Bayshore Pharmaceuticals of Short Hills, N.J., is recalling one lot of Metformin Hydrochloride Extended-Release Tablets.
Testing of the medication, used as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus, showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer). There are no reports of adverse events.
A list of the Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg lots being recalled may be found here.
What to do
Patients with questions may contact Bayshore Pharmaceuticals at (877) 372-6093.