FDA Drug recall D-1546-2022
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield,…
- FDA Drug
- Class III
- terminated
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class III recall of ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield,… by Leading Pharma, citing superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1546-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-08-23 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Leading Pharma |
| Distribution | US |
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
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Identifiers
| ndc | 69315-167-03 |
|---|---|
| ndc | 69315-167-01 |
| ndc | 69315-167-09 |
| ndc | 69315-166-03 |
| ndc | 69315-166-01 |
| ndc | 69315-166-09 |
| ndc | 69315-165-03 |
| ndc | 69315-165-01 |
| code_info | Lot#: B14221, Exp. Date 02/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1546-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.