Reported Apr 29, 2026 · Ongoing

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ…

Leading Pharma, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Leading Pharma, LLC · 3 Oak Rd · Fairfield, NJ · 07004-2903

Is this the product you have?

  • Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only
  • Manufactured byLeading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Lot codes and dates
    • Lots# H03125
    • H03225
    • H03325
  • Exp Date2027/08
Amount recalled
9384 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.