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
|Date||Brand Name(s)||Product Description||Recall Reason Description||Company Name||Terminated Recall||Excerpt|
|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.|
|Mylan Institutional LLC||Octreotide Acetate Injection, 500 mcg/mL||Due to glass particulates||Mylan Institutional LLC, a Viatris company|
|Exela & Civica||Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial||Vial Breakage||Exela Pharma Sciences, LLC|