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 In this section:

                Drug Safety and Availability

Drug Safety and Availability

                        Drug Alerts and Statements
          Information about Nitrosamine Impurities in Medications
          Medication Guides
          Drug Safety Communications


                        Food and Drug Administration Overdose Prevention Framework
          Drug Shortages
          FDA Drug Safety Podcasts
          Information by Drug Class
          Medication Errors Related to CDER-Regulated Drug Products
          Postmarket Drug Safety Information for Patients and Providers
          Risk Evaluation and Mitigation Strategies | REMS
          Safe Use Initiative
          Drug Recalls
          Drug Supply Chain Integrity
          Multistate outbreak of fungal meningitis and other infections Home
          Drugs
          Drug Safety and Availability
          Drug Alerts and StatementsDrug Safety and Availability Drug Alerts and Statements
  
  	
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Alerts
	Statements

Alerts

See updates from CDER on fast-moving issues

Date
			Title1/17/2024
			FDA announces shelf-life extension for naloxone nasal spray12/27/2023
			FDA requires updates to labeling for promethazine hydrochloride injection products11/21/2023
			FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks11/3/2023
			FDA warns consumers of hidden drug ingredients in Dr. Ergin’s SugarMD Advanced Glucose Support10/27/2023
			FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection9/18/2023
			FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsules8/22/2023
			FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination8/1/2023
			FDA warns consumers that Tydemy, a prescription oral contraceptive, may have reduced effectiveness5/22/2023
			G-Supress DX Pediatric Cough Drops may have incorrect drug in packaging5/1/2023
			FDA warns consumers to not purchase or use Nose Slap and Soul Slap products marketed for alertness and energy boosting2/9/2023
			Infants at risk for aluminum toxicity with unapproved potassium phosphates drug product2/2/2023
			FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination11/22/2022
			FDA alerts health care professionals of compatibility issues with prefilled glass syringes and certain Luer-activated valve (LAV) connectors11/8/2022
			FDA alerts health care professionals of risks to patients exposed to xylazine in illicit drugs8/18/2022
			FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection4/29/2022
			Bosentan REMS requirements will change June 27, 20224/26/2022
			FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy4/20/2022
			FDA warns consumers not to purchase or use Artri and Ortiga products, which may contain hidden drug ingredients3/30/2022
			FDA warns patients and health care professionals not to use sterile products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding9/17/2021
			FDA alerts patients and health care professionals not to use compounded products intended to be sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy7/28/2021
			FDA alerts patients and health care professionals about clinical trial results showing an increased risk of death associated with Pepaxto (melphalan flufenamide)3/19/2021
			FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company)1/15/2021
			FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only12/3/2020
			FDA alerts healthcare professionals about the risk of medication errors with tranexamic acid injection resulting in inadvertent intrathecal (spinal) injection9/21/2020
			FDA alerts of Perrigo's voluntary albuterol inhaler recall9/8/2020
			FDA alerts health care professionals and oncology clinical investigators about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer8/14/2020
			FDA advises consumers not to use goldenseal root powder distributed by Maison Terre7/2/2020
			FDA warns consumers of risk of methanol contamination in certain hand sanitizers6/19/2020
			FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem6/1/2020
			FDA alerts patients and health care professionals of Amneal and Impax Laboratories epinephrine auto-injector device malfunctions3/24/2020
			FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration10/11/2019
			FDA advises consumers not to use Rompe Pecho cough syrup7/23/2019
			FDA advises patients not to use Herbal Doctor Remedies’ medicines6/28/2019
			FDA warns patients and health care professionals not to use sterile products from Pacifico National Inc., dba AmEx Pharmacy6/25/2019
			FDA alerts consumers not to use Kratom NC’s products6/21/2019
			FDA alerts patients and healthcare professionals to Infusion Options’ voluntary recall due to quality issues2/12/2019
			FDA alerts patients of McDaniel Life-Line’s voluntary recall of Indian Herb2/1/2019
			FDA warns compounders not to use glutathione from Letco Medical to compound sterile drugs12/11/2018
			FDA alerts consumers not to use two e-liquids sold by HelloCig Electronic Technology12/7/2018
			FDA alerts health care professionals and patients not to use drug products intended to be sterile from Promise Pharmacy11/19/2018
			FDA alerts health care professionals and patients not to use sterile drug products from Pharm D Solutions11/8/2018
			FDA alerts consumers of Kadesh Incorporation’s voluntary nationwide recall of Puriton Eye Relief Drops due to non-sterile production conditions11/2/2018
			FDA alerts patients and health care professionals that some EpiPen auto-injectors may not readily slide out of carrier tube10/11/2018
			FDA alerts consumers of Sprayology’s voluntary nationwide recall of homeopathic water-based medicines due to microbial contamination10/4/2018
			FDA alerts consumers and pet owners of Silver Star Brand's voluntary nationwide recall of homeopathic drug products9/14/2018
			FDA alerts consumers of BioLyte Laboratories voluntary recall of NeoRelief9/14/2018
			FDA alerts consumers not to use products distributed by Years to Your Health9/7/2018
			FDA alerts consumers of Beaumont Bio Med's voluntary recall of all water and alcohol-based products8/31/2018
			FDA alerts consumers of HelloLife's voluntary recall of Neuroveen, Respitrol, Thyroveev and Compulsin8/17/2018
			FDA alerts drug makers of a recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China7/10/2018
			FDA announces Ranier's Rx Laboratory voluntary recall of all sterile compounded drug7/5/2018
			FDA advises consumers not to use Blissful Remedies kratom products due to bacterial contamination6/29/2018
			FDA advises health care professionals not to use MedGyn Products Monsel's Solution5/30/2018
			FDA alerts health care professionals, patients, and the drug supply chain not to use stolen fertility drugs, Gonal-f RFF Redi-ject and Gonal-f Multi-Dose4/13/2018
			FDA alerts health care professionals to voluntary nationwide recall of all sterile products from Coastal Meds3/30/2018
			FDA alerts consumers of a nationwide voluntary recall of topical drug products made by Industria Farmacéutica Andrómaco due to contamination3/16/2018
			FDA is alerting consumers of a voluntary recall of Bayer's Alka-Seltzer Plus products due to labeling errors3/16/2018
			FDA warns consumers not to use unapproved erectile dysfunction products advertised on the radio1/12/2018
			FDA notifies health care professionals that Becton-Dickinson replaced problematic rubber stoppers in its syringes10/27/2017
			FDA updates on 2017 Burkholderia cepacia contamination9/1/2017
			FDA alerts health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes manufactured by Foshan Flying Medical Products8/21/2017
			FDA warns consumers about health risks of herbal coffee products from Malaysia containing undeclared active pharmaceutical ingredients and milk8/10/2017
			FDA alerts health care professionals and patients not to use sterile drug products from Vital Rx, dba Atlantic Pharmacy and Compounding7/28/2017
			FDA alerts health care professionals of adverse events associated with Guardian's compounded triamcinolone and moxifloxacin product for intravitreal injection10/12/2016
			FDA updates on multistate outbreak of burkholderia cepacia Infections5/12/2016
			FDA advises health care professionals that counterfeit BiCNU has been discovered in some foreign countries4/15/2016
			FDA alerts health care professionals not to use sterile drug products from Pharmakon Pharmaceuticals, Inc., Noblesville, Indiana4/15/2016
			FDA issues three new draft guidances related to compounding of human drugs4/1/2016
			FDA alerts health care professionals and patients not to use sterile drug products from Medaus Pharmacy, Birmingham, Alabama3/30/2016
			FDA announces voluntary recall of all unexpired compounded drug products produced by Reliable Rexall, San Francisco3/23/2016
			FDA warns consumers not to use "Best Bentonite Clay" laboratory tests indicate elevated levels of lead3/14/2016
			FDA alerts healthcare professionals about clinical trials with Zydelig (idelalisib) in combination with other cancer medicines3/9/2016
			FDA alerts health care professionals and patients not to use human and animal sterile drug products produced and distributed by I.V. Specialty, Ltd., Austin, Texas2/16/2016
			FDA announces Pharmakon Pharmaceuticals voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride2/10/2016
			FDA alerts compounding pharmacies of a nationwide voluntary recall of Syrspend SF and Syrspend SF Grape suspending agents from Fagron Inc., due to microbial contamination with yeast1/28/2016
			FDA warns consumers about health risks with Alikay Naturals - Bentonite Me Baby - Bentonite Clay1/28/2016
			FDA warns consumers not to use Viansilk's "Crema Piel De Seda" ("Silky Skin Cream")1/15/2016
			FDA warns consumers not to use Licorice Coughing Liquid3/2/2018
			FDA working with manufacturers to withdraw Zinbryta from the market in the United States

Statements

Learn about CDER's work to enhance public health

Date
			Title1/29/2024
			FDA revises letter of authorization for the emergency use authorization for Paxlovid1/23/2024
			FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience12/21/2023
			FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain12/15/2023
			FDA approves safety labeling changes for opioid pain medicines10/17/2023
			CDER soliciting comments regarding clinical trial innovation9/21/2023
			FDA issues guidance on using remote oversight tools to help approve drugs9/18/2023
			FDA issues draft guidance regarding confirmatory evidence of clinical trials9/14/2023
			FDA clarifies results of recent advisory committee meeting on oral phenylephrine8/30/2023
			DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems5/23/2023
			FDA issues final guidance on adjusting for covariates in randomized clinical trials5/17/2023
			FDA issues two draft guidances for industry to support the approval of pediatric drug products5/11/2023
			FDA requires updates to clarify labeling of prescription stimulants used to treat ADHD and other conditions4/28/2023
			FDA issues final Nicotine Replacement Therapy Drug Products guidance4/13/2023
			FDA announces new safety label changes for opioid pain medicines4/4/2023
			FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-193/29/2023
			FDA launches Lupus Treatment Consortium in partnership with the Lupus Research Alliance1/20/2023
			FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems11/30/2022
			FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region11/4/2022
			FDA Updates on Bebtelovimab10/21/2022
			FDA issues final guidance about multiple endpoints in clinical trials10/12/2022
			FDA Announces Shortage of Adderall10/6/2022
			FDA Launches AATD Pre-Consortium Partnership with the Critical Path Institute10/3/2022
			FDA Expands CDER NextGen Portal9/8/2022
			FDA draft guidance aims to improve consistency of labeling for nonprescription drugs9/7/2022
			CDER and CBER accept first submission to ISTAND Pilot Program9/1/2022
			FDA initiates the Lysosomal Diseases Pre-Consortium at the Critical Path Institute8/9/2022
			FDA works to avoid shortage of sitagliptin following detection of nitrosamine impurity5/10/2022
			CDER launches new Accelerating Rare disease Cures (ARC) program4/19/2022
			FDA works to protect consumers from potentially harmful OTC skin lightening products2/25/2022
			FDA updates Sotrovimab emergency use authorization2/24/2022
			FDA authorizes revisions to Evusheld dosing2/24/2022
			Approved first generic for Apokyn injection cartridges requires separately packaged pen1/26/2022
			FDA issues series of guidances under Drug Competition Action Plan1/12/2022
			FDA warns about risks of dental problems associated with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain12/23/2021
			FDA Urges Manufacturers to Develop Solutions for iPLEDGE REMS Website10/20/2021
			FDA issues refuse-to-file letter for application for Barth syndrome9/16/2021
			FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-197/30/2021
			FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-197/14/2021
			FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or misleading promotional communications about the product’s benefit7/2/2021
			FDA alerts health care professionals and patients to a voluntary recall of varenicline (Chantix) to the warehouse level5/19/21
			FDA receives HHS grant to expand CURE ID platform for COVID-19 treatments3/26/2021
			CDER perspective on recently published results of EPPPIC meta-analysis3/18/2021
			FDA authorizes revisions to fact sheets to address SARS-CoV-2 variants for monoclonal antibody products under emergency use authorization2/16/2021
			FDA issues warning to AcelRx for making false and misleading claims about the risks and benefits of Dsuvia12/10/2020
			FDA will test ability to receive digital annotated ECG waveform files as agency prepares to transition to new ECG warehouse12/4/2020
			New studies show diabetes drug not proven to improve blood sugar control in pediatric patients10/13/2020
			FDA advises health care professionals and patients about insulin pen packaging and dispensing10/5/2020
			CDER proposes withdrawal of approval for Makena8/26/2020
			FDA works to mitigate shortages of rifampin and rifapentine after manufacturers find nitrosamine impurities8/20/2020
			FDA approves label changes to hydrochlorothiazide to describe small risk of non-melanoma skin cancer3/19/2020
			FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-192/21/2020
			FDA launches new resource to provide easily accessible, more accurate historical drug approval data1/31/2010
			FDA requests withdrawal of bacitracin for injection from market1/30/2020
			FDA revises generic drug application prioritization policy to ensure fairness to applicants, efficiently allocate limited agency resources, and protect the public health7/5/2019
			FDA issues guidance on compounding oral oxitriptan (5-HTP) for patients with tetrahydrobiopterin (BH4) deficiency5/21/2019
			FDA issues draft guidance for industry on the design and evaluation of comparative analytical studies for biosimilarity5/2/2019
			Communications with stakeholders concerning access to compounded oral oxitriptan for patients with tetrahydrobiopterin deficiency4/29/2019
