FDA recall D-0486-2026

Leading Pharma, LLC · Class II · drug

Product

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

Reason for recall

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

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2026-03-20
Report date
2026-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0486-2026