The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1356-2020·Announced 2020-07-01

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

Time-Cap Labs is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis found NDMA impurity above acceptable 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 with potential for adverse health consequences (such as NDMA impurity) are categorized as Severe (Score 4), as they are not Class I but involve significant health risks.

Plain-English summary

Time-Cap Labs, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets, USP 500 mg. The product is manufactured by Marksans Pharma Limited and distributed nationwide. The recall involves 11,279 bottles with lot code XP9004 and an expiration date of 12/2020.

The recall was initiated because FDA analysis detected the impurity N-Nitrosodimethylamine (NDMA) above the acceptable intake level. This is a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The product is available in 100-tablet bottles.

The recalled product

Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE EXTENDED RELEASE
Manufacturer
Marksans Pharma Limited
Category
Drug — Prescription Drug
Hazard
Affected units
11,279

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 (2)

  • XP9004
  • exp 12/2020

UPCs (3)

  • 0349483624014
  • 0349483623109
  • 0349483623017

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Same hazard · ndma impurity

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