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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
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
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