Recall: D-0486-2026

Class II - Potentially Harmful

Class IIClassification

2026-03-20Initiated

OngoingStatus

Leading Pharma, LLCFirm

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.

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.