ClomiPRAMINE Hydrochloride Capsules — Class III drug recall D-1546-2022
Terminated recall by Leading Pharma, LLC, reported 2022-10-05, distributed nationwide. Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
| Recall number | D-1546-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leading Pharma, LLC, Fairfield, NJ, United States |
| Recall initiated | 2022-08-23 |
| Classified | 2022-09-28 |
| Reported by FDA | 2022-10-05 |
| Terminated | 2023-09-28 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| NDC | 69315-0165, 69315-0165-01, 69315-0165-03, 69315-0166, 69315-0166-01, 69315-0166-03, 69315-0166-09, 69315-0167, 69315-0167-01, 69315-0167-03, 69315-0167-09 |
| Lot numbers | B14221 |
| Expiration dates | 2023-02 |
Product
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
Reason for recall
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1546-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.