Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01

Recall Number: D-0486-2026

Firm: Leading Pharma, LLC

Classification: Class II

Status: Ongoing

Report Date: 20260429

Initiation Date: 20260320

Termination Date:

Reason for Recall

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

Product Description

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01