Class II · ModerateActive recall
Furosemide
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLots# H03125, H03225, H03325, Exp Date: 2027/08
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byLeading Pharma, LLC, Fairfield, NJ 07004
| Brand name | FUROSEMIDE |
| Generic name | FUROSEMIDE |
| Active ingredient(s) | FUROSEMIDE |
| Distributed by / for | Leading Pharma, LLC |
| NDC | 69315-118-01 |
Show the full FDA record
| Full product label | 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 |
| Distribution | US Nationwide. |
| Quantity | 9384 bottles |
| Recall initiated | 2026-03-20 |
| Report date | 2026-04-29 |
| Recall completed | — |
| Recall number | D-0486-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Fairfield NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.