Metformin Hydrochloride – Teva Pharmaceuticals Nationwide Recall


Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)

Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of 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) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020.

The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:

  • Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.
  • Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.
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

“Label, Actavis Metformin Hydrochloride Extended-Release Tablets, 500 mg, 100 tablets”

Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration, It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.

“Label, Actavis Metformin Hydrochloride Extended-Release Tablets, 750 mg, 100 tablets”

Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00 am to 5:00 pm Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at druginfo@tevapharm.com.

“Label, Actavis Metformin Hydrochloride Extended-Release Tablets, 500 mg, 1000 tablets”

Patients wishing to return product may contact Teva’s product recall processor to obtain instructions and a return kit for returning their medication:

“Label, Actavis Metformin Hydrochloride Extended-Release Tablets, 750 mg, 1000 tablets”

  • Contact Inmar at 1-855-532-1850 (Hours of Operation: 9 am to 5 pm Eastern Time, Monday – Friday) or email Inmar at: tevarecalls@inmar.com.
  • Inmar will provide the materials needed to return their medication and instructions for reimbursement.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.