Drug Safety Alerts

Amneal Metformin Hydrochloride Extended-Release 500 mg tablets and 750 mg tablets - Consumer-level Recall

6/03/2020

On June 3, 2020, Amneal issued a consumer-level recall of Metformin Hydrochloride Extended-Release 500 mg tablets and 750 mg tablets. Amneal was notified by the United States Food and Drug Administration (FDA) that the agency’s testing of seven lots of Metformin Hydrochloride Extended-Release tablets, USP, 500 mg and 750 mg, showed N-nitrosodimethylamine (NDMA) amounts above acceptable levels. The FDA recommended a recall of the seven lots. Amneal has advised that it has agreed to the recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended-Release tablets, USP, 500 mg and 750 mg out of an abundance of caution.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

NDMA is classified as a probable human carcinogen based on laboratory tests. NDMA is a known environmental contaminant and is found in water and foods, including meats, dairy products, and vegetables. Metformin is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients taking Metformin Hydrochloride Extended-Release 500 mg tablets and 750 mg tablets are advised by the FDA to continue taking their medication and contact their health care professional who can prescribe a replacement. According to the FDA it could be dangerous for patients with type 2 diabetes to stop taking their Metformin without first talking to their health care professionals.

A complete list of the Amneal Metformin Hydrochloride Extended-Release 500 mg tablets and 750 mg tablets affected by this recall is here.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Metformin Hydrochloride Extended-Release 500 mg tablets and/or 750 mg tablets to contact their prescriber.

For Medical Inquiries or to report Adverse Events, or quality problems experienced with the use of this product, please contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8:00 am – 6:00 pm, EST, e-mail at DrugSafety@amneal.com or visit www.amneal.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.