Class IIOngoing

Aripiprazole Tablets recall

FDA recall D-0645-2025 · initiated Aug 28, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Superpotent drug

Details

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
Recalling company: Ascend Laboratories, Ltd
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA.
Initiated: Aug 28, 2025
FDA report date: Sep 24, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0645-2025 ↗

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