Drug & medication recalls Moderate risk

Furosemide Tablets recalled over manufacturing violations

Recall date
March 20, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Leading Pharma, LLC recalls Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004…
Recall number
D-0486-2026
FDA classification
Class II
Brand / firm
Leading Pharma, LLC
Sold / distributed
US Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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