Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories ...
FDA Recall #D-0645-2025 — Class II — August 28, 2025
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
Recalling Firm
Ascend Laboratories, LLC — Bedminster, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,256 bottles
Distribution
Nationwide in the USA.
Code Information
Lot #: 24144162, Exp. Date 09/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated