← FDA ENFORCEMENT
D-0486-2026Class II

Leading Pharma, LLC

Recalling firm
Leading Pharma, LLC
Product type
Drug
Status
Ongoing
Report date
2026-04-29
Distribution
US Nationwide.
Firm state
NJ
Product quantity
9384 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
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

Code / lot info

Lots# H03125, H03225, H03325, Exp Date: 2027/08

Other recalls SPEQ maps to Risk Management & CAPA
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See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.