On June 5, the FDA announced a pair of recalls for extended-release metformin (Metformin ER®) due to the detection of a carcinogenic chemical called N-Nitrosodimethylamine (NDMA).
Marksans Pharma Limited, India recalled metformin ER (500-mg) — Lot# XP9004 — sold in 100 count bottles with NDC code 49483-623-01 and expiration date 12/2020. It was distributed by Time-Cap Labs, Inc.
Teva Pharmaceuticals USA, Inc. recalled metformin ER (500-mg and 750-mg) in 100-count and 1000-count bottles. It was distributed to Teva’s customers in the U.S. from January 8, 2019 to May 27, 2020.
The FDA recommends that patients continue taking metformin, even if it is recalled, until their doctor can prescribe a suitable replacement.
People who have used other medications that were contaminated by NDMA — such as Zantac® and valsartan — have filed lawsuits after developing a variety of types of cancer following long-term use, including breast cancer, bladder cancer, stomach cancer, and more.