Drug recall
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA…
FDA recall event 97511 · Class II · Ascend Laboratories, LLC
Key facts
| Event ID | 97511 |
|---|---|
| Recall numbers | D-0645-2025 |
| Recalling firm | Ascend Laboratories, LLC |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Superpotent drug |
| Initiation date | Aug 28, 2025 |
| Report date | Sep 24, 2025 |
| City | Bedminster |
| State | NJ |
| Country | United States |
| FEI number | 3004459274 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: