Aripiprazole Tablets — Class II drug recall D-0368-2023
Terminated recall by Accord Healthcare, Inc., reported 2023-03-08, distributed in PR. CGMP Deviations: recalling drug products following an FDA inspection.
| Recall number | D-0368-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Healthcare, Inc., Durham, NC, United States |
| Recall initiated | 2023-02-07 |
| Classified | 2023-03-02 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2024-04-22 |
| Distributed | PR |
| Countries outside the US | CA |
| Quantity | 312,864 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00316729281010, 00316729281102 |
| NDC | 16729-0278, 16729-0278-01, 16729-0278-10, 16729-0278-16, 16729-0278-46, 16729-0279, 16729-0279-01, 16729-0279-10, 16729-0279-16, 16729-0279-46, 16729-0280, 16729-0280-01, 16729-0280-10, 16729-0280-16, 16729-0280-46, 16729-0281, 16729-0281-01, 16729-0281-10, 16729-0281-16, 16729-0281-46, 16729-0282, 16729-0282-01, 16729-0282-10, 16729-0282-16, 16729-0282-46 and 5 more |
| Expiration dates | 2023-08-31, 2024-01-31, 2024-04-30, 2024-07-31, 2024-10-31, 2025-05-31, 2025-07-31 |
Product
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 16729-281-01, UPC 3 16729 28101 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
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-0368-2023. 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.