The Recall Desk
SevereFDA (Drugs)·D-0062-2021·Announced 2020-11-11

Metformin Hydrochloride Extended Release Tablets Recalled for NDMA Impurity

Marksans Pharma Limited is recalling Metformin Hydrochloride Extended Release tablets due to N-Nitrosodimethylamine (NDMA) impurity levels above acceptable intake limits.

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 involves a significant impurity (NDMA) above acceptable intake levels, which aligns with the rubric criteria for Severe severity (FDA Class II with significant injury/property-damage reports or structural defects, though here it is a chemical impurity risk).

Plain-English summary

Marksans Pharma Limited is recalling 368,976 bottles of Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles. The product is manufactured for Time-Cap Labs, Inc. and is distributed nationwide. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving the detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

The affected product is a prescription-only medication. Specific lot codes and expiration dates are listed in the official recall documentation, including codes such as M125E, D001F, and 9R9001. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is limited to the specific bottles and lot codes identified in the source documentation.

The recalled product

Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE EXTENDED RELEASE
Manufacturer
Marksans Pharma Limited
Category
Drug — Prescription Medication
Hazard
Affected units
368,976

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)

  • M125E Oct-20
  • D001F
  • C084F Nov-20
  • F073F
  • E063F Jan-21
  • F072F Mar-21
  • J002F
  • J087F Apr-21
  • K080F
  • L056F Jun 21
  • M046F
  • Jul-21
  • 9R9001
  • Oct-21
  • 9R9002
  • Nov-21
  • 9R0001
  • 9R0002 Dec-21
  • 9R0003
  • XR0016

UPCs (3)

  • 0349483624014
  • 0349483623109
  • 0349483623017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Marksans Pharma Limited 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 →

Related recalls

Same brand · METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Same hazard · ndma impurity

See all →