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
|Date||Brand Name(s)||Product Description||Recall Reason Description||Company Name||Terminated Recall||Excerpt|
|Lilly||Glucagon Emergency Kit||Loss of potency||Eli Lilly and Company|
|IntegraDose Compounding Services, LLC||Cefazolin||Lack of sterility assurance.||IntegraDose Compounding Services, LLC|
|CHANTIX||Varenicline tablets||N-nitroso-varenicline above acceptable daily intake level||Pfizer|
|Ruzurgi®||Ruzurgi® (amifampridine) 10 mg tablets||Exceeds Specification for Total Yeast and Mold Counts||Jacobus Pharmaceutical Company Inc.|
|Azurity||Firvanq||Product kit may contain incorrect diluent.||Azurity Pharmaceuticals, Inc.|
|Hospira||Aminosyn II, 15%, An Amino Acid Injection, Sulfite||Presence of visible particulate matter||ICU Medical, Inc.|
|Teligent||Lidocaine HCl Topical Solution 4%||Super potency||Teligent Pharma, Inc.|
|CHANTIX||Smoking cessation treatment||N-Nitroso Varenicline content above acceptable daily intake level||Pfizer|
|Max Health||Hydro Pineapple Burn||undeclared sibutramine||Ebay Seller-John Nguyen|
|SterRx, LLC||Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL||Due to waterborne microbial contamination||SterRx, LLC|