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.

Resources for You

• Guidance for Industry: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C
• The Key Elements of Being "Recall-Ready"
• Best Practices for Drug Product Recalls
• Best Practices for Human Drug Product Recalls
• Recalls, Market Withdrawals, & Safety Alerts
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program
• Enforcement Reports
• Drug Safety Communications
• Drug Alerts and Statements
• FDA Recall Information on Twitter
• Basic Reset and Biogenyx Recalled Products

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Terminated Recall - Any -YesNo

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
09/11/2023	Novartis	Sandimunne Oral Solution (cyclosporine oral solution, USP) 100 mg/mL	Crystal formation which could potentially result in incorrect dosing	Novartis Pharmaceuticals Corporation
09/08/2023	TheraBreath	TheraBreath Kids Strawberry Splash Oral Rinse	Device & Drug Safety/Microbial Contamination	Church & Dwight Co., Inc.
09/05/2023	WEFUN	Dietary Supplement with undeclared Sildenafil	Undeclared drug, Sildenafil	Hua Da Trading Inc dba Wefun Inc
08/31/2023	Marlex Pharmaceuticals, Inc.	Digoxin Tablets USP, 0.125mg and 0.25mg	Label Mix-Up	Marlex Pharmaceuticals, Inc.
08/26/2023	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
08/23/2023	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
07/31/2023	Lupin Pharmaceuticals, Inc.	Tydemy oral contraceptive	Out of Specification Results	Lupin Pharmaceuticals, Inc.
07/07/2023	Cipla	Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation)	Failure to deliver the recommended dose	Cipla
06/14/2023	Major Pharmaceuticals	Dronabinol Capsules 2.5mg and Ziprasidone Hydrochloride Capsules 20mg	Packaging may contain incorrect product due to labeling mix-up	The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories
05/19/2023	G-SUPRESS DX	Cough Suppressant, expectorant, nasal decongestant pediatric drops	Packaging may contain incorrect product	NOVIS PR LLC

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