The Recall Desk
HighFDA (Drugs)·D-1304-2020·Announced 2020-06-24

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

AvKARE Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk impurity (NDMA) without reported illnesses or injuries, meeting the criteria for a High severity score.

Plain-English summary

AvKARE Inc. is recalling Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, in 90, 180, and 500-count bottles. The recall involves 88,545 bottles distributed nationwide. The specific NDCs affected are 42291-611-90, 42291-611-18, and 42291-611-50.

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

Consumers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The affected lots and expiration dates are listed in the official recall notice.

The recalled product

Product
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Manufacturer
AVKARE Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
88,545

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 (20)

  • Lots: a) 23069 Exp. 11/30/2020
  • 24571 Exp. 05/31/2021
  • 25310 Exp. 07/31/2021
  • 26391 Exp. 01/31/2022
  • b) 22542 Exp. 06/30/2020
  • 23345 Exp. 11/30/2020
  • 24032 Exp. 03/31/2021
  • 24624 Exp. 07/31/2021
  • 24631 Exp. 05/31/2021
  • 25381 Exp. 08/31/2021
  • 25907 Exp. 10/31/2021
  • 26478 Exp. 01/31/2022
  • c) 22348 Exp. 06/30/2020
  • 22405 Exp. 06/30/2020
  • 22406 Exp. 06/30/2020
  • 22740 Exp. 06/30/2020
  • 23346 Exp. 11/30/2020
  • 23926 Exp. 03/31/2021
  • 24364 Exp. 05/31/2021
  • 25014 Exp. 07/31/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by AVKARE Inc. 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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