Apotex Corp is issuing a voluntarily nationwide recall for all lots of the Metformin Extended-Release Tablets (USP 500mg).
The recall was issued after Apotex was notified by the FDA that one lot tested positive for high levels of a carcinogenic chemical called N-Nitrosodimethylamine (NDMA).
Apotex extended the recall to include all lots of extended-release metformin “out of an abundance of caution.”
The company stopped selling this product in the U.S. in February 2019, and very little remains on the market. No adverse events have been reported.
Metformin is a medication that helps people with type-2 diabetes control their blood-sugar levels. NDMA contamination in metformin is particularly concerning because patients take it every day for years.
On May 28, the FDA announced that it has asked 5 pharmaceutical companies to issue voluntary recalls for extended-release metformin due to high levels of NDMA.
The FDA is asking patients to continue taking metformin even after recalls occur, until they consult with their health care professional who can prescribe a replacement.
FDA testing has not shown NDMA in immediate-release metformin.