WASHINGTON — Nostrum Laboratories is voluntarily recalling one lot of the diabetes drug metformin, because it may contain high levels of a cancer-causing chemical, according to a notice by the U.S. Food and Drug Administration.
The latest recall covers one lot of 750-mg extended-release metformin tablets. The announcement is an expansion of a nationwide recall Nostrum Laboratories announced in early November for two lots of the 750 mg extended release tablets.
Metformin tablets are a staple of diabetes care, reducing excess sugar in the blood. People with Type 2 diabetes use metformin alone or with other drugs to help control their blood sugar levels. More than 34 million people in the U.S. have this disease.
In May 2020, the FDA told five drugmakers to recall versions of metformin because several batches had tested positive for unsafe levels of the chemical N-Nitrosodimethylamine (NDMA). The agency had stepped up testing after the same chemical was found in dozens of shipments of heartburn drugs last year, triggering recalls of Zantac and other popular over-the-counter and prescription medications.
Since the FDA's initial notice last May, at least 10 companies have recalled metformin extended-release tablets. The agency noted previously that no contamination problems have been found in immediate-release metformin.
Patients should continue taking metformin drugs until their doctor can prescribe a replacement, the FDA said in a statement, noting the risks of discontinuing.