FDA recall D-0645-2025

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 for recall

Superpotent drug

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2025-08-28

Report date

2025-09-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedminster, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0645-2025