Use caution Drug recall · FDA · Published March 20, 2026

Leading Pharma Recalls Furosemide 80mg Due to Impurity

Leading Pharma, LLC recalls 9,384 bottles of Furosemide Tablets, USP, 80 mg due to CGMP deviations and presence of N-nitroso-Furosemide above limits.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0486-2026Drug Leading Pharma ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmLeading Pharma, LLC3 Oak Rd · Fairfield, NJ 07004-2903

✎ GovInfoNow plain-language explainer

Leading Pharma, LLC is recalling Furosemide Tablets, USP, 80 mg because of Current Good Manufacturing Practice (CGMP) deviations. The recall addresses the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. This specific issue affects bottles distributed nationwide in the United States. Read more at govinfonow.com/recall/31399-leading-pharma-recalls-furosemide-80mg-due-to-impurity.

Source Summary by GovInfoNow · govinfonow.com/recall/31399-leading-pharma-recalls-furosemide-80mg-due-to-impurity · Updated October 9, 2026 · FDA enforcement record: FDA #D-0486-2026

Cite this page

“Leading Pharma Recalls Furosemide 80mg Due to Impurity.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31399-leading-pharma-recalls-furosemide-80mg-due-to-impurity. Based on FDA recall #D-0486-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0486-2026%22&limit=1).

The FDA announced on March 20, 2026, that Leading Pharma, LLC is recalling Furosemide Tablets, USP, 80 mg due to CGMP deviations and the presence of N-nitroso-Furosemide above recommended limits. The recall affects 9,384 bottles distributed nationwide.

How to tell if you have it

Brand: Leading Pharma
Product: Furosemide Tablets, USP, 80 mg, 100 Tablets bottles
NDC: 69315-118-01
Lots: H03125, H03225, H03325
Expiration Date: 2027/08

The hazard

The recall is due to CGMP deviations and the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. The record does not report specific incidents or injuries associated with this recall.

Context

GovInfoNow's records show Leading Pharma, LLC has two other recalls on record since September 28, 2017. Other recent recalls of similar products include Unichem Bisoprolol/Hydrochlorothiazide Tablets Recall (January 21, 2026) and Wells Pharma Fentanyl Citrate Injectable Solution Recall (April 1, 2026).

How to tell if you have this one

Check your medication bottles for the brand Leading Pharma, LLC and NDC 69315-118-01. Verify the lot numbers are H03125, H03225, or H03325 with an expiration date of 2027/08. The product contains 100 tablets per bottle.

Brand
Leading Pharma
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Verify if your Furosemide Tablets, USP, 80 mg match the recalled NDC and lot numbers (H03125, H03225, H03325).
Consult Your Pharmacist
Contact your healthcare provider or pharmacist immediately to discuss the recall and obtain guidance on replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 40 days after the firm started it.

Mar 20, 2026Firm started the recall
Apr 21, 2026FDA classified it Class II
Apr 29, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31399-leading-pharma-recalls-furosemide-80mg-due-to-impurity">Leading Pharma Recalls Furosemide 80mg Due to Impurity (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0486-2026 (March 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0486-2026 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.