FDA Drug recall D-0645-2025
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA
- FDA Drug
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA by Ascend Laboratories, citing superpotent drug.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0645-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-28 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
Product
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03
Reason
Superpotent drug
Identifiers
| ndc | 67877-431-03 |
|---|---|
| ndc | 67877-431-01 |
| ndc | 67877-431-05 |
| ndc | 67877-431-33 |
| ndc | 67877-431-38 |
| ndc | 67877-431-32 |
| ndc | 67877-432-03 |
| ndc | 67877-432-01 |
| ndc | 67877-432-05 |
| ndc | 67877-432-33 |
| ndc | 67877-432-38 |
| ndc | 67877-432-32 |
| ndc | 67877-433-03 |
| ndc | 67877-433-01 |
| ndc | 67877-433-05 |
| ndc | 67877-433-33 |
| ndc | 67877-433-38 |
| ndc | 67877-433-32 |
| ndc | 67877-434-03 |
| ndc | 67877-434-01 |
| ndc | 67877-434-05 |
| ndc | 67877-434-33 |
| ndc | 67877-434-38 |
| ndc | 67877-435-03 |
| ndc | 67877-435-01 |
| ndc | 67877-435-05 |
| ndc | 67877-435-33 |
| ndc | 67877-435-38 |
| ndc | 67877-430-03 |
| ndc | 67877-430-01 |
| ndc | 67877-430-05 |
| ndc | 67877-430-33 |
| ndc | 67877-430-38 |
| ndc | 67877-430-32 |
| code_info | Lot #: 24144162, Exp. Date 09/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0645-2025%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.