Furosemide Recall: Leading Pharma 80 mg 100-Tab Rx
Announced 2026-04-29 · FDA
Leading Pharma, LLC Furosemide Tablets, 80 mg, 100 tablets, Rx only, are recalled due to CGMP deviations and presence of N-nitroso-Furosemide above the recommended intake limit. About 9,384 bottles distributed nationwide are affected. The affected lots are H03125, H03225, and H03325 with expiration August 2027.
| Brand | Leading Pharma, LLC |
|---|---|
| Product | 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. |
| Severity | moderate |
| Units affected | 9384 |
| Distribution | US Nationwide. |
| Agency | FDA |
| Recall / campaign no. | Lots# H03125, H03225, H03325, Exp Date: 2027/08 |
WHAT YOU SHOULD DO
- Do not use recalled Furosemide tablets from the affected lots.
- Check your bottle's lot number and expiration date; if they match H03125, H03225, or H03325 and 2027/08, stop using the product and follow return instructions from the manufacturer or your pharmacy.
- Consult your healthcare provider if you have taken the product or if you have any adverse symptoms.
- Visit the FDA recall page or contact Leading Pharma for more information and instructions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.