D-0645-2025 Class II Ongoing
FDA drug recall D-0645-2025 was initiated by Ascend Laboratories, LLC on August 28, 2025 and is designated Class II. Reason for recall: Superpotent drug The recall status is ongoing. Affected quantity: 2,256 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 24, 2025
- Initiation Date
- August 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,256 bottles
Product Description
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 for Recall
Superpotent drug
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: 24144162, Exp. Date 09/2027