Aripiprazole Tablets — Class II drug recall D-0114-2021
Terminated recall by The Harvard Drug Group, reported 2020-12-09, distributed nationwide. Failed Dissolution Specifications: Out of specification for dissolution.
| Recall number | D-0114-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2020-11-18 |
| Classified | 2020-12-01 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2023-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 841 cartons |
| Reason classes | specification failure |
| NDC | 00904-6512-04 |
| Lot numbers | T02520, T02637 |
| Expiration dates | 2021-02 |
Product
Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
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-0114-2021. 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.