Following several recalls for the heartburn medication ranitidine because it may contain a cancer-causing ingredient known as Nitrosodimethylamine (NDMA), above the U.S. Food and Drug Administration’s (FDA) recommendations, Apotex Corp. has recalled all lots of Metformin Hydrochloride Extended-Release Tablets because they may contain NDMA also above acceptable levels.

Apotox has recalled all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg “out of an abundance of caution” after the FDA found high NDMA levels in one lot of the medication. Metformin is a Type 2 diabetes drug that is used, in conjunction with diet and exercise, to improve blood sugar levels in adults and children, 10-years-old and older.

The recalled medication is a prescription drug that is taken orally. It can be identified by the NDC numbers on the product label, which includes 60505-0260-1. The affected Metformin was sold in 100 count bottles in a 500 mg strength. Labels of the recalled medication can be viewed here.

Apotox stopped selling the recalled medication in the U.S. in February 2019. The company said there is a limited supply of the product remaining on the market, which was distributed nationwide to warehousing chains. Apotox said it has not received any reports of adverse reactions to the recalled metformin tablets.

Consumers that have purchased the recalled metformin medication directly from Apotox should call Inmar Rx Solutions at 1-888-985-9014 (Option 1), Monday through Friday, from 9 a.m. to 5 p.m. EST to arrange for a return. Questions about the recall can be directed to Apotox at 1-800-706-5575, Monday through Friday, from 8:30 a. m. to 5 p.m. EST or by email at

Consumers that experience problems related to recalled medication should contact their healthcare provider.

Diabetics patients with NAFLD or NASH are at higher risk of developing liver cancer or cirrhosis. Pixabay