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

FDA recall notice · announced April 29, 2026 · Leading Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: US Nationwide.
Lot/code information: Lots# H03125, H03225, H03325, Exp Date: 2027/08
Quantity: 9384 bottles
Status: Ongoing
Products in this recall event:
- Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01 (D-0486-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.