FDA DrugsClass II
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: L...
Published: April 29, 2026Recall ID: D-0486-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Product Description & Identification
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Additional Source Details
| Field | Value |
|---|---|
| City | Fairfield |
| State | NJ |
| Openfda › Nui › 1 | N0000175366 |
| Openfda › Nui › 2 | N0000175590 |
| Openfda › Unii | 7LXU5N7ZO5 |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 197732 |
| Openfda › Rxcui › 2 | 310429 |
| Openfda › Rxcui › 3 | 313988 |
| Openfda › Spl id | 445bfa17-a52c-4492-9dbc-94218b30c1db |
| Openfda › Brand name | FUROSEMIDE |
| Openfda › Spl set id | b5c6fcf4-fd37-4fee-8dac-1a3273d95ffe |
| Openfda › Package ndc › 1 | 69315-116-01 |
| Openfda › Package ndc › 2 | 69315-116-10 |
| Openfda › Package ndc › 3 | 69315-117-01 |
| Openfda › Package ndc › 4 | 69315-117-10 |
| Openfda › Package ndc › 5 | 69315-118-01 |
| Openfda › Package ndc › 6 | 69315-118-05 |
| Openfda › Product ndc › 1 | 69315-116 |
| Openfda › Product ndc › 2 | 69315-117 |
| Openfda › Product ndc › 3 | 69315-118 |
| Openfda › Generic name | FUROSEMIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class pe | Increased Diuresis at Loop of Henle [PE] |
| Openfda › Substance name | FUROSEMIDE |
| Openfda › Pharm class epc | Loop Diuretic [EPC] |
| Openfda › Manufacturer name | Leading Pharma, LLC |
| Openfda › Application number | ANDA077293 |
| Openfda › Is original packager | true |
| Event id | 98628 |
| Address 1 | 3 Oak Rd |
| Address 2 | N/A |
| Code info | Lots# H03125, H03225, H03325, Exp Date: 2027/08 |
| Postal code | 07004-2903 |
| Report date | 20260429 |
| Product type | Drugs |
| Product quantity | 9384 bottles |
| Reason for recall | CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260320 |
| Initial firm notification | Letter |
| Center classification date | 20260421 |
Overview
- Recalling FirmLeading Pharma, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.