Drug Enforcement D-0645-2025

Superpotent drug

Status

Ongoing

Classification

Class II

Report Date

September 24, 2025

Termination Date

Product Information

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
Product quantity
2,256 bottles
Reason for recall
Superpotent drug
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA.

Location & Firm

Recalling firm
Ascend Laboratories, LLC
Address
135 Us Highway 202 206 Ste 15, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0645-2025
Event ID
97511
Recall initiation date
August 28, 2025
Center classification date
September 12, 2025
Code info
Lot #: 24144162, Exp. Date 09/2027
More code info