Metformin Extended Release 500mg Recall – Apotex Corp.

May 30, 2020

After notification of any recall, Express Scripts will continue processing new and refill prescriptions with product from non-recalled lots or manufacturers, if available.

Express Scripts did NOT dispense any lots impacted by this recall.

On May 27, 2020, Apotex Corp announced a voluntary recall of all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg. Apotex was notified by the U.S. Food and Drug Administration that one lot of Metformin Hydrochloride Extended-Release Tablets was tested and showed results for NDMA, an unexpected impurity, at levels in excess of acceptable limits and recommended recall of the one tested lot. 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 Metformin Hydrochloride Extended-Release Tablets in the US.

Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information is available on the FDA's website:

Last updated: August 28, 2020

The information on this site is not intended to take the place of your doctor or other healthcare professionals. It is a resource to help you make the best decisions and get the most from the medical services available to you. A licensed physician should be consulted for diagnosis and treatment of all medical conditions.