Bayshore Pharmaceuticals Recalls Two Lots of Metformin ER

August 20, 2020 – Bayshore Pharmaceuticals has issued a voluntary recall of one lot of Metformin Hydrochloride Extended-Release (ER) Tablets USP, 500mg, as well as one lot of Metformin Hydrochloride ER Tablets USP, 750mg. The recall is due to the detection of N-nitrosodimethylamine (NDMA) at levels above the current acceptable daily intake limit.

NDMA is a probable carcinogen (cancer-causing agent) that has been identified in several medications, including angiotensin II receptor blockers (or “sartans”), ranitidine, and metformin ER. However, the FDA advises that patients should not stop taking their metformin ER, as stopping treatment without the advice of a healthcare professional could lead to serious health issues. Metformin ER is indicated for use in combination with diet and exercise to improve blood sugar control in adults diagnosed with type 2 diabetes mellitus.

Consumers can contact Bayshore at 1-877-372-6093 with medical questions, to report an adverse event, or to report quality issues related to the recall. To return the recalled products, consumers should call Qualanex at 1-888-504-2013 to obtain instructions and a return kit. Adverse events that may be related to the use of metformin ER should be reported to the patient’s healthcare provider and can also be reported to the U.S. FDA through the MedWatch program.

Additional recall details are available on the FDA’s website.