FDA Announces Five Companies Are Recalling Diabetes Drugs Over Carcinogen Concerns


Two weeks after announcing concerns about high-levels of carcinogens in popular diabetes drugs, the U.S. Food and Drug Administration (FDA) announced the first voluntary recalls of this class of drugs manufactured by five companies.

On Thursday, the FDA said Apotex, Amneal, Marksans, Lupin and Teva have announced recalls of some lots of extended-release metformin medications due to the presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the regulatory agency. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. In large amounts, NDMA can cause health severe problems.


Last month, the FDA announced that high levels of NDMA had been discovered in some of the ER metformin medications it had tested. High levels of NDMA have previously led to the recall of some hypertension and heartburn medications.

Metformin, a generic medication taken by type 2 diabetes patients to control high blood sugar, is manufactured by numerous companies. Last year, there were approximately 21 million prescriptions issued for the extended-release version of the medication, which accounted for about one-fourth of all metformin prescriptions in the United States. Metformin is the fourth most-prescribed drug in the U.S.

The FDA first began investigating high levels of NDMA in metformin products in December. That followed the discovery of the impurities in the heartburn and blood pressure medications. In February, the FDA said it had not seen high levels of the carcinogen in the diabetes drug sold in the United States. Other regulatory agencies, including the European Medicines Agency and Singapore’s FDA, issued recalls over the contaminants. However, last month, the FDA reported it had found those high levels, which prompted the recall.

In its announcement Thursday, the FDA noted that all lots of ER metformin drugs manufactured by Apotex and Amneal were under voluntary recall. Marksans, labeled as Time-Cap, was recalling one lot of its drug, XP9004, as was Lupin, G901203. Teva, labeled as Actavis, was issuing a voluntary recall of 14 lots of ER metformin drugs, the FDA said.

“There are additional companies that manufacturer ER metformin and supply a significant portion of the U.S. market, whose products are not being recalled at this time,” the FDA said in its announcement.

The FDA said it is asking all companies that manufacture ER metformin and sell the drug within the United States to evaluate the risk of their products that contain NDMA above the acceptable limits and to test at-risk products before each batch is released in the U.S. market. If testing shows NDMA above the acceptable intake limit, the companies must inform the agency and should not release that batch in the United States, the regulatory agency said.

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