Drug Safety Alerts

Major Metformin Consumer-Level Recall

7/02/2020

On July 2, 2020, Major announced a consumer-level recall of Metformin Hydrochloride Extended-Release 500 mg tablets NDC # 00904-5794-61 manufactured by Apotex and distributed under the Major label in the United States. This recall was issued because Apotex Corp. was notified by the United States Food and Drug Administration (FDA) that one lot of Metformin Hydrochloride Extended-Release tablets, USP was tested and showed results for N-nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). According to Major and Apotex, Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of its Metformin Hydrochloride Extended-Release Tablets in the USA.

This recall affects lot number T-02134 exp. 09/30/2020.

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. 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.

CVS Caremark Response:

CVS Caremark does not carry Metformin Hydrochloride Extended-Release 500 mg tablets distributed by Major.

For more information about this recall, please contact Major Pharmaceuticals at 1‑800-616-2471 or visit www.majorpharmaceuticals.com/home. You may also contact the United States Food and Drug Administration (FDA) 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.