Contacts

Consumers

Teva’s Medical Information

druginfo@tevapharm.com

888-838-2872

Media:

Kelley Dougherty

973-832-2819

Eric Rubin

862-221-7151

FOR IMMEDIATE RELEASE – June 2, 2020 - 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

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.

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

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

  • 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 other problems experienced with the use of these products may also be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax.

This recall is being conducted with the knowledge of the FDA.

Patient safety and product quality are critical to Teva. Teva will continue to partner with, and regularly update, all relevant regulatory authorities as relevant information becomes available.

Teva Product Label

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Metformin recall label 2.jpg

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