The FDA on June 11 announced another recall of metformin due to excess levels of N-nitrosodimethylamine (NDMA).
Viona Pharmaceuticals Inc. recalled two lots of metformin hydrochloride extended-release tablets USP (750 mg) to the retail level due to levels of NDMA impurities above acceptable daily limits. The product was manufactured in November 2019 by Cadila Healthcare Limited in India for U.S. distribution by Viona Pharmaceuticals Inc. Affected products were distributed nationwide to distributors. No related adverse events have been reported.