FDA Recalls Brand-Name Type 2 Diabetes Drug Over Cancer Concerns

What's the issue?

The U.S. Food and Drug Administration (FDA) has issued a recall for all lots of the Type 2 diabetes drug metformin HCl extended-release tablets made by Aurobindo Pharma USA, Inc. due to the presence of a probable human carcinogen.

Which products are affected?

The recall affects 500-mg and 1,000-mg metformin HCl extended-release tablets in 100-count and 1,000-count bottles. The affected lot numbers are:

• 500 mg: AB11278, AB11454, AB11765, AB11845, AB12202
• 1,000 mg: AB11312, AB11313, AB11380, AB11453, AB11846, AB12201

What should patients do?

Patients who are taking this medication should stop taking it immediately and contact their doctor for alternative treatment options. They should return the recalled product to the pharmacy.

What's the background?

The FDA initiated the recall after testing revealed the presence of N-nitrosodimethylamine (NDMA) in the affected lots. NDMA is a probable human carcinogen, and long-term exposure to it may increase the risk of cancer.

What's the FDA doing?

The FDA is investigating the cause of the contamination and working with Aurobindo Pharma USA, Inc. to ensure that all affected products are removed from the market.

For more information

Consumers and healthcare professionals with questions can contact Aurobindo Pharma USA, Inc. at 1-866-853-3140 or by email at pvg@aurobindousa.com.