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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
Exela Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial Vial Breakage Exela Pharma Sciences, LLC
Adam’s Polishes Hand sanitizer Presence of methanol Adam’s Polishes, LLC
Aurobindo Pharma USA, Inc. Quinapril and Hydrochlorothiazide Tablets USP, 20mg / 12.5mg, 90’s HDPE bottle Due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril Aurobindo Pharma USA, Inc.
Mylan Institutional LLC Octreotide Acetate Injection, 500 mcg/mL Due to glass particulates Mylan Institutional LLC, a Viatris company
Exela & Civica Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial Vial Breakage Exela Pharma Sciences, LLC
Golden State Medical Supply, Incorporated Clopidogrel 75mg Tablets, Atenolol 25mg Tablets Due to Label Mix-up Golden State Medical Supply, Incorporated
My Stellar Lifestyle Wonder Pill Capsules Product contains undeclared tadalafil Proper Trade LLC/My Stellar Lifestyle
Auromedics Acyclovir Intravenous Product Presence of a dark red, brown and black particulate inside the vial Eugia US LLC
Antica Farmacista Ocean Citron Hand Sanitizer Product contains benzene Salon Technologies International Inc.
Colgate Toothpaste Product was stored outside of labeled temperature requirements Family Dollar
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