The US Food and Drug Administration has published a voluntary recall announced by Nostrum Laboratories on Monday. The notice expands the number of Metformin HCl Extended-Release Tablets recalled over potentially high levels of a probable human carcinogen called N-Nitrosodimethylamine, more commonly referred to as ‘NDMA.’
We saw multiple metformin recalls throughout 2020, all of them over potentially high NDMA levels, raising concerns about cancer risk in patients who take the medication over a long period of time. Metformin is most commonly prescribed as part of the treatment for type-2 diabetes.
The original Nostrum Laboratories recall was issued on November 2, 2020; this new recall is an expansion of that one, covering the Metformin HCl Extended-Release Tablets in USP 750mg dosage. According to the recall notice, the recalled tablets are off-white and oblong with a debossed ID ‘NM7.’
The lot number, NDC, and expiration dates can be found on the FDA’s website. Nostrum notes that the tablets were distributed across the US to wholesalers; these distributors are being notified of the recall and the company is arranging for the drug to be returned.
As with previous metformin recalls, the company notes that patients who are taking these recalled tablets should speak with their health care professional about getting a replacement and continue taking the drug until advised differently. The reason, of course, is that uncontrolled diabetes is very dangerous.