Agency classClass IIOur severity:Severe FDA (Drugs)·D-1384-2020·Announced 2020-07-22

Lupin Recalls Metformin Hydrochloride Extended-Release 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 agency classification is FDA Class II, and the presence of NDMA impurity above acceptable intake levels in a prescription drug constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles. The product is a prescription-only medication manufactured by Lupin Limited in Goa, India, and distributed throughout the United States.

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 affected batches include G808293, G808284, G808285, G808343, G901201, G901202, G906915, G906913, G906914, G002135, and G002849.

Consumers with this medication should contact their healthcare provider for guidance on alternative treatment options. The total quantity recalled is 59,568 bottles.

The recalled product

Product: METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Brand: METFORMIN HYDROCHLORIDE
Manufacturer: Lupin Pharmaceuticals Inc.
Category: Drug — Prescription Drug
Hazard: ndma-impurity
cgmp-deviation
Affected units: 59,568

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 →

Same brand · METFORMIN HYDROCHLORIDE

Moderate
Metformin Hydrochloride Extended-Release Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2025-04-16
High
Metformin Hydrochloride Extended-Release Tablets Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2025-04-02
Severe
Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination
FDA (Drugs) · 2022-02-02
High
Metformin Hydrochloride Tablets Recalled for NDMA Contamination
FDA (Drugs) · 2021-06-30
Moderate
Sun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Substance
FDA (Drugs) · 2021-05-19

Same manufacturer · Lupin Pharmaceuticals Inc.

See all →

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High
Prednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
High
Liraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
Moderate
Ganirelix acetate injection recalled after failing an impurity specification
FDA (Drugs) · 2025-12-17

Same hazard · ndma impurity