The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1383-2020·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, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported in the text, the presence of a carcinogenic impurity (NDMA) above acceptable levels in a Class II drug recall aligns with the Severe criteria for significant potential harm.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles. The product is prescription-only and was distributed throughout the United States. The recall involves 95,886 bottles with specific batch numbers listed in the source data.

The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. This is classified as a Current Good Manufacturing Practice (CGMP) deviation. The agency classification for this recall is Class II.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product is manufactured for Lupin Pharmaceuticals, Inc. and manufactured by Lupin Limited, Goa INDIA.

The recalled product

Product
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
95,886

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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