PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: September 24, 2025 Initiated: August 28, 2025 #D-0645-2025

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

Details

Recalling Firm
Ascend Laboratories, LLC
Units Affected
2,256 bottles
Distribution
Nationwide in the USA.
Location
Bedminster, NJ

Frequently Asked Questions

What product 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. Recalled by Ascend Laboratories, LLC. Units affected: 2,256 bottles.
Why was this product recalled?
Superpotent drug
Which agency issued this recall?
This recall was issued by the FDA Drug on September 24, 2025. Severity: Moderate. Recall number: D-0645-2025.