Nostrum Laboratories voluntarily recalls diabetes med over carcinogen concerns

Nov. 3, 2020

Missouri-based Nostrum Laboratories have announced it will be voluntarily recalling two lots of metformin tablets because samples were discovered with high levels of carcinogen nitrosamine. The metformin HCl extended release tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020.

According to the FDA, NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. Nostrum Laboratories has not received any reports of adverse events related to this recall.

The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01.

Nostrumis notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have the affected product which is being recalled should return to place of purchase. Consumers should consult a healthcare professional to obtain a replacement or a different treatment option.

Read the FDA release