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.

Resources for You

• Recalls, Market Withdrawals, & Safety Alerts
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program
• Enforcement Reports
• Drug Safety Communications
• Drug Alerts and Statements
• FDA Recall Information on Twitter
• Basic Reset and Biogenyx Recalled Products

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Terminated Recall - Any -YesNo

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
01/09/2023	Spectrum	Epinephrine bulk API	Product discoloration	Spectrum Laboratory Products Inc.
12/27/2022	Accord	Daptomycin for Injection	Mislabeling	Accord Healthcare, Inc
12/27/2022	Hospira, Inc.	Vancomycin Injection	Presence of Visible Glass Particulates	Hospira, Inc.
12/27/2022	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
12/21/2022	Lupin	Quinapril 20 and 40 mg tablets	Presence of nitrosamine impurity, N-Nitroso-Quinapril	Lupin Pharmaceuticals Inc.
11/29/2022	Exela	Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial	Vial Breakage	Exela Pharma Sciences, LLC
11/07/2022	Adam’s Polishes	Hand sanitizer	Presence of methanol	Adam’s Polishes, LLC
10/25/2022	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.
10/25/2022	Mylan Institutional LLC	Octreotide Acetate Injection, 500 mcg/mL	Due to glass particulates	Mylan Institutional LLC, a Viatris company
10/13/2022	Exela & Civica	Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial	Vial Breakage	Exela Pharma Sciences, LLC

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