FDA Drug recall D-0486-2026
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
- FDA Drug
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01 by Leading Pharma, citing CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0486-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-20 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Leading Pharma |
| Distribution | US |
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.
Identifiers
| ndc | 69315-116-01 |
|---|---|
| ndc | 69315-116-10 |
| ndc | 69315-117-01 |
| ndc | 69315-117-10 |
| ndc | 69315-118-01 |
| ndc | 69315-118-05 |
| code_info | Lots# H03125, H03225, H03325, Exp Date: 2027/08 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0486-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.