Quick Facts at a Glance
- Recall Date
- March 20, 2026
- Hazard Level
- HIGH
- Brands
- FUROSEMIDE, Leading Pharma, LLC
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- FUROSEMIDE, Leading Pharma, LLC
- Model numbers
- Lots# H03125, H03225, H03325, Exp Date: 2027/08
- UPC codes
- 69315-116, 69315-117, 69315-118, 69315-116-01, 69315-116-10, 69315-117-01, 69315-117-10, 69315-118-01 +1 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 20, 2026
Reported by FDA DRUG
April 29, 2026
RecallRadar source check
May 6, 2026
Consumer action
Use the official remedy and keep documentation.
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.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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