Two drugmakers, Teva Pharmaceuticals and Marksans Pharma Limited, have voluntarily recalled their versions of metformin, a popular diabetes drug.
The two drugmakers recalled the extended-release tablets after detecting unacceptable levels of N-Nitrosodimethylamine, a probable human carcinogen.
Teva is recalling 14 lots of its metformin hydrochloride extended-release tablets in the U.S., including their 500 mg and 750 mg bottles.
Marksans Pharma Limited, which is based in India, is recalling one lot of its extended-release metformin tablet in the U.S.
The recalls come after the FDA determined May 28 that there were unacceptable levels of N-Nitrosodimethylamine in metformin extended-release tablets.
Two other drugmakers, Apotex and Amneal Pharmaceuticals have both recalled their extended-release tablets after being asked to do so by the FDA.
The agency had asked five drugmakers to voluntarily recall their products.