/a
			jimpness.net
			Undeclared ramine, phenolphthalein, and sildenafil
			Public Notification
			Drugs11/05/2013
			Goodliness Fat-Reducing Capsules
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs10/10/2013
			Be Inspired
			Various Distributors
			n/a
			beinspirednaturally.com
			Undeclared sibutramine
			Public Notification
			Drugs10/10/2013
			Dr. Mao Slimming Capsules
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/10/2013
			Perfect Body Solutions
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/10/2013
			Bella Vi Insane Amp’d
			Various Distributors
			n/a
			pureedgenutrition.com; newedgenutrition.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs10/10/2013
			Bella Vi Amp’d Up
			Various Distributors
			n/a
			pureedgenutrition.com; newedgenutrition.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs10/07/2013
			Lidiy
			B@B Trade, Inc
			FL
			lidiy.com
			Undeclared sibutramine
			Recall
			Drugs10/07/2013
			Slim Fortune
			B@B Trade, Inc
			FL
			slimfortune.com
			Undeclared sibutramine
			Recall
			Drugs10/07/2013
			Slim Expert
			B@B Trade, Inc
			FL
			slimexpert.com
			Undeclared sibutramine
			Recall
			Drugs09/24/2013
			Virilis Pro
			Haute Health, LLC
			Williamstown, NJ
			virilispro.com
			Undeclared sildenafil
			Recall
			Drugs09/24/2013
			PHUK
			Haute Health, LLC
			Williamstown, NJ
			virilispro.com
			Undeclared sildenafil
			Recall
			Drugs09/24/2013
			Prolifta
			Haute Health, LLC
			Williamstown, NJ
			virilispro.com
			Undeclared sildenafil
			Recall
			Drugs09/24/2013
			XZen Xpress
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs09/24/2013
			XZen 1200
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs09/24/2013
			XZone Premium
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil, tadalafil, and dapoxetine
			Public Notification
			Drugs09/24/2013
			Xzen Gold
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs09/24/2013
			Wood-E
			Various Distributors
			n/a
			netnutri.com
			Undeclared sildenafil
			Public Notification
			Drugs09/24/2013
			Instant Slim, 收腹提臀果香型减肥胶囊, Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang, or Сокращать живот и повышать 3ад
			Various Distributors
			n/a
			instantslim.org
			Undeclared sibutramine
			Public Notification
			Drugs08/27/2013
			Pro Power Max
			Hardmenstore.com
			Fort Lauderdale, FL
			n/a
			Undeclared sildenafil
			Recall
			Drugs08/27/2013
			Evil Root
			Hardmenstore.com
			Fort Lauderdale, FL
			n/a
			Undeclared sildenafil
			Recall
			Drugs08/27/2013
			72HP
			Hardmenstore.com
			Fort Lauderdale, FL
			n/a
			Undeclared sildenafil
			Recall
			Drugs08/22/2013
			Ortiga
			Various Distributors
			n/a
			ebay.com
			Undeclared diclofenac
			Public Notification
			Drugs08/07/2013
			Tranquility
			Health and Beyond, LLC
			Boca Raton, FL
			n/a
			Undeclared doxepin and chlorpormazine
			Recall
			Drugs08/05/2013
			Quick Thin
			Bethel Nutritional Consulting, Inc.
			New York, NY
			bethel30.com
			Undeclared sibutramine and phenolphthalein
			Recall
			Drugs08/05/2013
			Bethel Advance
			Bethel Nutritional Consulting, Inc.
			New York, NY
			bethel30.com
			Undeclared sibutramine and phenolphthalein
			Recall
			Drugs07/19/2013
			Esbelin siloutte te
			Herbal Give Care LLC
			Grand Prairie, TX
			n/a
			Undeclared Ssbutramine, N-desmethylsibutramine, and N-di-desmethylsibutramine
			Recall
			Drugs07/19/2013
			Esbelin siloutte Herbal Blend with L-Carnitine
			Herbal Give Care LLC
			Grand Prairie, TX
			n/a
			Undeclared Ssbutramine, N-desmethylsibutramine, and N-di-desmethylsibutramine
			Recall
			Drugs07/18/2013
			Volcano Male Enhancement Liquid
			Volcano Company
			Long Beach, CA
			n/a
			Undeclared desmethyl carbodenafil, dimethylsildenafil, and dapoxetine
			Recall
			Drugs07/18/2013
			Volcano Male Enhancement Capsules
			Volcano Company
			Long Beach, CA
			n/a
			Undeclared desmethyl carbodenafil and dapoxetine
			Recall
			Drugs06/28/2013
			Clalis
			Various Distributors
			n/a
			hardmenstore.com
			Undeclared sildenafil
			Public Notification
			Drugs06/28/2013
			MaxTreme Zen
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs06/28/2013
			Exten 1300
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs06/28/2013
			MVP Mega
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs06/27/2013
			Meizi Evolution
			Various Distributors
			n/a
			ebay.com
			Undeclared sibutramine
			Public Notification
			Drugs06/27/2013
			Strawberry Balance
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs06/27/2013
			Silver Sword
			Various Distributors
			n/a
			hardmenstore.com
			Undeclared sildenafil
			Public Notification
			Drugs06/18/2013
			Fat Zero
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs06/18/2013
			Fruit & Plant Slimming
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs06/18/2013
			Royal Dragon Herbal Tonic Balls
			Various Distributors
			n/a
			n/a
			Undeclared vardenafil
			Public Notification
			Drugs06/18/2013
			Extreme Body Slim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs06/18/2013
			Paiyouji Plus
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs06/10/2013
			Get It Up
			Various Distributors
			n/a
			ebay.com
			Undeclared sildenafil
			Public Notification
			Drugs06/10/2013
			Super Cheetah
			Various Distributors
			n/a
			bonanza.com
			Undeclared sildenafil
			Public Notification
			Drugs06/10/2013
			XIYOUJI QINGZHI CAPSULE
			Various Distributors
			n/a
			jadera.net
			Undeclared sibutramine
			Public Notification
			Drugs06/10/2013
			X Zen Platinum
			Various Distributors
			n/a
			ebay.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs06/10/2013
			Nights to Remember
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs06/10/2013
			Cave Diver
			Various Distributors
			n/a
			bonanza.com
			Undeclared sildenafil
			Public Notification
			Drugs06/10/2013
			Reload
			Various Distributors
			n/a
			reloadpill.com
			Undeclared sildenafil
			Public Notification
			Drugs06/10/2013
			Bethel 30
			Bethel Nutritional Consulting, Inc.
