Drug Safety Alerts

Nostrum Laboratories, Inc. Metformin Hydrochloride Extended-Release 750 mg Tablets Recall

11/02/2020

On November 2, 2020, the United States Food and Drug Administration (FDA) published a notice regarding a recall of Metformin Hydrochloride Extended-Release 750 mg tablets manufactured by Nostrum Laboratories, Inc. This recall was issued because an unexpected impurity was found in these products that could be a health hazard or safety risk to plan members using product affected by this recall.

This recall affects lot numbers MET200101 exp. 05/2022 and MET200301 exp. 05/2022.

Consistent with the FDA’s guidance, to avoid interruption in therapy, you should not return the product until after you have either received a replacement product or an alternative treatment. Once you receive the replacement product or different alternative treatment you can then return the recalled product to your pharmacy.

The FDA recommends that consumers should continue taking metformin tablets even after recalls occur, until they consult with their health care professional who can prescribe a replacement or alternative treatment. Patients with type 2 diabetes could face dangerous health risks if they stop taking their prescribed metformin.

Please call your health care professional right away for advice if you may be using affected product or if you do not know if you used affected product. Your health care professional is familiar with your medical history and can suggest the best treatment option for you.

CVS Caremark® Response: If you are currently taking Metformin Hydrochloride Extended-Release 750 mg tablets manufactured by Nostrum Laboratories, Inc., please call a Customer Care representative at the toll-free number listed on your benefit ID card. We will give you more information and help with arrangements for the return and replacement of any affected product.

If you are currently taking Metformin Hydrochloride Extended-Release 750 mg tablets and have questions regarding this recall, please call your doctor or call Nostrum Laboratories, Inc. at 1-816-308-4941, Monday through Friday, 8:00 AM to 5:00 PM (CT) or email quality@nostrumpharma.com. You may also call the United States Food and Drug Administration (FDA) toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.