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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
Novartis Sandimmune (cyclosporine oral solution, USP) Oral Solution 100 mg/mL Due to crystallization formation Novartis Pharmaceuticals Corporation
TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal SprayPowder Presence of benzene Insight Pharmaceuticals
Noah’s Wholesale, LLC Dietary Supplement with undeclared Sildenafil Undeclared drug, Sildenafil Noah’s Wholesale, LLC
Bayer Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles Microbial contamination identified as Penicillium brevicompactum Bayer
KinderMed OTC Pain and Fever Reliever for Infants and Kids Due to Acetaminophen Instability KinderFarms, LLC
Dr. Ergin’s SugarMD Advanced Glucose Support, Dietary Supplement Undeclared Glyburide and Metformin SugarMDs, LLC
Multiple brands Lubricant Eye Drops & Multi-Symptom Eye Drops Device & Drug Safety Potential Safety Concerns Kilitch Healthcare India Limited
Multiple brands Dietary Supplements with undeclared Diclofenac Undeclared drug, Diclofenac Botanical-Be
LEADER OTC Ophthalmic Sterile Drops Insanitary manufacturing conditions Cardinal Health, Inc.
Rugby OTC Ophthalmic Sterile Drops Insanitary manufacturing conditions The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories
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