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:
| NDC | Product Description | Lot Number | Expiration |
|---|---|---|---|
| 62037-571-01 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count | 1329548A | 06/2020 |
| 62037-571-01 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count | 1338302M | 10/2020 |
| 62037-571-01 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count | 1348968M | 10/2020 |
| 62037-571-01 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count | 1348969M | 11/2020 |
| 62037-571-01 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count | 1348970M | 10/2020 |
| 62037-571-01 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count | 1376339M | 09/2021 |
| 62037-571-10 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count | 1323460M | 06/2020 |
| 62037-571-10 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count | 1330919M | 06/2020 |
| 62037-571-10 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count | 1338300A | 10/2020 |
| 62037-571-10 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count | 1341135M | 12/2020 |
| 62037-571-10 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count | 1391828M | 11/2021 |
| 62037-577-01 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count | 1333338M | 08/2020 |
| 62037-577-01 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count | 1333339A | 08/2020 |
| 62037-577-10 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 1000 Count | 1354471A | 02/2021 |
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.