Diabetes Drug Metformin Recalled Over High Levels Of Cancer-Causing Ingredient

In another diabetes drug recall, Bayshore Pharmaceuticals has recalled certain Metformin tablets because they may contain N-Nitrosodimethylamine (NDMA) – a cancer-causing ingredient – in levels that are above the acceptable daily intake limit set by the FDA.

The recall affects one lot of Metformin Hydrochloride Extended-Release tablets sold in 500 mg doses and 1,000 count bottles. The medication has an NDC number of 76385-128-10 and a lot number of 18641. Expiration date is May 2021.

Also affected by the recall are Metformin Hydrochloride Extended-Release tablets sold in 750 mg doses and 100 count bottles. This medication has an NDC number of 76385-129-01 and a lot number of 18657. Expiration date is May 2021.

The tablets were manufactured by Beximco Pharmaceuticals Limited in Bangladesh in June 2019 and distributed by Bayshore Pharmaceuticals. The medication is used to improve blood sugar control in adults who have Type 2 diabetes mellitus. Labels of the drug can be viewed here.

Patients who take the affected metformin tablets are advised to continue taking their medication and contact their healthcare provider or pharmacist for an alternative treatment option. It could be more dangerous for patients to stop taking the recalled medication without talking to their healthcare provider first, the FDA said.

Questions about the recall can be directed to Bayshore Pharmaceutical at 1-877-372-6093. To return the diabetes medication, patients should call Qualanex to obtain instructions and a return kit at 1-888-504-2013.

Bayshore Pharmaceuticals was notified of the issue during testing of one lot of the diabetes drug. The company issued the recall “out of an abundance of caution” and said it has not received any reports of adverse effects related to the medication.