FDA pushes metformin recalls for 5 drugmakers after carcinogen contamination

FDA Building 2
The FDA previously found low levels of NDMA in tested metformin that it said did not necessitate recalls. (FDA)

After the FDA identified a likely carcinogen in samples of the broadly used diabetes med metformin, recalls appeared likely. Now it's official.

The FDA said Thursday it had asked five metformin manufacturers to pull their extended-release metformin products, after pushing recalls of heartburn med Zantac and "sartan" blood pressure drugs for the same reason. A likely human carcinogen, N-Nitrosodimethylamine (NDMA), was discovered in samples of all three. 

The FDA said it was working with drugmakers to determine whether the recommended recalls would cause a shortage in the U.S. The move doesn't apply to metformin's immediate-release formulation, and the FDA specified that "there are additional manufacturers of the metformin ER formulation that supply a significant portion of the U.S. market, and their products are not being recalled."

Featured Webinar

How to Streamline Your Clinical Research Organization's Processes End to End

Learn how implementing one platform leads to data consistency and ultimately facilitate faster clinical trials while reducing overall trial costs, leave behind spreadsheets and home-grown tools for a predictable trial and the ability to forecast unit delivery resulting in the optics you need to ensure a successful trial, and hear experts share industry trends of what is affecting the Clinical Research Organization industry today.

The five firms that have been contacted are Apotex, Actavis, Amneal, Lupin and Marksans. Both Amneal and Apotex have announced voluntarily recalls of their versions of extended-release metformin.

The recall announcement comes just hours after the FDA declined to say whether it would pursue voluntary recalls after discovering NDMA contamination in tests metformin samples. 

RELATED: FDA finds likely carcinogen in common diabetes drug metformin. Will recalls follow?

Suggested Articles

Three facts about how distributors are managing in-demand inventory.

Novartis’ latest campaign with a celebrity dance partner asks people to bust a move to raise awareness around sickle cell anemia and therapy Adakveo.

Purdue has reached an $8 billion settlement with the U.S. government to settle criminal and civil charges for its role in the U.S. opioid crisis.