The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1334-2020·Announced 2020-07-01

Lupin Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

Lupin Pharmaceuticals is recalling 6,540 bottles of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) 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 and involves the detection of a carcinogenic impurity (NDMA) above acceptable intake levels, which aligns with the rubric criteria for Severe severity.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling 6,540 bottles of Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count. The product is a prescription-only medication manufactured for Lupin Pharmaceuticals, Inc., in Baltimore, MD, and manufactured by Lupin Limited in Goa, India. The specific batch involved is # G901203 with an expiration date of 12/2020.

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

The product was distributed throughout the United States. Consumers and healthcare providers should check their inventory for the specific NDC 68180-336-07 and batch number G901203. If found, the product should be returned to the pharmacy or point of purchase for disposal or replacement.

The recalled product

Product
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
6,540

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)

  • Batch # G901203
  • exp. date 12/2020

UPCs (1)

  • 0368180337072

Distribution

Distribution scope not specified by the agency.

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