Fairfield, NJ, United States
Leading Pharma, LLC recalls
2 recalls recorded since 2018, most recently on 20 March 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 20 March 2026
- Reason
- CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class III Drugs
- Recall started
- 23 August 2022
- Terminated
- 28 September 2023
- Reason
- Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1546-2022
- ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.