			New York, NY
			bethel30.com
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall

			Expanded Recall06/10/2013
			Mojo Risen
			Various Distributors
			n/a
			ebay.com
			Undeclared noracetildenafil
			Public Notification
			Drugs05/07/2013
			SexVoltz
			BeaMonstar Products
			Queen Creek, AZ
			n/a
			Undeclared tadalafil
			Recall
			Drugs
			Expanded Recall05/07/2013
			Velextra
			BeaMonstar Products
			Queen Creek, AZ
			n/a
			Undeclared tadalafil
			Recall
			Drugs05/07/2013
			Amerect
			BeaMonstar Products
			Queen Creek, AZ
			n/a
			Undeclared tadalafil
			Recall
			Drugs05/07/2013
			Lightning Rod
			Chang Kwung
			n/a
			n/a
			Undeclared analogue of sildenafil
			Recall
			Drugs05/07/2013
			Bullet Proof
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs05/01/2013
			Vicerex
			American Lifestyle
			640 Kreag Road, Pittsford, NY 14534
			n/a
			Undeclared tadalafil
			Recall
			Drugs05/01/2013
			Black Ant
			American Lifestyle
			640 Kreag Road, Pittsford, NY 14534
			n/a
			Undeclared sildenafil
			Recall
			Drugs04/25/2013
			Zoom-Zooma-Zoom
			Amrutam Life Care Pvt. Ltd.
			India
			amrutamlifecare.com
			Undeclared sildenafil
			Public Notification
			Drugs
			Warning Letter04/25/2013
			Sex Plus
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil, tadalafil, sulfosildenafil and dimethylacetildenafil
			Public Notification
			Drugs04/11/2013
			Affirm XL
			Affirm XL, Inc
			n/a
			n/a
			Undeclared analogue of sildenafil
			Recall
			Drugs04/04/2013
			MAXILOSS Weight Advanced Blue
			Various Distributors
			n/a
			extremevitaminworld.com; dreamlifeweightloss.com
			Undeclared sibutramine
			Public Notification
			Drugs04/03/2013
			Love Rider
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs04/03/2013
			Ninja Mojo
			Various Distributors
			n/a
			n/a
			Undeclared tadalafil
			Public Notification
			Drugs03/21/2013
			Stiff Days
			Various Distributors
			n/a
			stiffdays.com
			Undeclared sildenafil
			Public Notification
			Drugs03/21/2013
			Libido Sexual Enhancer
			Various Distributors
			n/a
			vegasredpleasure.com
			Undeclared hydroxythiohomosildenafil, hydroxyhomosildenafil, sildenafil, and tadalafil
			Public Notification
			Drugs03/12/2013
			Night Bullet
			Green Planet, Inc.
			Riverside, CA
			n/a
			Undeclared sulfohydroxyhomosildenafil and aminotadalafil
			Recall
			Drugs01/24/2013
			Super Power
			D&S Herbals, LLC, d/b/a Freedom Trading
			Woodbridge, NJ
			n/a
			Undeclared sildenafil
			Recall
			Drugs01/08/2013
			MAXILOSS Weight Advanced
			Various Distributors
			n/a
			dreamlifeweightloss.com
			Undeclared sibutramine
			Public Notification
			Drugs12/19/2012
			WOW
			Riger Naturals S.A.
			n/a
			gonepainfree.com; browerent.com; refumofanusa.com
			Undeclared dexamethasone, diclofenac sodium and methocrabamol
			Public Notification
			Drugs
			Consumer Update12/19/2012
			Slimdia Revolution
			P&J Trading
			n/a
			pinkfatty.com
			Undeclared sibutramine
			Recall
			Drugs
			Public Notification12/17/2012
			Libigrow XXX
			Performance Plus Marketing, Inc.
			CA
			n/a
			Undeclared sulfoaildenafil and thioaidenafil
			Recall
			Drugs12/17/2012
			Casanova
			Performance Plus Marketing, Inc
			CA
			n/a
			Undeclared sulfoaildenafil and thioaidenafil
			Recall
			Drugs12/17/2012
			Mojo Nights
			Performance Plus Marketing, Inc
			CA
			n/a
			Undeclared sulfoaildenafil and thioaidenafil
			Recall
			Drugs12/17/2012
			Mojo Nights Supreme
			Performance Plus Marketing, Inc
			CA
			n/a
			Undeclared sulfoaildenafil and thioaidenafil
			Recall
			Drugs12/17/2012
			Blue Diamond Platinum
			Performance Plus Marketing, Inc
			CA
			n/a
			Undeclared sulfoaildenafil and thioaidenafil
			Recall
			Drugs12/17/2012
			Libigrow
			Performance Plus Marketing, Inc
			CA
			n/a
			Undeclared sulfoaildenafil and thioaidenafil
			Recall
			Drugs12/17/2012
			Blue Diamond
			Performance Plus Marketing, Inc
			CA
			n/a
			Undeclared sulfoaildenafil and thioaidenafil
			Recall
			Drugs11/08/2012
			Best Share Green Coffee: Brazilian Slimming Coffee
			Various Distributors
			n/a
			houseofmonet.com
			Undeclared sibutramine
			Public Notification
			Drugs11/08/2012
			Beautiful Slim Body
			Various Distributors
			n/a
			houseofmonet.com
			Undeclared sibutramine
			Public Notification
			Drugs11/08/2012
			Japan Hokkaido Slimming Weight Loss Pills
			Various Distributors
			n/a
			ebay.com
			Undeclared sibutramine
			Public Notification
			Drugs10/24/2012
			Classic Zi Xiu Tang Bee Pollen
			Zi Xiu Tang Success, LLC
			Trexlertown, PA
			n/a
			Undeclared sibutramine
			Recall
			Drugs10/24/2012
			Ultimate Formula Capsules
			Zi Xiu Tang Success, LLC
			Trexlertown, PA
			n/a
			Undeclared sibutramine
			Recall
			Drugs10/04/2012
			Tianji True Slim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs09/12/2012
			ACTRA-Sx 500
			Body Basics Inc.
			n/a
			n/a
			Undeclared sildenafil
			Recall
			Drugs08/23/2012
			Mojo Nights
			Evol Nutrition Associates, Inc./Red Dawn
			Kennesaw, GA
			n/a
			Undeclared tadalafil and sildenafil
			Recall
			Drugs08/21/2012
			Reumofan Plus Premium
			Riger Naturals S.A.
			n/a
			n/a
			Undeclared diclofenac sodium and methocarbamol
			News Release
			Drugs
			Consumer Update

			Recalls08/03/2012
			Best Slim
			CTV Best Group Inc.
			Duluth, GA
			bestslim.net
			Undeclared sibutramine
			Recall
			Drugs07/20/2012
			X-Rock 3 Day Pill for Men
			CRM Laboratories
			Distributed by: XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312; or MATE Enterprises, 1020 N. Venetian Drive, Miami, Florida 33139
			xrockhim.com
			Undeclared sildenafil and hydroxythiohomosildenafil
			Recall
			Drugs07/20/2012
			Z-Rock
			CRM Laboratories
			Distributed By: XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312
			zrockusa.com
			Undeclared sildenafil and hydroxythiohomosildenafil
			Recall
			Drugs06/01/2012
			Reumofan Plus
			Riger Naturals S.A.
			n/a
			n/a
			Undeclared dexamethasone, diclofenac sodium and methocarbamol
			News Release
			Drugs
			Consumer Update

			Recalls05/25/2012
			Mojo Nights
			Various Distirbutors
			n/a
			n/a
			Undeclared sulfoaildenafil, sulfosildenafil, and hydroxythiohomosildenafil
			Public Notification
			Drugs05/25/2012
			Kaboom Action Strips
			Various Distributors
			n/a
			kaboomformen.com
			Undeclared sulfoaildenafil
			Public Notification
			Drugs05/22/2012
			EreXite
			Various Distributors
			n/a
			amazon.com
			Undeclared tadalafil
			Public Notification
			Drugs05/18/2012
			Libidron
			West Coast Nutritionals, Ltd.
