Drug Safety Alerts

Bayshore Pharmaceutical Metformin Hydrochloride Extended-Release 500 mg and 750 mg Tablets Patient-Level Recall

8/19/2020

On August 19, 2020, Bayshore Pharmaceuticals, LLC issued a patient-level recall of certain Metformin Hydrochloride Extended-Release 500 mg and 750 mg tablets. Bayshore Pharmaceuticals, LLC advised that as part of the ongoing assessment and continuation of the dialog with the United States Food and Drug Administration (FDA), additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA) and that out of an abundance of caution, the company is recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg in the US. Bayshore Pharmaceuticals, LLC further advised that to date it has not received any reports of adverse events related to this recall.

NDMA is classified as a probable human carcinogen based on laboratory tests. NDMA is a known environmental contaminant and is found in water and foods, including meats, dairy products, and vegetables. Metformin is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients taking recalled Metformin Hydrochloride Extended-Release 500 mg tablets and 750 mg tablets are advised by the FDA to continue taking their medication and contact their health care professional who can prescribe a replacement. According to the FDA it could be dangerous for patients with type 2 diabetes to stop taking their Metformin without first talking to their health care professionals.

A complete list of the products included in this recall is can be found here.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Metformin Hydrochloride Extended-Release 500 mg and 750 mg tablets to contact their prescriber.

For more information about this recall, please call Bayshore Pharmaceuticals, LLC at 1-877-372-6093. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.