Aripiprazole Tablets — Class II drug recall D-1285-2022
Terminated recall by Apotex Corp., reported 2022-07-27, distributed nationwide. Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
| Recall number | D-1285-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2022-07-07 |
| Classified | 2022-07-21 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2025-09-22 |
| Distributed | Nationwide (US) |
| Quantity | 2,010 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00360505267637, 00360505267682 |
| NDC | 60505-2676-03, 60505-2676-08 |
| Expiration dates | 2023-04 |
Product
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Reason for recall
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
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-1285-2022. 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.