Class II · Moderate risk Ongoing
Furosemide Tablets
Reason Presence of Foreign Substance
Furosemide Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
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
- Recalling firm
- Leading Pharma, LLC
- NDC code
- 69315-118-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0486-2026
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Furosemide recalls
See all
Class I · High risk Terminated
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection
Reason Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Class II · Moderate risk Terminated
Furosemide Tablets USP
Reason Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Class II · Moderate risk Terminated
Furosemide 20 mg/mL svn Sol
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
FUROSEMIDE Tablets USP
Reason CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
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