CLASS II ONGOING Drug recall · Reported 29 Apr 2026 · FDA Enforcement Report
Furosemide Tablets, USP, 80 mg recalled by Leading Pharma
Leading Pharma is recalling Furosemide Tablets, USP, 80 mg, distributed nationwide in the US. The recall was initiated on 20 Mar 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0486-2026
- FDA event ID
- 98628
- Recalling firm
- Leading Pharma, Fairfield, NJ
- Brand
- Furosemide
- Manufacturer
- Leading Pharma, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Mar 2026
- FDA classified
- 21 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
Timeline
| 20 Mar 2026 | Recall initiated by company | |
| 21 Apr 2026 | Classified by FDA | +32 days |
| 29 Apr 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Which lots are affected?
Lots# H03125, H03225, H03325, Exp Date: 2027/08
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Leading Pharma
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | ClomiPRAMINE Hydrochloride Capsules, USP 25mg recalled by Leading PharmaClomipramine Hydrochloride | Leading Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Tablets, USP CIV, 0.5 mg recalled by Leading PharmaLorazepam | Leading Pharma | Other | Nationwide |
Other Furosemide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Furosemide Tablets, USP 40 mg recalled by Graviti PharmaceuticalsFurosemide | Graviti Pharmaceuticals Private | Other | Nationwide |
| Drug | CLASS II | Furosemide Tablets USP, 20 mg recalled by Roxane LaboratoriesFurosemide | Roxane Laboratories | Other | Nationwide |
| Drug | CLASS II | Furosemide 20 mg/mL svn Sol, Rx recalled by Western Drug | Western Drug | Sterility | Nationwide |
| Drug | CLASS III | Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Furosemide Tablets USP, 20 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |