← FDA ENFORCEMENT
D-0645-2025Class II

Ascend Laboratories, LLC

Recalling firm
Ascend Laboratories, LLC
Product type
Drug
Status
Ongoing
Report date
2025-09-24
Distribution
Nationwide in the USA.
Firm state
NJ
Product quantity
2,256 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Superpotent drug

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

Code / lot info

Lot #: 24144162, Exp. Date 09/2027

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.