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Recall Observatory FDA recall evidence

Drug 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

D-0645-2025

August 28, 2025

Class II

Product summary

Firm
Ascend Laboratories, LLC
Event
Event 97511
Status
Ongoing
Classification
Class II
Quantity
2,256 bottles
Official record key
drug-enforcement:D-0645-2025

Official wording

Reason: Superpotent drug

Code information: Lot #: 24144162, Exp. Date 09/2027

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent