The Recall Desk
SevereFDA (Drugs)·D-0056-2021·Announced 2020-11-11

Denton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

Denton Pharma, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg due to the detection of N-Nitrosodimethylamine (NDMA) impurity 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. Per the rubric, FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe; while no specific injuries are reported here, the presence of a carcinogenic impurity (NDMA) above acceptable levels in a Class II drug recall aligns with the Severe tier for significant potential harm.

Plain-English summary

Denton Pharma, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle. The product is identified by NDC 70934-334-30 and was repackaged by Northwind Pharmaceuticals. The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving the detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level, as determined by the manufacturer.

The affected lots include N107411901, N107411903, N107411904, N107411905, N107411906 (exp 11/30/2020); N107411907, N107412001 (exp 4/30/2021); N107412002, N107412004 (exp 11/30/2021); and N107412003 (exp 7/31/2021). The distribution pattern is listed as Indiana - Nationwide.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for guidance on alternative treatment options. The recall is classified as FDA Class II.

The recalled product

Product
Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
Manufacturer
Denton Pharma, Inc.
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 (14)

  • N107411901
  • N107411903
  • N107411904
  • N107411905
  • N107411906
  • exp 11/30/2020
  • N107411907
  • N107412001
  • exp 4/30/2021
  • N107412002
  • N107412004
  • exp 11/30/2021
  • N107412003
  • exp 7/31/2021

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Denton Pharma, 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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