Impurity Found in Metformin Hydrochloride ER Tablets, USP, 500 mg and 750 mg

The U.S. Food and Drug Administration (FDA) released a statement alerting patients and health care providers that some formulations of Metformin Hydrochloride ER tablets, USP, 500 mg and 750 mg contain an impurity classified as a probable human carcinogen (a substance that could cause cancer), NDMA. Metformin Hydrochloride ER tablets are indicated for the treatment of Diabetes Mellitus, Type 2. The FDA previously tested some Metformin Hydrochloride ER products late last year and determined NDMA levels were within acceptable intake levels. Testing was continued and the FDA recently became aware of reports of higher NDMA levels in some formulations. Manufacturers Amneal Pharmaceuticals and Apotex Corporation announced a voluntary nationwide recall of their Metformin Hydrochloride ER tablets.

N-Nitrosodimethylamine (NDMA), is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables. It is classified as a probable human carcinogen based on laboratory test results. NDMA was an issue with a previous recall of certain blood pressure medications listed as Angiotensin II Receptor Blockers (ARBs) such as Losartan and Valsartan and the H2 histamine antagonist Ranitidine (Zantac).

Patients who are on Metformin Hydrochloride ER tablets, USP, 500 mg and 750 mg should not stop taking their medication until they consult with their health care professional. Discontinuing Metformin Hydrochloride ER tablets, USP, 500 mg and 750 mg without prescriber consultation could result in dangerous health risks for type 2 diabetes patients.

For further information, please see below:

The statement alerting patients and health care professionals of NDMA found in samples of metformin may be found at: https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin