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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).

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
Brexafemme Antifungal oral medication Potential cross contamination with non-antibacterial beta-lactam drug substance Scynexis, Inc.
VistaPharm Sucralfate Oral Suspension 1g/10mL Potential contamination with Bacillus cereus Potential contamination with Bacillus cereus
Novartis Sandimunne Oral Solution (cyclosporine oral solution, USP) 100 mg/mL Crystal formation which could potentially result in incorrect dosing Novartis Pharmaceuticals Corporation
TheraBreath TheraBreath Kids Strawberry Splash Oral Rinse Device & Drug Safety/Microbial Contamination Church & Dwight Co., Inc.
WEFUN Dietary Supplement with undeclared Sildenafil Undeclared drug, Sildenafil Hua Da Trading Inc dba Wefun Inc
Marlex Pharmaceuticals, Inc. Digoxin Tablets USP, 0.125mg and 0.25mg Label Mix-Up Marlex Pharmaceuticals, Inc.
Dr. Berne’s MSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil Eye Drops; MSM MIST Drops 5% Solution Bacterial and Fungal Contamination Dr. Berne’s Whole Health Products
Numerous brand names Numerous human food, animal (pet) food, medical devices, and drug products Potential Salmonella contamination and presence of rodent activity at the distribution center & temperature abuse Inmar Supply Chain Solutions
Lupin Pharmaceuticals, Inc. Tydemy oral contraceptive Out of Specification Results Lupin Pharmaceuticals, Inc.
Cipla Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Failure to deliver the recommended dose Cipla
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