The FDA has announced the recall of seven formulations of extended-release Metformin because of contamination by the carcinogen MDNA. The recalls include:
- Bayshore Pharmaceuticals Metformin Hydrochloride Extended-Release Tablets USP, one Lot each of 500 mg (Lot #18641) and 750 mg (Lot #18657). Find details at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayshore-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended.
- Lupin Pharmaceuticals Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg, all batches. Find details at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-metformin-hydrochloride-extended.
- Granules Pharmaceuticals Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, twelve lots. Details: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/granules-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended.
- Apotex Metformin Hydrochloride Extended-Release Tablets, USP 500mg, all lots. Details: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release-tablets.
- Actavis brand (Teva Pharmaceuticals) Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg, fourteen lots. Details: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-initiates-voluntary-nationwide-recall-metformin-hydrochloride-extended.
- Time-Cap Labs (Marksans Pharma Limited) Metformin Hydrochloride Extended-Release Tablets, USP 500mg, one lot (#XP9004). Details: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marksans-pharma-limited-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release.
- Amneal Pharmaceuticals Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg, all lots. Details: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended.