May 30, 2020
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 UScustomerservice@Apotex.com. 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