			n/a
			libidron.com; amazon.com
			Undeclared tadalafil
			Recall
			Drugs05/18/2012
			Firminite
			West Coast Nutritionals, Ltd.
			n/a
			firminite.com; amazon.com
			Undeclared tadalafil
			Recall
			Drugs05/18/2012
			Extra Strength Instant Hot Rod
			West Coast Nutritionals, Ltd.
			n/a
			instanthotrodextrastrength.com; amazon.com
			Undeclared tadalafil
			Recall
			Drugs05/16/2012
			VMaxx Rx
			Various Distributors
			n/a
			vmaxxrx.com
			Undeclared sulfoaidenafil
			Public Notification
			Drugs05/16/2012
			Boost — Ultra Sexual Enhancement Formula
			Various Distributors
			n/a
			boostultra.biz
			Undeclared
			Public Notification
			Drugs04/20/2012
			ZenMaxx
			Enhance Nutraceutical
			Malaysia
			zenmaxx.com
			Undeclared  aminotadalafil
			Public Notification
			Drugs
			Warning Letter04/20/2012
			Instant Hard Rod
			Enhance Nutraceutical
			Malaysia
			instanthardrod.com
			Undeclared aminotadalafil
			Public Notification
			Drugs
			Warning Letter04/20/2012
			RigiRx Plus
			Enhance Nutraceutical
			Malaysia
			rigirxplus.com
			Undeclared aminotadalafil
			Public Notification
			Drugs
			Warning Letter04/05/2012
			African Black Ant
			Various Distributors
			n/a
			ebay.com
			Undeclared sildenafil and tadalafil
			Public Notification
			Drugs04/05/2012
			France T253
			Various Distributors
			n/a
			ebay.com
			Undeclared sildenafil
			Public Notification
			Drugs04/03/2012
			Japan Rapid Weight Loss Diet Pills Yellow
			Xiushentang
			n/a
			ebay.com
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs04/03/2012
			Japan Rapid Weight Loss Diet Pills Green
			Xiushentang
			n/a
			ebay.com
			Undeclared phenolphthalein
			Public Notification
			Drugs02/22/2012
			Mince Belle
			Healthy People Co.
			13105 Ramona Blvd Ste F, Irwindale, CA, 91706
			n/a
			Undeclared sibutramine
			Recall
			Drugs02/22/2012
			Everlax
			Healthy People Co.
			13105 Ramona Blvd Ste F, Irwindale, CA, 91706
			n/a
			Undeclared sibutramine
			Recall
			Drugs02/22/2012
			Ever Slim
			Healthy People Co.
			13105 Ramona Blvd Ste F, Irwindale, CA, 91706
			n/a
			Undeclared sibutramine
			Recall
			Drugs02/22/2012
			Ever Slim Shake Mix
			Healthy People Co.
			13105 Ramona Blvd Ste F, Irwindale, CA, 91706
			n/a
			Undeclared sibutramine
			Recall
			Drugs02/22/2012
			Acai-Man Mangosteen Herbal Drink
			Healthy People Co.
			13105 Ramona Blvd Ste F, Irwindale, CA, 91706
			n/a
			Undeclared tadalafil
			Recall
			Drugs02/22/2012
			Perfect Men
			Healthy People Co.
			13105 Ramona Blvd Ste F, Irwindale, CA, 91706
			n/a
			Undeclared tadalafil
			Recall
			Drugs02/18/2012
			Japan Weight Loss Blue
			Various Distributors
			n/a
			vitaminbestbuy.com
			Undeclared sibutramine and ephedrine alkaloids
			Public Notification
			Drugs02/18/2012
			Man King
			Various Distributors
			n/a
			vitaminbestbuy.com
			Undeclared sildenafil
			Public Notification
			Drugs02/18/2012
			Hard Ten Days
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs02/10/2012
			RegenArouse
			Regeneca, Inc.
			n/a
			n/a
			Undeclared tadalafil
			Recall
			Drugs11/10/2011
			Virility Max
			Keime Inc dba Barry's Vitamins
			n/a
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs10/18/2011
			A-Slim 100% Natural Slimming Capsule
			H&S GMP Factory
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			Health Slimming Coffee
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			Leisure 18 Slimming Coffee
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			P57 Hoodia
			Huikng Pharmaceutical
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			Magic Slim Weight Reduction Capsule
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			Sheng Yuan Fang
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			PhentraBurn Slimming Capsules
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			Tengda
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			Acai Berry Soft Gel ABC
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			Fruit Plant Lossing Fat Capsule
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			Botanical Slimming
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			Pai You Guo Slim Tea
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs10/18/2011
			Lose Weight Coffee
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			DaiDaiHuaJiaoNang
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Public Notification
			Drugs10/18/2011
			Advanced Slim 5
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			Magic Slim Tea
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			Ja Dera 100% Natural Weight Loss Supplement
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/18/2011
			Slender Slim 11
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs10/03/2011
			Uprizing 2.0
			Superior Metabolic Technologies Inc
			Marietta, GA
			n/a
			Undeclared superdrol, a synthetic steroid
			Recall
			Drugs07/08/2011
			Meizitang Botanical Slimming 100% Natural Soft Gel
			Intercharm Inc.
			Fort Lauderdale, FL
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall07/08/2011
			Slim Forte Slimming Coffee
			Intercharm Inc.
			Fort Lauderdale, FL
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall07/08/2011
			Slim Forte Slimming Capsules
			Intercharm Inc.
			Fort Lauderdale, FL
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall07/08/2011
			Slim Forte Slimming Capsule
			LA Beauty Store, Inc.
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs07/08/2011
			Slim Forte Double Power Slimming Capsules
			LA Beauty Store, Inc.
			n/a
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs05/29/2011
			ViaXtreme
			Various Distributors
			n/a
			n/a
			Undeclared sulfoaildenafil
			Public Notification
			Drugs05/10/2011
			Slim Xtreme Herbal Slimming Capsule
			Globe All Wellness, LLC
			2854 Stirling Rd Suite G
			Hollywood, FL 33020
			n/a
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall04/28/2011
			Regenerect
			Ethos Environmental, Inc.
			n/a
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs03/28/2011
			THE BEST Enhancement Supplement
			AVNS Inc
			n/a
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs03/25/2011
			Male Enhancer
			USA Far Ocean Group Inc.
			1609 W. Valley Blvd., #338, Alhambra, CA 91803
			n/a
			Undeclared tadalafil
			Recall
			Drugs03/25/2011
			X-Hero
			USA Far Ocean Group Inc.
			1609 W. Valley Blvd., #338, Alhambra, CA 91803
			n/a
			Undeclared sulfosildenafil
			Recall
			Drugs03/22/2011
			U-Prosta
			USA Far Ocean Group Inc.
