The Recall Desk
SevereFDA (Drugs)·D-1305-2020·Announced 2020-06-24

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

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

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 presence of NDMA, a potential carcinogen, above acceptable intake levels constitutes a significant health risk warranting a Severe rating.

Plain-English summary

AvKARE Inc. is recalling Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, in various bottle counts (50, 90, 180, 360, and 1000 count). The recall involves approximately 1,586,913 bottles distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level in the affected products.

Consumers should check their medication for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, patients should stop using it and contact their healthcare provider or pharmacist for a replacement or further instructions.

The recalled product

Product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulas
Manufacturer
AVKARE Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
1,586,913

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) 23537 Exp. 06/30/2020
  • 23613 Exp. 06/30/2020
  • 24083 Exp. 06/30/2020
  • 24291 Exp. 06/30/2020
  • 24725 Exp. 06/30/2020
  • 25637 Exp. 06/30/2021
  • 25751 Exp. 07/31/2021
  • b) 22073 Exp. 06/30/2020
  • 22460 Exp. 07/31/2020
  • 22539 Exp. 09/30/2020
  • 22540 Exp. 09/30/2020
  • 23299 Exp. 01/31/2021
  • 23300 Exp. 01/31/2021
  • 23484 Exp. 01/31/2021
  • 23917 Exp. 03/31/2021
  • 24477 Exp. 06/30/2021
  • 24514 Exp. 06/30/2021
  • 24945 Exp. 08/31/2021
  • 25591 Exp. 10/31/2021
  • 25590 Exp. 10/31/2021

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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