Date: 22-Aug-2020

Metformin Recalls Continue As Bayshore Pulls Diabetes Drug On Carcinogen Scare

After finding high levels of a probable carcinogen in samples of the common diabetes med metformin, the FDA has scrambled to get affected lots out of consumers' hands. Now, the agency has spotted a sixth drugmaker with a contaminated version of the drug.


New Jersey-based Bayshore Pharmaceuticals has voluntarily recalled one lot each of its 500- and 750-milligram extended-release metformin after the FDA found high levels of probable carcinogen N-nitrosodimethylamine (NDMA) in tested samples.

The recalled lots were manufactured by Beximco Pharmaceuticals in Dhaka, Bangladesh, in June 2019 for U.S. distribution, the FDA said Thursday. Bayshore was notified of possible NDMA contamination after FDA testing found abnormally high levels of the carcinogen in a sampled lot of the drugmaker's generic metformin. Bayshore then conducted its own testing on eight lots of the drug that used the same active pharmaceutical ingredients as the failed lot.

With those tests, Bayshore identified two lots that showed high NDMA levels and launched a voluntary recall. Both Bayshore and Beximco say they have not been notified of any side effects.

Bayshore is the most recent drugmaker to pull its version of metformin off shelves after FDA investigators identified high levels of NDMA, the compound also linked to global recalls of heartburn med Zantac and a range of "sartan"-based high blood pressure drugs.

The FDA began requesting voluntary recalls of certain metformin products in May after internal testing contradicted the agency's earlier findings of normal NDMA levels in tested samples.