Furosemide Tablets recall (Leading Pharma, LLC)
DrugClass IIOngoing
Summary: Leading Pharma, LLC is recalling Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01. Reason: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
What is being recalled
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Why
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lots# H03125, H03225, H03325, Exp Date: 2027/08
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0486-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 20, 2026 |
| Reported | April 29, 2026 |
| Company | Leading Pharma, LLC |
| Company location | Fairfield, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 9384 bottles |
More recalls from Leading Pharma, LLC · all drug recalls · recalls from March 2026