Aripiprazole Tablet
FDA Recall NDC 62332-101
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Aripiprazole (NDC 62332-101). A significant event, classified as Class II, was initiated on Jun 10, 2020 by Alembic Pharmaceuticals Inc.. The reported reason for this action was: "Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Jun 10, 2020
Jul 01, 2020
19,153 bottles
Recall Profile & Regulatory Data
Event ID
85835
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Alembic Pharmaceuticals Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Jan 19, 2022
Product Description
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.
Batch or Lot Expiration Information
Lot# Lot: 1905003298 Exp. 01/31/2021
Affected Packages Involved in this Recall
62332-097-30Product
62332-097-71Product
62332-097-91Product
62332-097-31Product
62332-097-10Product
62332-098-30Product
62332-098-31Product
62332-098-91Product
62332-098-10Product
62332-098-71Product
62332-099-30Product
62332-099-31Product
62332-099-71Product
62332-099-91Product
62332-099-10Product
62332-100-30Product
62332-100-31Product
62332-100-71Product
62332-100-91Product
62332-100-10Product
62332-101-30Product
62332-101-31Product
62332-101-71Product
62332-101-91Product
62332-101-10Product
62332-102-30Product
62332-102-31Product
62332-102-71Product
62332-102-91Product
62332-102-10Product
1905003298Product
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.
