FDAFDA · Food and drugs·Recall number D-0486-2026
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Published April 29, 2026 · Recall initiated: March 20, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FUROSEMIDE
- Manufacturer
- Leading Pharma, LLC
- Distributor
- US Nationwide.
- Lot
- Lots# H03125, H03225, H03325, Exp Date: 2027/08
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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