The diabetes drug metformin hydrochloride has been recalled because it contains excess levels of a cancer-causing agent, the US Food and Drug Administration announced this week.
The drug’s manufacturer, Marksans Pharma Limited, has expanded a recall initially announced in June to now include an additional 76 unexpired lots of the medication.
The recalled drugs are marketed as “extended-release tablets” under the brand name Time-Cap Labs, Inc.
The drug helps lower the blood glucose levels of those with type 2 diabetes.
But the recalled product contained an unacceptably high level of N-Nitrosodimethylamine, which is considered a probable human carcinogen.
“Marksans performed 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,” the FDA outlined in its announcement.
“Therefore, out of an abundance of caution, an additional 76 lots are being recalled.”
The recall applies to metformin tablets between 500 mg and 750 mg.
The 500 mg tablets are debossed with “101” on one side; the 750 mg tablets are debossed with “102” on one side, the agency said.
The FDA advises users to continue taking the recalled tablets until a medical professional provides a replacement or alternative treatment option.
“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 said in a statement.
Consumers “should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.”