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Furosemide Tablets, USP 80 mg
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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.

Posted
Updated
Recall No.
D-0486-2026
Agency
Firm
Leading Pharma, LLC
Recall ID
98628
Status
ONGOING

Why it was recalled

Leading Pharma, LLC is recalling Furosemide Tablets, USP, 80 mg, 100-tablet bottles (NDC 69315-118-01) due to the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit, a result of current good manufacturing practice (CGMP) deviations.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

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

Recall #
D-0486-2026

Where it was sold

Distributed nationwide.

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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