FDA Drugs recall ·
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only… recall
- Recall number
- D-0486-2026
- Date
- (initiated March 20, 2026)
- Company / brand
- Leading Pharma, LLC
3 Oak Rd, Fairfield, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 9384 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Why was it recalled?
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lots# H03125, H03225, H03325, Exp Date: 2027/08
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0486-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.