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        Drug Safety and Availability

Drug Recalls

                        
                FDA's Role in Drug Recalls Home
          Drugs
          Drug Safety and Availability
          Drug RecallsDrug Safety and Availability Drug Recalls
  	
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    PrintA drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company to remove a defective drug product from the market or warn patients and consumers about a potential risk.

The list below includes voluntary drug recalls in which public notification has been issued.

Visit FDA’s role in drug recalls for more information.
Visit Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.
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            Terminated Recall
  
  
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                    A Terminated Recall is a recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. Recalls that are not indicated as being terminated are either ongoing or completed.
    
      Date
                                                                            Brand Name(s)
                                                                            Product Description
                                                                            Recall Reason Description
                                                                            Company Name
                                                                            Terminated Recall
                                                                            Excerpt01/29/2024
                                                                                                                                            Neptune’s Fix
                                                                                                                                            Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets
                                                                                                                                            Undeclared Tianeptine
                                                                                                                                            Neptune Resources, LLC01/25/2024
                                                                                                                                            Zendedi
                                                                                                                                            dextroamphetamine sulfate tablets, 30 mg
                                                                                                                                            Mislabeled package
                                                                                                                                            Azurity Pharmaceuticals, Inc.01/24/2024
                                                                                                                                            Robitussin
                                                                                                                                            Cough syrups
                                                                                                                                            Microbial Contamination
                                                                                                                                            Haleon01/22/2024
                                                                                                                                            Multiple brands
                                                                                                                                            Lubricant Eye Drops & Multi-Symptom Eye Drops
                                                                                                                                            Device & Drug Safety Potential Safety Concerns
                                                                                                                                            Kilitch Healthcare India Limited01/08/2024
                                                                                                                                            Leiters, Compounding Health
                                                                                                                                            Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags
                                                                                                                                            Potential for superpotent drug
                                                                                                                                            Leiters Health12/26/2023
                                                                                                                                            Hospira
                                                                                                                                            4.2% Sodium bicarbonate injection, 8.4% Sodium bicarbonate injection, Atropine sulfate injection
                                                                                                                                            Presence of Glass Particulate Matter
                                                                                                                                            Hospira, Inc.12/22/2023
                                                                                                                                            No Brand
                                                                                                                                            Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAINTM Glass Fliptop Vial
                                                                                                                                            Presence of Glass Particulate Matter
                                                                                                                                            Hospira, Inc.12/22/2023
                                                                                                                                            Americaine
                                                                                                                                            Benzocaine Topical Anesthetic Spray
                                                                                                                                            Presence of benzene
                                                                                                                                            Insight Pharmaceuticals12/18/2023
                                                                                                                                            No Brand
                                                                                                                                            Vigabatrin for Oral Solution, USP 500mg
                                                                                                                                            Due to seal integrity issues allowing for powder leakage from the pouch.
                                                                                                                                            InvaGen Pharmaceuticals Inc.11/29/2023
                                                                                                                                            Magnum
                                                                                                                                            Magnum Male Sexual Enhancement XXL 9800 capsule
                                                                                                                                            Undeclared Sildenafil
                                                                                                                                            Meta Herbal
  
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                                                                                  Content current as of:
      01/30/2024Drug Recalls                
                          

                        FDA's Role in Drug Recalls
 
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