The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1385-2020·Announced 2020-07-22

Lupin Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

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, which corresponds to a 'Severe' rating under the rubric, particularly given the presence of a known carcinogenic impurity (NDMA) above acceptable levels.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles. The recall involves 273,060 bottles of the prescription medication, which was distributed throughout the United States.

The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. The affected product is identified by NDC 68180-337-07 and includes specific batch numbers manufactured between July 2020 and January 2022.

Consumers and healthcare providers should check their inventory for the specific NDC and batch numbers listed in the recall notice. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement.

The recalled product

Product
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
273,060

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

UPCs (1)

  • 0368180337072

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by Lupin Pharmaceuticals 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 4 products in this recall →

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