Aripiprazole Tablet
FDA Recall NDC 67877-430
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Aripiprazole (NDC 67877-430). A significant event, classified as Class II, was initiated on Aug 28, 2025 by Ascend Laboratories, Llc. The reported reason for this action was: "Superpotent drug"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Superpotent drug
Aug 28, 2025
Sep 24, 2025
2,256 bottles
Recall Profile & Regulatory Data
Event ID
97511
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
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
Batch or Lot Expiration Information
Lot# : 24144162, Exp. Date 09/2027
Affected Packages Involved in this Recall
67877-431-03Product
67877-431-01Product
67877-431-05Product
67877-431-33Product
67877-431-38Product
67877-431-32Product
67877-432-03Product
67877-432-01Product
67877-432-05Product
67877-432-33Product
67877-432-38Product
67877-432-32Product
67877-433-03Product
67877-433-01Product
67877-433-05Product
67877-433-33Product
67877-433-38Product
67877-433-32Product
67877-434-03Product
67877-434-01Product
67877-434-05Product
67877-434-33Product
67877-434-38Product
67877-435-03Product
67877-435-01Product
67877-435-05Product
67877-435-33Product
67877-435-38Product
67877-430-03Product
67877-430-01Product
67877-430-05Product
67877-430-33Product
67877-430-38Product
67877-430-32Product
March 2023 Class II Recall: Out of specification (OOS) for Spectroscopic Identification test by IR.
Recall Number
Class II Ongoing
Out of specification (OOS) for Spectroscopic Identification test by IR.
Mar 17, 2023
Apr 26, 2023
135 bottles
Recall Profile & Regulatory Data
Event ID
91918
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
Batch or Lot Expiration Information
Lot# 22143120, Exp. Date: June 2024
Affected Packages Involved in this Recall
67877-431-03Product
67877-431-01Product
67877-431-05Product
67877-431-33Product
67877-431-38Product
67877-431-32Product
67877-432-03Product
67877-432-01Product
67877-432-05Product
67877-432-33Product
67877-432-38Product
67877-432-32Product
67877-433-03Product
67877-433-01Product
67877-433-05Product
67877-433-33Product
67877-433-38Product
67877-433-32Product
67877-434-03Product
67877-434-01Product
67877-434-05Product
67877-434-33Product
67877-434-38Product
67877-435-03Product
67877-435-01Product
67877-435-05Product
67877-435-33Product
67877-435-38Product
67877-430-03Product
67877-430-01Product
67877-430-05Product
67877-430-33Product
67877-430-38Product
67877-430-32Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
