Drug Safety Alerts

Granules Metformin 750 mg Tablets Consumer-Level Recall

7/05/2020

On July 5 2020, Granules Pharmaceuticals, Inc. issued a consumer-level recall of Metformin Hydrochloride Extended-Release 750 mg tablets. This recall was issued due to the presence of N-nitrosodimethylamine (NDMA) amounts above the established levels by the FDA.

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 to continue taking their medication and contact their health care professional who can prescribe a replacement. According to the United States Food and Drug Administration (FDA) it could be dangerous for patients with type 2 diabetes to stop taking their Metformin without first talking to their health care professionals. The FDA has advised that patients should continue taking Metformin tablets even after recalls occur, until they consult with their health care professional who can prescribe a replacement.

This recall includes all lots on the market of Granules Metformin HCl Extended Release Tablets, USP 750 mg. A complete list of the products affected by this recall is provided here.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Metformin Hydrochloride Extended-Release 750 mg tablets manufactured by Granules Pharmaceuticals, Inc. to contact their prescriber.

For more information, please call Inmar toll-free at 1-888-985-9117, Monday through Friday, 9:00 am to 5:00 pm (ET). You may also call the U.S. Food and Drug Administration toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at www.fda.gov.