			FDA reminds imaging facilities to follow safety procedures for rubidium 82 generators used in Positron Emission Tomography (PET) myocardial perfusion imaging3/21/2019
			FDA warns about the risks associated with the investigational use of Venclexta in Multiple Myeloma9/26/2018
			FDA announces new and expanded compounding research projects9/20/2018
			FDA analysis finds no new or unexpected safety risks associated with Nuplazid (pimavanserin), a medication to treat the hallucinations and delusions of Parkinson's disease psychosis7/18/2018
			FDA updates and press announcements on angiotensin II receptor blocker (ARB) recalls (Valsartan, Losartan, and Irbesartan)6/28/2018
			FDA approves labeling supplement for Celebrex (celecoxib)6/21/2018
			FDA withdraws draft guidance for industry: Statistical Approaches to Evaluate Analytical Similarity5/22/2018
			FDA video series about biosimilar and interchangeable products5/18/2018
			FDA alerts health care professionals and oncology clinical investigators about an efficacy issue identified in clinical trials for some patients taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as monotherapy to treat urothelial cancer with low expression of PD-L15/16/2018
			FDA reports quality problems for data provided by the firm IQVIA that were used to inform estimates for some controlled substances3/14/2018
			FDA working with manufacturers to withdraw Zinbryta from the market in the United States12/14/2017
			FDA reminds pharmaceutical industry of new drug listing certification requirement due December 31, 201711/14/2017
			FDA works to help relieve the IV fluid shortages in wake of Hurricane Maria9/8/2017
			FDA warns Meridian Medical Technologies about CGMP violations associated with the manufacture of EpiPen8/31/2017
			FDA alerts healthcare professionals and oncology clinical investigators about two clinical trials on hold evaluating KEYTRUDA® (pembrolizumab) in patients with multiple myeloma8/4/2017
			FDA warns consumers not to use Balguti Kesaria Ayurvedic Medicine due to high levels of lead6/20/2017
			FDA issues warning about body-building products labeled to contain steroid and steroid-like substances5/22/2017
			FDA advises drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug product4/13/2017
			FDA announces Standard Homeopathic Company's nationwide voluntary recall of Hyland's teething tablets1/17/2017
			FDA approves a generic of Xyrem with a REMS Program1/12/2017
			FDA issues final guidance on repackaging and revised draft guidance on mixing, diluting, and repackaging biological products1/10/2017
			FDA warns cancer patients not to use PNC-27 products for treatment1/9/2017
			Impact of exclusivity on approval of Arymo ER12/28/2016
			FDA issues guidance on prescription requirement under section 503A12/28/2016
			FDA issues draft guidances on compounding and repackaging radiopharmaceuticals12/15/2016
			FDA proposes six bulk drug substances for inclusion on the 503A bulks list10/25/2016
			FDA approves new changes to testosterone labeling regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS)10/17/2016
			Proposed rule to amend the list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety and effectiveness reasons10/11/2016
			FDA analyses conclude that Xarelto clinical trial results were not affected by faulty monitoring device10/6/2016
			Final rule amending list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety or effectiveness reasons8/12/2016
			FDA finds drugs under investigation in the U.S. related to French BIA 10-2474 drug do not pose similar safety risks8/3/2016
			FDA issues draft guidance on insanitary conditions at compounding facilities7/8/2016
			FDA approves a dedicated syringe to be used with Humulin R U-500 insulin7/7/2016
			FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs6/9/2016
			FDA issues final guidances on interim policy for certain bulk drug substances used in compounding5/26/2016
			Neonatal opioid withdrawal syndrome and medication-assisted treatment with methadone and buprenorphine3/15/2016
			FDA warns consumers about potential risks of using eye drops packaged in bottles with loose safety seals1/22/2016
			FDA works with regulatory partners to understand French-based Biotrial phase 1 clinical study

Archived Alerts and Statements 2010-2015

FDA Archive 2014-2015
	FDA Archive 2010-2013

                                                                                  Content current as of:
      01/29/2024
              
              
Regulated Product(s)
		 DrugsDrug Safety and Availability

          
                        Drug Alerts and Statements
          Information about Nitrosamine Impurities in Medications
          Medication Guides
          Drug Safety Communications


                        Food and Drug Administration Overdose Prevention Framework
          Drug Shortages
          FDA Drug Safety Podcasts
          Information by Drug Class
          Medication Errors Related to CDER-Regulated Drug Products
          Postmarket Drug Safety Information for Patients and Providers
          Risk Evaluation and Mitigation Strategies | REMS
          Safe Use Initiative
          Drug Recalls
          Drug Supply Chain Integrity
          Multistate outbreak of fungal meningitis and other infections
 
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