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DRUG RECALLMODERATE
Furosemide Tablets, USP 80 mg
Leading Pharma is recalling Furosemide Tablets 80 mg (NDC 69315-118-01) due to N-nitroso-Furosemide above recommended limits.
What to do
Do not use this medication. Contact your pharmacy or healthcare provider immediately for a replacement or alternative treatment. Return the recalled product to your pharmacy.
Why it was recalled
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
How to identify it
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Where it was sold
Distributed in US.
Official source
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Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification