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Teva Pharmaceuticals recalls Metformin Hydrochloride Extended-Release Tablets

The medication may be contaminated with a probable cancer-causer

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Photo source: FDA
Teva Pharmaceuticals USA is recalling 14 lots of Metformin Hydrochloride Extended-Release Tablets.

The product, used as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients with type 2 diabetes mellitus, showed test results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer)

The following products, in USP 500 mg and 750 mg doses, are being recalled:

NDCProduct DescriptionLot NumberExpiration
62037-571-01Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count1329548A06/2020
62037-571-01Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count1338302M10/2020
62037-571-01Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count1348968M10/2020
62037-571-01Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count1348969M11/2020
62037-571-01Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count1348970M10/2020
62037-571-01Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count1376339M09/2021
62037-571-10Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count1323460M06/2020
62037-571-10Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count1330919M06/2020
62037-571-10Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count1338300A10/2020
62037-571-10Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count1341135M12/2020
62037-571-10Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count1391828M11/2021
62037-577-01Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count1333338M08/2020
62037-577-01Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count1333339A08/2020
62037-577-10Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 1000 Count1354471A02/2021

The Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, are white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.

The Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, are light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.

The recalled products were distributed nationwide as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019, and May 27, 2020.

What to do

Patients taking the recalled medications are advised to continue taking them and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Consumers with medical-related questions who wish to report an adverse event, or quality issues about the products may contact Teva Medical Information at (888) 838-2872, option 3, then, option 4 Monday – Friday, 9:00 am -- 5:00 pm (ET), or by email at druginfo@tevapharm.com.

Patients wishing to return the product may contact Teva’s product recall processor at (855) 532-1850 9 am to 5 pm (ET) Monday – Friday or by email at Inmar at tevarecalls@inmar.com. Inmar will provide the materials needed to return the products and instructions for reimbursement.