			1609 W. Valley Blvd., #338, Alhambra, CA 91803
			n/a
			Undeclared terazosin
			Recall
			Drugs03/16/2011
			Black Ant
			Various Distributors
			n/a
			n/a
			Undeclared sildenafil
			Public Notification
			Drugs02/24/2011
			RegenErect
			Regeneca, Inc.
			n/a
			n/a
			Undeclared tadalafil
			Recall
			Drugs02/22/2011
			Extenze Tablets
			Biotab Nutraceuticals, Inc.
			n/a
			n/a
			Undeclared tadalafil and sildenafil
			Recall
			Drugs
			News Release02/11/2011
			Svelte 30
			Svelte 30 Nutritional Consultants
			Kissimmee, FL
			svelte.com
			Undeclared sibutramine
			Recall
			Drugs01/31/2011
			Fruta Planta
			Godi International, Corp.
			FL
			n/a
			Undeclared sibutramine
			Recall
			Drugs01/31/2011
			Reduce Weight Fruta Planta
			Godi International, Corp.
			FL
			n/a
			Undeclared sibutramine
			Recall
			Drugs01/18/2011
			Nite Rider Maximum Sexual Enhancer For Men
			Kanec USA Inc
			n/a
			n/a
			Undeclared sildenafil
			Recall
			Drugs01/18/2011
			STUD Capsule for Men
			Kanec USA Inc
			n/a
			n/a
			Undeclared sildenafil
			Recall
			Drugs01/12/2011
			Celerite Slimming Capsules
			Shaping Beauty, Inc.
			Southampton, PA
			celeriteweightloss.com; shapingbeauty.com
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall01/03/2011
			Reduce Weight Fruta Planta
			PRock Marketing LLC
			N/A
			frutaplanta.com
			Undeclared sibutramine
			Recall
			Drugs12/30/2010
			Passion Coffee
			Drive Total Energy
			n/a
			drivetotalenergy.com
			Undeclared sulfoaildenafil
			Public Notification
			Drugs12/30/2010
			RockHard Extreme
			Drive Total Energy
			n/a
			drivetotalenergy.com
			Undeclared sulfoaildenafil
			Public Notification
			Drugs12/22/2010
			Fruta Planta
			PRock Marketing LLC
			n/a
			frutaplanta.com
			Undeclared sibutramine
			Public Notification
			Drugs
			Recall12/22/2010
			Pandora
			RockHard Laboratories
			n/a
			n/a
			Undeclared analogue of Sildenafi
			Recall
			Drugs12/22/2010
			RockHard Weekend
			RockHard Laboratories
			n/a
			n/a
			Undeclared analogue of Sildenafi
			Recall
			Drugs12/15/2010
			Man Up Now
			Synergy Distribution LLC
			n/a
			n/a
			Undeclared sulfoaildenafil
			News Release
			Drugs11/19/2010
			Vigor-25
			Piston Corp.
			n/a
			n/a
			Undeclared sildenafil
			News Release
			Drugs10/27/2010
			Duro Extend Capsules For Men
			Intelli Health Products
			80 Southwest 8th Street
			Miami, FL 33130
			n/a
			Undeclared sulfoaidenafil
			Recall
			Drugs
			Expanded Recall10/08/2010
			Slimming Beauty Bitter Orange Slimming Capsules
			Beautiful Health Inc.
			n/a
			n/a
			Undeclared sibutramine
			News Release
			Drugs10/07/2010
			Novedex XT
			Gaspari Nutrition Incorproated
			575 Prospect Street - Suite 230, Lakewood, NJ
			n/a
			Contains 3,17-keto-etiocholetriene, also known as ATD
			News Release
			Drugs09/16/2010
			Arom-X Capsules
			Advanced Muscle Science
			4590 Deodar St., Silver Springs, Nevada 89429
			n/a
			Contains 1,4,6 etioallocholan-dione, also known as ATD
			Recall
			Drugs09/16/2010
			Arom-X UTT Liquid
			Advanced Muscle Science
			4590 Deodar St., Silver Springs, Nevada 89429
			n/a
			Contains 1,4,6 etioallocholan-dione, also known as ATD
			Recall
			Drugs09/16/2010
			Arom-XL Liquid
			Advanced Muscle Science
			4590 Deodar St., Silver Springs, Nevada 89429
			n/a
			Contains 1,4,6 etioallocholan-dione, also known as ATD
			Recall
			Drugs09/16/2010
			4-AD Capsules
			Advanced Muscle Science
			4590 Deodar St., Silver Springs, Nevada 89429
			n/a
			Contains 1,4,6 etioallocholan-dione, also known as ATD
			Recall
			Drugs09/16/2010
			Decavol Capsules
			Advanced Muscle Science
			4590 Deodar St., Silver Springs, Nevada 89429
			n/a
			Contains 1,4,6 etioallocholan-dione, also known as ATD
			Recall
			Drugs09/16/2010
			Reversitol
			Tribravus Enterprises, LLC d/b/a/ iForce Nutrition, LLC
			1305 Hot Spring Way #103, Vista CA 92081
			n/a
			Contains 6-Etioallochol-1,4-Diene-3,17-Dione, also known as ATD
			Recall
			Drugs09/15/2010
			Off Cycle II Hardcore
			Fizogen Precision Technologies
			3133 Fortune Way, Suite #4, Wellington, FL 33414
			n/a
			Contains 3,17-keto-etiochol-triene, also known as ATD
			Recall
			Drugs09/14/2010
			Clomed
			KiloSports Inc.
			Phoenix, AZ
			n/a
			Undeclared aromatase inhibitor
			Recall
			Drugs09/13/2010
			ArimaDex
			Genetic Edge Technologies
			Phoenix, AZ
			n/a
			Undeclared aromatase inhibitor
			News Release
			Drugs08/25/2010
			TimeOut Capsules
			Various Distributors
			n/a
			n/a
			Undeclared hydroxythiohomosildenafil
			News Release
			Drugs08/18/2010
			Mr. Magic Male Enhancer from Don Wands
			Glow Industries, Inc.
			Perrysburg, OH
			n/a
			Undeclared hydroxythiohomosildenafil and sulfoaildenafil
			Recall
			Drugs08/10/2010
			Stiff Nights
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Aziffa
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Size Matters
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Erex
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Mojo
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Hard Drive
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Eyeful
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Red Magic
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Straight Up
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Zotrex
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Monster Excyte
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			WOW
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Xaitrex
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Verect
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Prolatis
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Xytamax
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Maxyte
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Libidinal
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			OMG
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			OMG45
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/10/2010
			Zilex (with Golden Spear)
			Novacare LLC
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/09/2010
			Prolatis'
			Prolatis'
			Salt Lake City, UT
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs08/06/2010
			Solo Slim®
			EZVille, Ltd.
			Ronkonkoma, NY
			n/a
			Undeclared didesmethyl sibutramine
			Recall
			Drugs08/06/2010
			Revivexxx® Extra Strength
			EZVille, Ltd.
			Ronkonkoma, NY
			n/a
			Undeclared tadalafil
			Recall
			Drugs07/28/2010
			Ejaculoid XXTREME
			Nutraloid Labs Inc.
			Kingston, NY
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs07/28/2010
			Stimuloid II
			Nutraloid Labs Inc.
