Leading Pharma Recalls Furosemide Tablets
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Leading Pharma Recalls Furosemide Tablets
Leading Pharma, LLC · Class II — Moderate Risk

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.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.