FDA Expands Recall Of Diabetes Drug Metformin

Last week, the U.S. Food and Drug Administration announced it was expanding a June recall of the popular diabetes drug Metformin.

The drugs are being recalled for containing an unsafe level of cancer-causing agent N-Nitrosodimethylamine. The recall now includes an additional 76 unexpired lots.

Metformin is used in patients with type 2 diabetes to lower blood glucose levels.

The drugs are marketed as “extended-release tablets” under the brand name Time-ap Labs, Inc. The recall applies to metformin tablets between 500 mg and 750 mg. According to the announcement, the 500 mg pills are debossed with “101” on one side, and the 750 mg pills are debossed with “102” on one side. 

Marksans Pharma Limited, the manufacturer of the recalled medication, after performing “N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day.” According to the release, NDMA is classified as a probable human carcinogen.

The FDA is advising patients taking the pills to continue taking the recalled medicine until they can obtain a replacement from their doctor. 

 “It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional,” the FDA cautions.