			Kingston, NY
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs07/22/2010
			Joyful Slim Herb Supplement
			J & H Besta Corp.
			Hicksville, NY
			n/a
			Undeclared desmethyl sibutramine
			Recall
			Drugs07/16/2010
			Slim-30 Herb Supplement
			J & H Besta Corp.
			Hicksville, NY
			n/a
			Undeclared N-desmethyl sibutramine
			Recall
			Drugs
			Expanded Recall07/16/2010
			Vialipro
			Good Health, Inc.
			Canutillo, TX
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs07/08/2010
			Que She
			Various Distributors
			n/a
			n/a
			Undeclared fenfluramine, propanolol, sibutramine, ephedrine
			Recall
			Drugs06/19/2010
			Magic Power Coffee
			INZ DISTRIBUTORS INC./MAGIC POWER COFFEE INC.
			Brooklyn, NY
			n/a
			Undeclared hydroxythiohomosildenafil
			News Release
			Drugs
			Recall

			Consumer Update06/04/2010
			Rock Hard Weekend
			Atlas Operations, Inc.
			325 Sw 15th Ave, Pompano Beach, FL 33069-3246
			n/a
			CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
			Warning Letter
			Drugs06/04/2010
			On Cycle II Hardcore
			Atlas Operations, Inc.
			325 Sw 15th Ave, Pompano Beach, FL 33069-3246
			n/a
			CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
			Warning Letter
			Drugs06/04/2010
			Sleep Quick Strips
			Atlas Operations, Inc.
			325 Sw 15th Ave, Pompano Beach, FL 33069-3246
			n/a
			CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
			Warning Letter
			Drugs06/04/2010
			Sleep Once Again
			Atlas Operations, Inc.
			325 Sw 15th Ave, Pompano Beach, FL 33069-3246
			n/a
			CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
			Warning Letter
			Drugs06/04/2010
			Sleep Ease
			Atlas Operations, Inc.
			325 Sw 15th Ave, Pompano Beach, FL 33069-3246
			n/a
			CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
			Warning Letter
			Drugs06/04/2010
			Insomnix
			Atlas Operations, Inc.
			325 Sw 15th Ave, Pompano Beach, FL 33069-3246
			n/a
			CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
			Warning Letter
			Drugs06/04/2010
			Musclextreme Pump Extreme
			Atlas Operations, Inc.
			325 Sw 15th Ave, Pompano Beach, FL 33069-3246
			n/a
			CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
			Warning Letter
			Drugs06/04/2010
			Derma-Tropin
			Atlas Operations, Inc.
			325 Sw 15th Ave, Pompano Beach, FL 33069-3246
			n/a
			CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
			Warning Letter
			Drugs06/04/2010
			GH.X Growth Hormone Extreme
			Atlas Operations, Inc.
			325 Sw 15th Ave, Pompano Beach, FL 33069-3246
			n/a
			CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
			Warning Letter
			Drugs04/20/2010
			Vitalex
			Vitapro, Inc.
			CA
			n/a
			Undeclared acetildenafil-analog
			News Release
			Drugs04/12/2010
			Amour Again for Him
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs04/12/2010
			Erectzia
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs04/12/2010
			Ere-xxx by Elite Body
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs04/12/2010
			Ere-xxx by Maxi Elit
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs04/12/2010
			Stamin It
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Warning Letter04/12/2010
			Vigor 100
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs04/12/2010
			Whatz Up Rx
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs04/02/2010
			Stud Capsule
			Kanec USA Inc.
			5061 South State Road 7. Ste 602, Davie FL 33314
			n/a
			Undeclared sildenafil
			Recall
			Drugs03/30/2010
			MasXtreme
			Natural Wellness Inc.
			440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441
			n/a
			Undeclared aildenafil and phentolamine; undeclared aminotadalafil
			Recall
			Drugs
			Expanded Recall01/15/2010
			Advanced Muscle Science Dienedrone
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			Advanced Muscle Science Liquidrone
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			Anabolic Formulation M1, 4AD
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			Anabolic Formulations 1, 4 AD
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			Anabolic Xtreme Hyperdrol X2
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			Anabolic Xtreme 3-AD
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			BCS Labs Testra-Flex
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			Competitive Edge Labs M-Drol
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			Competitive Edge Labs P-Plex
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			Competitive Edge Labs X-Tren
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			4Ever Fit D-Drol
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			Gaspari Novedex XT
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			Gaspari Halodrol Liquigels
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			iForce 1,4 AD BOLD 200
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			iForce MethaDROL
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			iForce Dymethazine
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs01/15/2010
			Monster Caps
			MuscleMaster.com, Inc.
			Northborough, MA
			n/a
			Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs12/11/2009
			Aspire One
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Warning Letter12/11/2009
			Sex Enhancer
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs12/11/2009
			Staminil
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall

			Warning Letter12/11/2009
			Sexual Surge
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Love Fuel
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Vaxitrol
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Love Fuel 2
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs12/11/2009
			Erexa
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Zenerect
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Arousin
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			72 Hours
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall

			Warning Letter12/11/2009
			Bulk- Unlabeled
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs12/11/2009
			Enhancement
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Red Hot Sex
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Libiplus
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Erexxx
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs12/11/2009
			Tacktol
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Amour for him
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs12/11/2009
			Erousa
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Rockhard
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs12/11/2009
			Ezerex
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Topviril
			Atlas Operations, Inc.
			Pompano Beach, FL
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Vierect
			Atlas Operations, Inc.
			n/a
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall

			Warning Letter12/11/2009
			APL
			Atlas Operations, Inc.
			n/a
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs12/11/2009
			Clyamax
			Atlas Operations, Inc.
			n/a
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Rainbow Rocket
			Atlas Operations, Inc.
			n/a
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Finally On Demand
			Atlas Operations, Inc.
			n/a
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall

			Warning Letter12/11/2009
			Xtremexcite
			Atlas Operations, Inc.
			n/a
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall12/11/2009
			Whatzup
			Atlas Operations, Inc.
			n/a
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs12/11/2009
			Depth Charge
			Atlas Operations, Inc.
			n/a
			n/a
			Undeclared sulfoaildenafil
			Recall
			Drugs
			Expanded Recall11/12/2009
			Pai You Guo
			GMP Herbal Products, Inc.
