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WarningRecall #D-0486-2026Drug / Pharmaceutical

Leading Pharma Recalls Furosemide Tablets

Leading Pharma, LLC · Class II — Moderate Risk

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
An assortment of pharmaceutical pills (representative file photo). Specific recalled product: see recall details below. Photo: Michael Nutt / Wikimedia Commons (CC BY-SA 2.0).

Product Description

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01

Reason for Recall

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

FDA Classification

Class II — Moderate Risk

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.

Distribution

US Nationwide.

Remedy

Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.

411 Press Analysis

The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Leading Pharma, LLC initiated the recall on March 20, 2026 affecting 9384 bottles. CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. The product was distributed in US Nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Leading Pharma, LLC for further instructions.

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