Drug Safety Alerts

Apotex Metformin Consumer-Level Recall

6/05/2020

Hydrochloride Extended-Release 500 mg tablets NDC # 60505-0260-01. This recall was issued because Apotex 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). Apotex Corp has advised that it has agreed to recall this lot, and that out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the USA. NDMA is classified as a probable human carcinogen based on laboratory tests.

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

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. 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. 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.

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 recalled Metformin Hydrochloride Extended-Release tablets to contact their prescriber.

For more information about this recall, please contact Apotex at 1-800-706-5575, Monday through Friday, 8:30 am to 5:00 pm (ET) or visit https://www1.apotex.com.

You may also contact the FDA at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.