Furosemide Tablets — Class II drug recall D-0486-2026
Ongoing recall by Leading Pharma, LLC, reported 2026-04-29, distributed nationwide. CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
| Recall number | D-0486-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leading Pharma, LLC, Fairfield, NJ, United States |
| Recall initiated | 2026-03-20 |
| Classified | 2026-04-21 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 9,384 bottles |
| Reason classes | cgmp |
| NDC | 69315-0116, 69315-0116-01, 69315-0116-10, 69315-0117, 69315-0117-01, 69315-0117-10, 69315-0118, 69315-0118-01, 69315-0118-05 |
| Lot numbers | 2027/08, H03125, H03225, H03325 |
Product
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Reason for recall
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0486-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.