The Recall Desk
SevereFDA (Drugs)·D-0057-2021·Announced 2020-11-11

Denton Pharma Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

Denton Pharma, Inc. is recalling specific bottles of Metformin Hydrochloride Extended-Release Tablets 500 mg because they contain N-Nitrosodimethylamine (NDMA) above acceptable 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, which corresponds to a Severe severity score (4) under the rubric, particularly given the presence of a potential carcinogen (NDMA) above acceptable levels.

Plain-English summary

Denton Pharma, Inc. is recalling specific bottles of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg. The affected products are available in 30, 60, 90, and 120-count bottles and were repackaged by Northwind Pharmaceuticals in North Blenheim, NY. The recall involves specific lot numbers and expiration dates ranging from October 2020 to September 2021.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer detected the presence of the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. NDMA is a potential carcinogen that is strictly regulated in pharmaceutical products.

The affected products were distributed nationwide, including in Indiana. Consumers and healthcare providers should check their inventory for the specific NDC codes and lot numbers listed in the recall notice. If the product matches the recalled lots, it should be discontinued and returned to the pharmacy or distributor for disposal or credit.

The recalled product

Product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, N
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 (20)

  • a) 30 count: N107051905
  • exp 10/31/2020
  • N107052002
  • N107052005
  • exp 9/30/2021 b) 60 count: N107051907
  • N107052001 6/30/2021
  • N107052010
  • N107052008
  • N107052004
  • exp 9/30/2021
  • c) 90 count: C107051908
  • C107052002
  • C107051909 exp 6/30/2021
  • C107052001
  • exp 12/31/2020
  • C107052004
  • N107052006
  • N107052007
  • N107052009
  • N107052011

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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