Home Recalls D-0645-2025
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.
Class II · Moderate risk Ongoing May 27, 2026
Reason Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Class III · Low risk Ongoing Apr 9, 2024
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing Apr 9, 2024
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing Apr 9, 2024
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing Apr 9, 2024
Reason Cross Contamination with Other Products