US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Aug 28, 2025 (12 months ago)

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Superpotent drug

What was recalled

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

Recalling firm
Ascend Laboratories, LLC
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0645-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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