Abilify Tablet
FDA Recall NDC 59148-009
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Abilify (NDC 59148-009). A significant event, classified as Class III, was initiated on Apr 09, 2024 by Otsuka America Pharmaceutical, Inc.. The reported reason for this action was: "Cross Contamination with Other Products"
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 III Ongoing
Cross Contamination with Other Products
Apr 09, 2024
May 01, 2024
108,192/30 count bottles or 7 count blister packs
Recall Profile & Regulatory Data
Event ID
94382
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Product Description
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
Batch or Lot Expiration Information
Lot# AKS00623A, Exp 01/31/2026; AKS00322A, Exp 02/28/2025
Affected Packages Involved in this Recall
59148-006-13Product
59148-006-92Product
59148-007-13Product
59148-007-35Product
59148-007-94Product
59148-008-13Product
59148-008-35Product
59148-008-95Product
59148-009-13Product
59148-009-35Product
59148-009-95Product
59148-010-13Product
59148-010-35Product
59148-011-13Product
59148-011-35Product
Class III Ongoing
Cross Contamination with Other Products
Apr 09, 2024
May 01, 2024
N/A
Recall Profile & Regulatory Data
Event ID
94382
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Product Description
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
Batch or Lot Expiration Information
Lot# AMS00223A, Exp 07/31/2025
Affected Packages Involved in this Recall
59148-006-13Product
59148-006-92Product
59148-007-13Product
59148-007-35Product
59148-007-94Product
59148-008-13Product
59148-008-35Product
59148-008-95Product
59148-009-13Product
59148-009-35Product
59148-009-95Product
59148-010-13Product
59148-010-35Product
59148-011-13Product
59148-011-35Product
Class III Ongoing
Cross Contamination with Other Products
Apr 09, 2024
May 01, 2024
N/A
Recall Profile & Regulatory Data
Event ID
94382
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Product Description
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.
Batch or Lot Expiration Information
Lot# : a) ALS00422A, Exp 04/30/2025; ALS00523A, Exp 11/30/2025; b) 1K77YUD1H1A, Exp 11/30/2024
Affected Packages Involved in this Recall
59148-006-13Product
59148-006-92Product
59148-007-13Product
59148-007-35Product
59148-007-94Product
59148-008-13Product
59148-008-35Product
59148-008-95Product
59148-009-13Product
59148-009-35Product
59148-009-95Product
59148-010-13Product
59148-010-35Product
59148-011-13Product
59148-011-35Product
Class III Ongoing
Cross Contamination with Other Products
Apr 09, 2024
May 01, 2024
N/A
Recall Profile & Regulatory Data
Event ID
94382
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Product Description
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13
Batch or Lot Expiration Information
Lot# APS00423A, Exp 07/31/2025; APS00222A, Exp 11/30/2024
Affected Packages Involved in this Recall
59148-006-13Product
59148-006-92Product
59148-007-13Product
59148-007-35Product
59148-007-94Product
59148-008-13Product
59148-008-35Product
59148-008-95Product
59148-009-13Product
59148-009-35Product
59148-009-95Product
59148-010-13Product
59148-010-35Product
59148-011-13Product
59148-011-35Product
Class II Terminated
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
Nov 02, 2012
Mar 13, 2013
21 blister packs
Recall Profile & Regulatory Data
Event ID
63706
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Bristol Myers Squibb Manufacturing Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
LA, TN, CA
Termination Date
May 02, 2013
Product Description
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
Batch or Lot Expiration Information
Lot# 2E69023A, Exp. FEB 28 2015
Affected Packages Involved in this Recall
59148-006-13Product
59148-006-92Product
59148-007-13Product
59148-007-35Product
59148-007-94Product
59148-008-13Product
59148-008-35Product
59148-008-95Product
59148-009-13Product
59148-009-35Product
59148-009-95Product
59148-010-13Product
59148-010-35Product
59148-011-13Product
59148-011-35Product
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.
