Aripiprazole Tablets — Class III drug recall D-0471-2017
Terminated recall by Apotex Inc., reported 2017-02-15, distributed nationwide. Superpotent Drug: Product may not meet specifications throughout shelf life.
| Recall number | D-0471-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., Toronto, N/A, Canada |
| Recall initiated | 2016-12-19 |
| Classified | 2017-02-09 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2022-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 67,946 bottles |
| Reason classes | potency |
| NDC | 60505-3075-03 |
| Lot numbers | 04/17, MJ7746 |
Product
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
Reason for recall
Superpotent Drug: Product may not meet specifications throughout shelf life.
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-0471-2017. 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.