FDA Drug recall D-0167-2024
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
- FDA Drug
- Class II
- terminated
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class II recall of Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 by Cardinal Healthcare, citing CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0167-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-26 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Healthcare |
| Distribution | US |
Product
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03
Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Identifiers
| ndc | 65162-896-03 |
|---|---|
| ndc | 65162-896-09 |
| ndc | 65162-896-50 |
| ndc | 65162-896-11 |
| ndc | 65162-897-03 |
| ndc | 65162-897-09 |
| ndc | 65162-897-50 |
| ndc | 65162-897-11 |
| ndc | 65162-898-03 |
| ndc | 65162-898-09 |
| ndc | 65162-898-50 |
| ndc | 65162-898-11 |
| ndc | 65162-899-03 |
| ndc | 65162-899-09 |
| ndc | 65162-899-50 |
| ndc | 65162-899-11 |
| ndc | 65162-901-03 |
| ndc | 65162-901-09 |
| ndc | 65162-901-50 |
| ndc | 65162-901-11 |
| ndc | 65162-902-03 |
| ndc | 65162-902-09 |
| ndc | 65162-902-50 |
| ndc | 65162-902-11 |
| code_info | Batch AR202318 |
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-0167-2024%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.