FDAClass IIApril 29, 2026

Furosemide Tablets recall: CGMP Deviations

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

Why was Furosemide Tablets recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Recalling firm
Leading Pharma, LLC
Quantity
9384 bottles
Distribution
US Nationwide.
Recall date
April 29, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls