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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.

Resources for You

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
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.
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