Agency classClass IIOur severity:Severe FDA (Drugs)·D-1382-2020·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 NDMA impurity above acceptable intake 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, which corresponds to a Severe severity score (4) under the rubric, particularly given the detection of a carcinogenic impurity (NDMA) above acceptable levels.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 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 because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. The affected product includes 64,344 bottles with specific batch numbers and expiration dates ranging from August 2020 to February 2022.

Consumers and healthcare providers should check their inventory for the specific NDC numbers and batch codes listed in the recall notice. Patients should consult their healthcare provider for alternative treatment options if they are currently taking the affected medication.

The recalled product

Product: METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Brand: METFORMIN HYDROCHLORIDE
Manufacturer: Lupin Pharmaceuticals Inc.
Category: Drug — Prescription Drug
Hazard: ndma-impurity
carcinogen-exposure
Affected units: 64,344

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 →

Moderate
Lupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
FDA (Drugs) · 2026-09-02
Severe
Glucagon Emergency Kit Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2026-07-08
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