			Westminster, CA
			n/a
			Undeclared sibutramine and phenolphthalein
			Recall
			Drugs11/12/2009
			Bromodrol
			IDS Sports
			n/a
			n/a
			Undeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”
			Recall
			Drugs11/12/2009
			Dual Action Grow Tabs
			IDS Sports
			n/a
			n/a
			Undeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”
			Recall
			Drugs11/12/2009
			Grow Tabs
			IDS Sports
			n/a
			n/a
			Undeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”
			Recall
			Drugs11/12/2009
			Mass Tabs
			IDS Sports
			n/a
			n/a
			Undeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”
			Recall
			Drugs11/12/2009
			Ripped Tabs TR
			IDS Sports
			n/a
			n/a
			Undeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”
			Recall
			Drugs11/09/2009
			RockHard Weekend
			RockHard Laboratories
			Atlanta, GA
			n/a
			Undeclared sulfoaildenfil
			Recall
			Drugs11/03/2009
			4Ever Fit D-Drol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Advanced Muscle Science Dienedrone
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Advanced Muscle Science Liquidrone UTT
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Anabolic Xtreme Hyperdrol X2
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			APS (aka Advanced Muscle Science) Mastavol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			APS (aka Advanced Muscle Science) Revamp
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			APS (aka Advanced Muscle Science) Ultra Mass Stack
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			APS (aka Advanced Muscle Science) Ripped Stack
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Better Body Sports Finadex
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Black China Labs Straight Drol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Black China Labs Straight Phlexed
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Body Conditioning Solutions TestraFLEX
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Bjorklund Methyldrostanolone
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			BOSC Enterprises Epi-Tren
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			BOSC Enterprises Magna Drol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Chaparral Labs Epivol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Chaparral Labs Pheravol-V
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Competitive Edge Labs M-Drol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Competitive Edge Labs P-Plex
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Competitive Edge Labs X-tren
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Diabolic Labs Epio-Plex
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Diabolic Labs Finabolic 50
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Diabolic Labs Revenge
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Ergopharm 6-OXO
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Ergopharm 6-OXO Extreme
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			EST (aka Engineered Sports Technology) MethAnstance
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Extreme Labs Susto-Test Depot
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Fizogen ON Cycle II Hardcore
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			G.E.T/ (Genetic Edge Technologies) SUS-500
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs
			News Release11/03/2009
			G.E.T/ (Genetic Edge Technologies) Tren-250
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Hardcore Formulations T-Roid
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			I Force Nutrition 1,4 AD Bold 200
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			I Force Dymethazine/Reversitol Combo Pack
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			I Force Reversitol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			I Force Nutrition 17a PheraFLEX
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			I Force Nutrition Dymethazine
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			I Force Nutrition Methadrol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs
			News Release11/03/2009
			IDS (aka Innovative Delivery Systems) Bromodrol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			IDS (aka Innovative Delivery Systems) Grow Tabs TR
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			IDS (aka Innovative Delivery Systems) Mass Tabs
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			IDS (aka Innovative Delivery Systems) Oxodrol Pro
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			IDS (aka Innovative Delivery Systems) Ripped Tabs TR
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			IDS (aka Innovative Delivery Systems) Rapid Release
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Ripped Tabs
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Kilo Sports Massdrol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Kilo Sports Phera-Mass
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Kilo Sports Trenadrol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids,, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Monster Caps Monster Caps
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Myogenix Spawn
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Nutra Coastal D-Stianozol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs
			News Release11/03/2009
			Nutra Coastal H-Drol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Nutra Coastal MDIT
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Nutra Coastal S-Drol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Nutra Coastal Trena
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Performance Anabolics Methastadrol
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Performance Anabolics Tri-Methyl X
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Purus Labs E-pol Inslinsified
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Purus Labs Nasty Mass
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Rage RV2
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Rage RV3
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Rage RV4
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Rage RV5
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs
			News Release11/03/2009
			Redefine Nutrition Finaflex 550-XD
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Redefine Nutrition Finaflex Ripped
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Transform Supplements Forged Extreme Mass
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs11/03/2009
			Transform Supplements Forged Lean Mass
			Bodybuilding.com, LLC
			Boise, ID
			bodybuiliding.com
			May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
			Recall
			Drugs09/23/2009
			Pineapple Fat Reducing Slimming Capsule
			Platinum Strategies Inc
			1500 N, Curry Pike, Bloomington, IN 47404
			911healthshop.com
			Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
			Warning Letter
			Drugs
			Close-out Letter09/23/2009
			Tomato Slimming (Lose Weight)
			Platinum Strategies Inc
			1500 N, Curry Pike, Bloomington, IN 47404
			911healthshop.com
			Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
			Warning Letter
			Drugs
			Close-out Letter09/23/2009
			Slim Up
			Platinum Strategies Inc
			1500 N, Curry Pike, Bloomington, IN 47404
			911healthshop.com
			Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
			Warning Letter
			Drugs
			Close-out Letter09/23/2009
			Fresh Lemon Slimming (Xian Ning Meng Shou Shen)
			Platinum Strategies Inc
			1500 N, Curry Pike, Bloomington, IN 47404
			911healthshop.com
			Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
			Warning Letter
			Drugs
			Close-out Letter09/23/2009
			Slim Quick Result 3 in 1
			Platinum Strategies Inc
			1500 N, Curry Pike, Bloomington, IN 47404
			911healthshop.com
			Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
			Warning Letter
			Drugs
			Close-out Letter09/23/2009
			Perfect Combination Balishou Capsule
			Platinum Strategies Inc
			1500 N, Curry Pike, Bloomington, IN 47404
			911healthshop.com
			Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
			Warning Letter
			Drugs
			Close-out Letter09/23/2009
			Apple Slim
			Platinum Strategies Inc
			1500 N, Curry Pike, Bloomington, IN 47404
			911healthshop.com
			Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
			Warning Letter
			Drugs
			Close-out Letter09/23/2009
			Shoufsy Activity Girl
			Platinum Strategies Inc
			1500 N, Curry Pike, Bloomington, IN 47404
			911healthshop.com
			Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
			Warning Letter
			Drugs
			Close-out Letter08/21/2009
			STEAM
			Nutracoastal Trading LLC
			Freeport, NY
			n/a
			Undeclared tadalafil
			Recall
			Drugs07/28/2009
			S-DROL
			Nutracoastal Trading LLC
			Freeport, NY
			n/a
			Undeclared tadalafil
			Recall
			Drugs07/27/2009
			TREN-Xtreme
			American Cellular Labs
			117 Arcadia Drive, Pacifica, CA 94044
			americell-labs.com
			Contains 19-Norandrosta-4,9-diene-3,17 diene; Dietary Supplements/Adulterated/Misbranded
			Warning Letter
			Drugs07/27/2009
			MASS Xtreme
			American Cellular Labs
			117 Arcadia Drive, Pacifica, CA 94044
			americell-labs.com
			Contains 17α-methyl-etioallocholan-2-ene-17b-01; Dietary Supplements/Adulterated/Misbranded
			Warning Letter
			Drugs07/27/2009
			ESTRO Xtreme
			American Cellular Labs
			117 Arcadia Drive, Pacifica, CA 94044
			americell-labs.com
			Contains 4-hydroxyandrostenedione (4-0HA); Dietary Supplements/Adulterated/Misbranded
			Warning Letter
			Drugs07/27/2009
			AH-89-Xtreme
			American Cellular Labs
			117 Arcadia Drive, Pacifica, CA 94044
			americell-labs.com
			Contains 5a-androstano[3,2-c]pyrazole-3-one-*17B*-01-THP-ether; Dietary Supplements/Adulterated/Misbranded
			Warning Letter
			Drugs07/27/2009
			HMG Xtreme
			American Cellular Labs
			117 Arcadia Drive, Pacifica, CA 94044
			americell-labs.com
			Contains 2a,3a-epithio-17a-methyl-17~-hydroxy-5a-etioallocholane; Dietary Supplements/Adulterated/Misbranded
			Warning Letter
			Drugs07/27/2009
			MMA-3 Xtreme
			American Cellular Labs
			117 Arcadia Drive, Pacifica, CA 94044
			americell-labs.com
			Contains Androsta-1 ,4-dien-3, 17-dione; Dietary Supplements/Adulterated/Misbranded
			Warning Letter
			Drugs07/27/2009
			VNS-9 Xtreme
			American Cellular Labs
			117 Arcadia Drive, Pacifica, CA 94044
			americell-labs.com
			Contains 17a-methyl-4-chloro-androsta-1,4-diene-3B, 17B-diol,1-androsteron; Dietary Supplements/Adulterated/Misbranded
			Warning Letter
			Drugs07/27/2009
			TT-40-Xtreme
			American Cellular Labs
			117 Arcadia Drive, Pacifica, CA 94044
			americell-labs.com
			Contains 1-androsterone; Dietary Supplements/Adulterated/Misbranded
			Warning Letter
			Drugs07/15/2009
			LibieXtreme
			Opteron 1 Inc. dba Nature & Health Co.
