The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0061-2021·Announced 2020-11-11

Time-Cap Labs Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

Time-Cap Labs, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 500 mg because the FDA detected the impurity N-Nitrosodimethylamine (NDMA) above acceptable intake levels.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 are assigned a severity score of 4 (Severe), particularly when involving significant chemical impurities like NDMA.

Plain-English summary

Time-Cap Labs, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets USP 500 mg. The recall involves 90-count, 100-count, 500-count, and 1000-count bottles manufactured by Marksans Pharma Limited. The products are distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the FDA detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. The agency has classified this recall as Class II.

Consumers who have these specific bottles should stop using the medication and contact their healthcare provider for guidance. The affected products are identified by specific NDC codes and lot codes listed in the official recall notice.

The recalled product

Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE EXTENDED RELEASE
Manufacturer
Marksans Pharma Limited
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) 90 count: E072F
  • E074F
  • E076F Oct-20
  • D096F
  • H029F
  • H031F
  • XP8276
  • XP8289 Nov-20
  • L007F
  • J022F
  • H039F
  • Dec-20
  • J092F Jan-21
  • L055F Jun-21
  • K079F Jul-21
  • A002G
  • A003G
  • A007G Aug-21
  • A49001 Nov-21
  • A40001

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

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