Drug Safety Alerts

Teva Metformin Hydrochloride Extended-Release 500 mg Tablets and 750 mg Tablets Consumer-Level Recall

6/02/2020

On June 2, 2020, Teva issued a consumer-level recall of Metformin Hydrochloride Extended-Release 500 mg tablets and 750 mg tablets that were distributed in the United States under the Actavis Pharma label. This recall was issued due to the detection of N-nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).

This could be a health hazard or safety risk to patients 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 United States Food and Drug Administration (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. 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.

A complete list of the Teva Metformin Hydrochloride Extended-Release 500 mg tablets and 750 mg tablets affected by this recall is provided 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 more information about this recall], please contact Teva Medical Information at 1-888-838-2872, Monday through Friday, 9:00 am to 5:00 pm (ET) or visit https://www.tevausa.com.

You may also contact the FDA at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at www.fda.gov.