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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 to remove a defective drug product from the market or warn patients and consumers about a potential risk.

The list below includes voluntary drug recalls in which public notification has been issued.

Visit FDA’s role in drug recalls for more information.
Visit Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.
Follow FDA Recall Information on X (formerly Twitter).



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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
Bloodline Water Based Tattoo Pigments Contaminated with high concentrations of microorganisms Sierra Stain LLC
No Brand Name Endurance Pro Energy Boost Capsules Product is tainted with sildenafil. Veata LLC
No Brand Name Boom Max Product is tainted with sildenafil. Boulla LLC
B Braun 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers Potential for particulate matter and fluid leakage of the containers B. Braun Medical Inc.
Baxter Heparin Sodium in 0.9% Sodium Chloride Injection Elevated endotoxin levels Baxter International Inc
Healthy Living Migraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets Device & Drug Safety - Mislabeling Aurobindo Pharma USA, Inc.
Umary Umary Acido Hialuronico, Suplemento Alimenticio Undeclared Drug Ingredients: Diclofenac and Omeprazole Main Products, Inc.
Hikma Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL Potential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL). Hikma Pharmaceuticals PLC
Par Pharmaceutical Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets Mislabeled with the incorrect strength on the carton Endo USA, Inc
Infla-650 Infla-650 Herbal Dietary Supplement Capsules Tainted with the drug ingredients: acetaminophen, diclofenac and phenylbutazone Guru Inc.
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