			Brea, CA
			n/a
			Undeclared aminotadafil
			Recall
			Drugs07/15/2009
			Y-4ever
			Opteron 1 Inc. dba Nature & Health Co.
			Brea, CA
			n/a
			Undeclared sulfoaidenafil
			Recall
			Drugs07/15/2009
			Libimax X Liquid
			Opteron 1 Inc. dba Nature & Health Co.
			Brea, CA
			n/a
			Undeclared aminotadafil
			Recall
			Drugs07/15/2009
			Powermania Liquid
			Opteron 1 Inc. dba Nature & Health Co.
			Brea, CA
			n/a
			Undeclared sulfoaidenafil
			Recall
			Drugs07/15/2009
			Powermania Capsule
			Opteron 1 Inc. dba Nature & Health Co.
			Brea, CA
			n/a
			Undeclared sulfoaidenafil
			Recall
			Drugs07/15/2009
			Herbal Disiac
			Opteron 1 Inc. dba Nature & Health Co.
			Brea, CA
			n/a
			Undeclared sulfoaidenafil
			Recall
			Drugs07/15/2009
			Slimbionic
			Young You Corporation
			19590 Ventura Blvd., Tarzana, CA
			n/a
			Undeclared sibutramine
			Recall
			Drugs07/15/2009
			One Weight Loss Pill
			Young You Corporation
			19590 Ventura Blvd., Tarzana, CA
			n/a
			Undeclared sibutramine
			Recall
			Drugs07/15/2009
			SlimDemand Capsules
			Young You Corporation
			19590 Ventura Blvd., Tarzana, CA
			n/a
			Undeclared sibutramine
			Recall
			Drugs07/15/2009
			Botanical Weight Loss
			Young You Corporation
			19590 Ventura Blvd., Tarzana, CA
			n/a
			Undeclared sibutramine
			Recall
			Drugs07/13/2009
			Libipower Plus
			Haloteco
			Los Angeles, CA
			n/a
			Undeclared tadalafil
			Recall
			Drugs06/15/2009
			Stamina-Rx
			Hi-Tech Pharmaceuticals, Inc.
			6015-B Unity Dr., Norcross, GA 30071
			n/a
			Undeclared benzamidenafil
			Recall
			Drugs04/27/2009
			Libimax
			Opteron 1 Inc. dba Nature & Health Co.
			Brea, CA
			n/a
			Undeclared tadalafil
			Recall
			Drugs04/20/2009
			ProSlim Plus
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			3 DAYS fit
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			EIGHT FACTOR DIET
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			24hours Diet
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			Slim 3in1 M-18 ROYAL DIET
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			3X SLIMMING POWER
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			Extrim Plus 24 Hours RE-BURN Formula
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			Slim 3in1 EXTRA SLIM FORMULA
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			Slim 3in1 EXTRA SLIM WAIST FORMULA
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			SLIM EXPRESS 360o C
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			SLIM EXPRESS 4in1
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			ROYAL SLIMMING FORMULA
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			BODY CREATOR
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			Slim Waistline
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			BODY SHAPING
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			PERFECT SLIM
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			Perfect Slim 100% Natural Herbal Essence
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			IMELDA Perfect Slim
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			Slim Waist Formula
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			Super Slimming
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			2 DAY DIET
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			Powerful Slim
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			BODY SHAPING
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			SUPER FAT BURNER
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			SLIMMING FORMULA
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			SLIM FAST 2
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			SLIM FAST
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			Slim up
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			7 DAYS DIET
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			Perfect Slim Up
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			JM Fat Reducer
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			SlimBurn
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			21 Double SLIM
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs04/20/2009
			TRIM PLUS 2
			Universal ABC Beauty Supply International, Inc.
			Brooklyn, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs03/11/2009
			Zencore Plus
			Bodee LLC
			Century City, CA
			n/a
			Undeclared benzamidenafil
			Recall
			Drugs01/29/2009
			Venom Hyperdrive 3.0
			Applied Lifescience Research Industries Inc. (ALR Industries)
			Oak View, CA
			n/a
			Undeclared sibutramine
			News Release
			Drugs12/22/2008
			2 Day Diet
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			2 Day Diet Slim Advance
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			2x Powerful Slimming
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			3 Day Diet
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			3 Days Fit
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			3x Slimming Power
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenytoin
			Q&A
			Drugs12/22/2008
			5x Imelda Perfect Slimming
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			7 Day Herbal Slim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			7 Days Diet
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			7 Diet
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			7 Diet Day/Night Formula
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			8 Factor Diet
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Q&A
			Drugs12/22/2008
			Eight Factor Diet
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			21 Double Slim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			24 Hours Diet
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Q&A
			Drugs12/22/2008
			999 Fitness Essence
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			BioEmagrecim
			Various Distributors
			n/a
			n/a
			Undeclared fenproporex; fluoxetine and furosemide
			Q&A
			Drugs12/22/2008
			Body Creator
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Body Shaping
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Body Slimming
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Cosmo Slim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Extrim Plus
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenytoin
			Q&A
			Drugs12/22/2008
			Extrim Plus 24 Hour Reburn
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Fasting Diet
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Fatloss Slimming
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Q&A
			Drugs12/22/2008
			GMP
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Herbal Xenicol
			Various Distributors
			n/a
			n/a
			Undeclared cetilistat
			Q&A
			Drugs12/22/2008
			Imelda Fat Reducer
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Imelda Perfect Slim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Q&A
			Drugs12/22/2008
			JM Fat Reducer
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Lida DaiDaihua
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Meili
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Meizitang
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Miaozi MeiMiaoQianZiJiaoNang
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Miaozi Slim Capsules
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Natural Model
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Perfect Slim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Perfect Slim 5x
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Q&A
			Drugs12/22/2008
			Perfect Slim Up
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Phyto Shape
			Various Distributors
			n/a
			n/a
			Undeclared rimonabant
			Q&A
			Drugs12/22/2008
			Powerful Slim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			ProSlim Plus
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Reduce Weihgt
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Royal Slimming Formula
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Q&A
			Drugs12/22/2008
			Sana Plus
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slim 3 in 1
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slim 3 in 1 Extra Slim Formula
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slim 3 in 1 Extra Slim Waist Formula
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slim 3 in 1 M18 Royal Diet
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slim 3 in 1 Slim Formula
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slim Burn
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slim Express 4 in 1
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slim Express 360
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slim Tech
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slim Up
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slim Waist Formula
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slim Waistline
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slimbionic
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Sliminate
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Slimming Formula
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Somotrim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Starcaps
			Various Distributors
			n/a
			n/a
			Undeclared bumetanide
			Q&A
			Drugs12/22/2008
			Super Fat Burner
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Superslim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Q&A
			Drugs12/22/2008
			Super Slimming
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Trim 2 Plus
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Triple Slim
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Venom Hyperdrive 3.0
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Waist Strength Formula
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Xsvelten
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine
			Q&A
			Drugs12/22/2008
			Zhen de Shou
			Various Distributors
			n/a
			n/a
			Undeclared sibutramine and phenolphthalein
			Q&A
			Drugs11/26/2008
			STARCAPS DIET SYSTEM
			Balanced Health Products, Inc.
