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  1. Drug Safety and Availability

Drug Recalls

A 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 at any time to remove a defective drug product from the market.

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

See FDA’s role in drug recalls for more information.
See Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.
For recall notices older than 60 days, see recall and safety alerts archive.

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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 Excerpt
IBSA TIROSINT®-SOL (levothyroxine sodium) Subpotency IBSA Pharma Inc.
Banana Boat Hair & Scalp Spray SPF 30 Due to presence of benzene Edgewell Personal Care
Spectrum Epinephrine bulk API Product discoloration Spectrum Laboratory Products Inc.
Accord Daptomycin for Injection Mislabeling Accord Healthcare, Inc
Hospira, Inc. Vancomycin Injection Presence of Visible Glass Particulates Hospira, Inc.
Multiple brand names After Burn® Cream and First Aid Kits containing After Burn Cream Product is contaminated with Bacillus licheniformis and Bacillus sonorensis. GFA Production
Lupin Quinapril 20 and 40 mg tablets Presence of nitrosamine impurity, N-Nitroso-Quinapril Lupin Pharmaceuticals Inc.
Exela Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial Vial Breakage Exela Pharma Sciences, LLC
Adam’s Polishes Hand sanitizer Presence of methanol Adam’s Polishes, LLC
Aurobindo Pharma USA, Inc. Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, 90’s HDPE bottle Due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril Aurobindo Pharma USA, Inc.
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