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 |
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.
How to identify the recalled item
| Lot / date codes | Lots# H03125, H03225, H03325, Exp Date: 2027/08 |
|---|---|
| Lot / date codes | Lots# H03125, H03225, H03325, Exp Date: 2027/08 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.