NDMA is classified as a probable human carcinogen. Exposure to this compound can increase cancer risk as well as organ and bone marrow damage, tumors, and gene mutation.

The U.S. Food and Drug Administration (FDA) has found N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) in tested lots of 500mg, 750mg and 1000mg Extended-Release Metformin tablets. Current FDA testing has not shown NDMA impurity in Immediate Release (IR) Metformin products (the most commonly prescribed type of metformin).

List updated January 7, 2021:

Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of RIOMET ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

Bayshore Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Lupin Pharmaceuticals, Inc. has recalled Metformin Hydrochloride Extended-Release Tablets 500mg and 1000mg Due to the Detection of N-nitrosodimethylamine (NDMA)

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Granules Pharmaceuticals, Inc. has recalled Metformin Hydrochloride Extended-Release Tablets 750mg Due to the Detection of N-nitrosodimethylamine (NDMA)

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg Due to the Detection of N-Nitrosodimethylamine (NDMA)

Teva Pharmaceuticals USA, Inc. has recalled Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)

Apotex Corp. has recalled Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA)

Marksans Pharma Limited has recalled Metformin Hydrochloride Extended-Release Tablets, USP 500mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

Amneal Pharmaceuticals LLC has recalled Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity

There are additional manufacturers of the Metformin ER formulation that supply a significant portion of the U.S. market, and their products are not being recalled. The FDA is continuing to work closely with manufacturers to ensure appropriate testing. Assessments are underway to determine whether Metformin ER recalls will result in shortages and the agency will work closely with manufacturers to prevent mor reduce any impact of shortages.

More on Recent NDMA Contamination & Recalls

Recently the FDA ordered the popular heartburn drug Zantac, and other ranitidine generics, be pulled from the market immediately, citing an unacceptable level of NDMA impurity.

FDA Press Announcement regarding NDMA Contamination and Ranitidine removal from the US Market.

NDMA contamination has been triggering warnings and recalls on multiple drugs. At Terrell • Hogan we strive to keep you informed. Reviewing medication recalls and regularly consulting with a healthcare professional is a good idea when taking prescription drugs.

See our previous article regarding NDMA recalls in Ranitidine and Nizatidine here.