Recall
FDAHealthMarch 20, 2026

Leading Pharma, LLC — 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 20, 2026

US Nationwide.

What's affected?

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

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 9384 bottles.

View original FDA notice →

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