Why it was recalled
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Product description
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Lot numbers, UPCs & expiration codes
Lots# H03125, H03225, H03325, Exp Date: 2027/08
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0486-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 20, 2026
- FDA report date
- Apr 29, 2026
- Quantity
- 9384 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Leading Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0486-2026, exactly as published.
Show all FDA fields
- City
- Fairfield
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98628
- Address
- 3 Oak Rd
- Code information
- Lots# H03125, H03225, H03325, Exp Date: 2027/08
- Postal code
- 07004-2903
- Report date
- Apr 29, 2026
- Product type
- Drugs
- Recall number
- D-0486-2026
- Classification
- Class II
- Recalling firm
- Leading Pharma, LLC
- Product quantity
- 9384 bottles
- Reason for recall
- CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Mar 20, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 21, 2026