The Recall Desk
SevereFDA (Drugs)·D-1331-2020·Announced 2020-07-01

Teva Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected the impurity NDMA above acceptable intake levels.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or hospitalization reports are Severe. While no specific injuries are reported in the text, the presence of a carcinogenic impurity (NDMA) above acceptable levels in a chronic medication warrants a higher severity rating consistent with the Class II classification and potential for serious long-term harm.

Plain-English summary

Teva Pharmaceuticals USA is recalling specific bottles of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg. The affected products are 100-count and 1,000-count bottles distributed throughout the United States, including Puerto Rico. The recall involves specific lot numbers and expiration dates listed in the official recall notice.

The recall was initiated because FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice. If the medication matches the recalled lots, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • a) 1329548A
  • exp. date 06/2020 1338302M
  • exp. date 10/2020 1348968M
  • exp. date 10/2020 1348969M
  • exp. date 10/2020 1348970M
  • exp. date 11/2020 1376339M
  • exp. date 09/2021 b) 1323460M
  • exp. date 06/2020 1330919M
  • exp. date 6/2020 1338300A
  • exp. date 10/2020 1341135M
  • exp. date 12/2020 1391828M
  • exp. date 11/2021

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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