Aripiprazole Tablets — Class II drug recall D-0106-2021
Terminated recall by Apotex Corp., reported 2020-11-25, distributed nationwide. Failed Dissolution Specifications: Out of specification for dissolution.
| Recall number | D-0106-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2020-11-11 |
| Classified | 2020-11-24 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2021-08-11 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 60505-2675-03, 60505-2675-08 |
| Expiration dates | 2021-02 |
Product
Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Reason for recall
Failed Dissolution Specifications: Out of specification for dissolution.
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-0106-2021. 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.