FDA Drug recall D-0114-2021
Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9,…
- FDA Drug
- Class II
- terminated
- Published 2020-12-09
On 2020-12-09 the FDA classified a Class II recall of Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9,… by The Harvard Drug Group, citing failed Dissolution Specifications: Out of specification for dissolution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0114-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-18 |
| Published | 2020-12-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
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
Failed Dissolution Specifications: Out of specification for dissolution.
Identifiers
| code_info | Lots: T02520, T02637, exp 02/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2025-10-29 · The Harvard Drug Group
All The Harvard Drug Group recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0114-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.