FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Drug · Recalled April 29, 2026

Furosemide Tablets recall — Leading Pharma, LLC

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0486-2026
Brand
Leading Pharma
Classification
Class II
Units affected
9384 bottles
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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

Affected products

Companies & origin

Recalling firm location
Fairfield, NJ, United States
Firm address
3 Oak Rd, N/A, 07004-2903

Identifying details (verbatim from the notice)

Product codes / lots
Lots# H03125, H03225, H03325, Exp Date: 2027/08
Distribution
US Nationwide.
Firm notified the public via
Letter
FDA event ID
98628
Recall initiated
March 20, 2026
FDA classified
April 21, 2026
FDA report date
April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

Report a data error on this page