June 8, 2020 — Marksans Pharma Ltd., India has voluntarily recalled extended-release metformin after FDA tests found high levels of a cancer-causing chemical.
The recall involves the diabetes drug metformin ER (500-mg) — Lot# XP9004 — in 100 count bottles with NDC code 49483-623-01 and expiration date 12/2020. It was distributed by Time-Cap Labs, Inc.
The FDA is recommending that patients keep taking their metformin, even if it has been recalled, until they can talk to their doctor about prescribing a replacement.
NDMA has been detected in other types of metformin ER, including medicines distibuted by Teva Pharmaceuticals, Amneal Pharmaceuticals, Apotex Corp., and other drug-makers.
Lawsuits have been filed by people who developed cancer after long-term exposure to NDMA in other medicines, such as Zantac® heartburn drugs and Valsartan blood pressure drugs.
NDMA is a chemical that is believed to cause cancer in humans. A growing number of lawsuits allege that NDMA exposure can cause breast cancer, bladder cancer, stomach cancer, and more.