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CLASS II · ModerateFDA

Leading Pharma, LLC recalls Furosemide Tablets

📅 Mar 20, 2026 · 📍 Nationwide
Recalling company
Leading Pharma, LLC
Product
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Reason
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Mar 20, 2026
Reported
Apr 29, 2026
Distribution
US Nationwide.
Status
Ongoing
Quantity
9384 bottles
Lot / codes
Lots# H03125, H03225, H03325, Exp Date: 2027/08
Company location
Fairfield, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0486-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0486-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.