HIGH

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

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

Quick Facts at a Glance

Recall Date
March 20, 2026
Hazard Level
HIGH
Brands
FUROSEMIDE, Leading Pharma, LLC
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Leading Pharma, LLC or your healthcare provider for guidance. Notification method: Letter

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Full Description

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01. Generic: FUROSEMIDE; Brand: FUROSEMIDE. Reason: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.. Classification: Class II. Quantity: 9384 bottles. Distribution: US Nationwide.

Safety Guide

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Product Classification

Product Details

Model Numbers
Lots# H03125
H03225
H03325
Exp Date: 2027/08
UPC Codes
69315-116
69315-117
69315-118
+6 more
Affected States
ALL
Report Date
April 29, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE