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.
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 |
---|---|---|---|---|---|---|
Semglee | Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens | Missing Label | Mylan Pharmaceutical Inc. | |||
AVpak | Senna Syrup 5mL | Potential microbial contamination | Lohxa LLC | |||
Viona | Metformin Hydrochloride Extended-Release Tablets | N-Nitrosodimethylamine (NDMA) Impurity | Viona Pharmaceuticals, Inc. | |||
Taro | Clobetasol Propionate | Presence of Ralstonia pickettii bacteria | Taro Pharmaceuticals USA, Inc. | |||
Perrigo | Nitroglycerin Lingual Spray | Unit may not properly dispense medication. | Padagis | |||
Rompe Pecho | Liquid Cold & Flu symptom relief | Microbial contamination | Efficient Laboratories, Inc | |||
Teligent Pharma, Inc. | Lidocaine HCl Topical Solution USP 4%, 50ml | Super potent | Teligent Pharma, Inc. | |||
Edge Pharma, LLC | All drugs compounded at Edge Pharma, LLC | Process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products | Edge Pharma, LLC | |||
Gilead | Veklury® (remdesivir 100 mg for injection) | Presence of glass particulates | Gilead Sciences Inc. | |||
Sandoz | Enoxaparin Sodium Injection | Exposure to high temperatures may have impacted product effectiveness. | Sandoz, Inc. |