			n/a
			n/a
			Undeclared bumetanide
			Recall
			Drugs
			Expanded Recall11/23/2008
			Zhen de Shou Fat Loss
			Fashion Sanctuary
			San Diego, CA
			n/a
			Undeclared sibutramine
			Recall
			Drugs07/23/2008
			Viapro
			EG Labs, LLC
			New York, NY
			
			Undeclared  thio-methisosildenafil
			Recall
			Drugs07/01/2008
			Rize 2 The Occasion
			Jack Distribution, LLC; G & N works, Inc.; Devine Distribution, Inc
			1501 Green Road Unit C Pompano Beach, FL
			n/a
			Undeclared thiomethisosildenafil
			Recall
			Drugs
			Expanded Recall07/01/2008
			Rose 4 Her
			Jack Distribution, LLC; G & N works, Inc.; Devine Distribution, Inc
			1501 Green Road Unit C Pompano Beach, FL
			n/a
			Undeclared thiomethisosildenafil
			Recall
			Drugs
			Expanded Recall05/29/2008
			Viril-Ity-Power (VIP) Tabs
			International Pharmaceuticals, Ltd.
			P.O. Box 5165, Bradford, MA 01835
			n/a
			Undeclared hydroxyhomosildenafil
			Recall
			Drugs05/27/2008
			Xiadafil VIP Tabs
			SEI Pharmaceuticals
			Miami, FL
			n/a
			Undeclared hydroxyhomosildenafil
			News Release
			Drugs03/31/2008
			Maxidus
			KG Enterprises LLC
			PO Box 5156, El Dorado Hills, CA 95742
			n/a
			Undeclared sildenafil and tadalafil
			Recall
			Drugs03/25/2008
			Blue Steel
			Active Nutraceuticals; Marion Group
			Carrollton, GA
			n/a
			Undeclared substances that are similar in chemical structure to sildenafil
			News Release
			Drugs03/25/2008
			Hero
			Active Nutraceuticals; Marion Group
			Carrollton, GA
			n/a
			Undeclared substances that are similar in chemical structure to sildenafil
			News Release
			Drugs02/28/2008
			Aspire36
			Palo Alto Labs
			265 SW Port St. Lucie Blvd., Suite 252, Port St. Lucie, FL 34984
			n/a
			Undeclared aildenafil and dimethyl sildenafil thione (sulfoaildenafil)
			Recall
			Drugs02/28/2008
			Aspire Lite
			Palo Alto Labs
			265 SW Port St. Lucie Blvd., Suite 252, Port St. Lucie, FL 34984
			n/a
			Undeclared aildenafil and dimethyl sildenafil thione (sulfoaildenafil)
			Recall
			Drugs12/28/2007
			Super Shangai
			Shangai Distributor, Inc.
			Coamo, Puerto Rico
			n/a
			Undeclared sildenafil analogues
			Recall
			Drugs12/28/2007
			Strong Testis
			Shangai Distributor, Inc.
			Coamo, Puerto Rico
			n/a
			Undeclared sildenafil analogues
			Recall
			Drugs12/28/2007
			Shangai Ultra
			Shangai Distributor, Inc.
			Coamo, Puerto Rico
			n/a
			Undeclared sildenafil analogues
			Recall
			Drugs12/28/2007
			Shangai Ultra X
			Shangai Distributor, Inc.
			Coamo, Puerto Rico
			n/a
			Undeclared sildenafil analogues
			Recall
			Drugs12/28/2007
			Lady Shangai
			Shangai Distributor, Inc.
			Coamo, Puerto Rico
			n/a
			Undeclared sildenafil analogues
			Recall
			Drugs12/28/2007
			Shangai Regular (Shangai Chaojimengnan)
			Shangai Distributor, Inc.
			Coamo, Puerto Rico
			n/a
			Undeclared sildenafil analogues
			Recall
			Drugs12/28/2007
			Naturalë Super Plus
			Shangai Distributor, Inc.
			Coamo, Puerto Rico
			n/a
			Undeclared APIs for erectile dysfunction
			Consumer Update
			Drugs11/21/2007
			Encore Tabs
			Bodee LLC
			Avenue of the Stars, 702E, Century City, CA 90067
			n/a
			Undeclared aminotadalafil
			Recall
			Drugs09/12/2007
			Axcil
			TWC Global, LLC
			530 Showers Drive, Suite 7-129, Mountain View, CA 94040
			n/a
			Undeclared sildenafil, sulfosildenafil and sulfohomosildenafil
			Recall
			Drugs09/12/2007
			Desirin
			TWC Global, LLC
			530 Showers Drive, Suite 7-129, Mountain View, CA 94040
			n/a
			Undeclared sildenafil, sulfosildenafil and sulfohomosildenafil
			Recall
			Drugs08/31/2007
			Zencore Tabs
			Bodee LLC
			Avenue of the Stars, 702E, Century City, CA 90067
			n/a
			Undeclared aminotadalafil, sulfosildenafil, sulfohomosildenafil
			Recall
			Drugs08/17/2007
			METABOSLIMTM Apple Cider Vinegar
			Confidence Inc.
			Port Washington, NY
			n/a
			Undeclared sibutramine
			Recall
			Drugs06/14/2007
			Long Weekend
			Confidence Inc.
			Port Washington, NY
			n/a
			Undeclared tadalafil
			Recall
			Drugs04/17/2007
			H S Joy of Love
			Jen-On Herbal Science International, Inc.
			205 Russell St., City of Industry, CA 91744
			n/a
			Undeclared piperadino vardenafil
			Recall
			Drugs03/16/2007
			Rhino Max (Rhino V Max)
			Cosmos Trading, Inc.
			543 Olympic Blvd, Suite # 419, Los Angeles, CA 90015
			n/a
			Undeclared aminotadalafil
			Safety Alert
			Drugs
			Recall



*1**Product name linked to Flickr image when available.*

**The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes.*

                                                                                  Content current as of:
      11/14/2023Health Fraud Scams

          
                        El Fraude en la Salud
 
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