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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
Sagent Levetiracetam Injection Lack of sterility assurance Sagent Pharmaceuticals, Inc.
American Screening Hand Sanitizer Hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption American Screening LLC
Odor-Eaters® Oder Eaters spray products Due to the presence of benzene Odor-Eaters®, owned by Blistex Inc.
SterRx, LLC SterRx products intended to be sterile Lack of sterility assurance SterRx, LLC
artnaturals Scent Free Hand Sanitizer Due to Presence of Impurities artnaturals
CUBICIN Daptomycin for injection 500mg Product contains particulate matter identified as glass Merck
Bryant Ranch Prepack Methocarbamol 500mg Bottles labeled as Methocarbamol 500mg tablets were found to contain Methocarbamol 750mg tablets. Bryant Ranch Prepack
Lupin Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg API batches above the specification limit for the impurity, N-nitrosoirbesartan Lupin Pharmaceuticals, Inc.
Teligent Pharma, Inc. Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) Super Potent Teligent Pharma, Inc.
Lotrimin® AF and Tinactin® Over the Counter (OTC) antifungal spray products Presence of benzene Bayer U.S. LLC
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