Recall: D-0645-2025

Class II - Potentially Harmful

Class IIClassification

2025-08-28Initiated

OngoingStatus

Ascend Laboratories, LLCFirm

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

Distribution

Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.