Extended-release metformin recalled due to impurity

Companies recently recalled metformin hydrochloride for extended-release oral suspension and metformin hydrochloride extended-release tablets USP due to excess amounts of N-nitrosodimethylamine.


In the past month, two companies recalled extended-release metformin due to the detection of N-nitrosodimethylamine (NDMA), a probable carcinogen.

First, Sun Pharmaceutical Industries Inc. recalled one lot of metformin hydrochloride for extended-release oral suspension (Riomet ER; 500 mg per 5 mL) due to excess amounts of NDMA, the FDA announced on Sept. 23. Seven hundred forty-seven affected cartons were distributed nationwide to wholesalers.

In the second recall, announced by the FDA on Oct. 5, Marksans Pharma Limited expanded its earlier recall initiated on June 5 to include an additional 76 unexpired lots of metformin hydrochloride extended-release tablets USP (500 mg and 750 mg). Company testing found that NDMA content in some lots exceeded the acceptable daily intake limit.