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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.

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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
CHANTIX Smoking cessation treatment N-Nitroso Varenicline content above ADI level Pfizer
Neutrogena, Aveeno Sunscreen Testing identified low levels of benzene Johnson & Johnson
Innoveix Pharmaceuticals, Inc. Injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg Potential lack of sterility assurance Innoveix Pharmaceuticals, Inc.
Teva Topotecan Injection 4 mg/4 mL (1 mg/mL) Presence of particulate matter Teva Pharmaceuticals
Limar Hand sanitizer Packaged in bottles that resemble drink containers Ardil Commercial
Prairie Wolf Distillery Hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers that resemble water bottles Packaged in containers resembling water bottles Prairie Wolf Spirits, Inc.
Durisan Hand sanitizer and hand sanitizing wipes Microbial contamination Sanit Technologies LLC d/b/a Durisan
Viona Pharmaceuticals Inc. Metformin Hydrochloride Extended-Release Tablets Contains Nitrosodimethylamine (NDMA) impurities Viona Pharmaceuticals Inc.
Imperia Elita Imperia Elita Vitaccino Coffee Undeclared Sibutramine and Fluoxetine Dash Xclusive
Medically Minded Hand Sanitizer Presence of methanol Global Sanitizers
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