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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.

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

Recall at a glance

Quantity recalled
9384 bottles

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

Strength
80 mg
NDC / UPC
NDC 69315-118-01

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification