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- FDA Recall: Abilify
FDA Recall Abilify
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Abilify with NDC 59148-008 was initiated on 04-09-2024 as a Class III recall due to cross contamination with other products The latest recall number for this product is D-0468-2024 and the recall is currently ongoing .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0468-2024 | 04-09-2024 | 05-01-2024 | Class III | Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13 | Ongoing | |
| D-0467-2024 | 04-09-2024 | 05-01-2024 | Class III | 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. | Ongoing | |
| D-0466-2024 | 04-09-2024 | 05-01-2024 | Class III | 108,192/30 count bottles or 7 count blister packs | Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13 | Ongoing |
| D-0469-2024 | 04-09-2024 | 05-01-2024 | Class III | Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13 | Ongoing | |
| D-181-2013 | 11-02-2012 | 03-13-2013 | Class II | 21 blister packs | ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
Recall Enforcement Report D-0468-2024
- Event ID
- 94382 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0468-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- USA nationwide. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
- Reason For Recall
- Cross Contamination with Other Products What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 05-01-2024
- Recall Initiation Date
- 04-09-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Code Info
- Lot # AMS00223A, Exp 07/31/2025 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35; 59148-013-15; 59148-640-23; 59148-641-23; 59148-016-65
- Status
- Ongoing
Recall Enforcement Report D-0467-2024
- Event ID
- 94382 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0467-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- USA nationwide. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- Cross Contamination with Other Products What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 05-01-2024
- Recall Initiation Date
- 04-09-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Code Info
- Lot #: a) ALS00422A, Exp 04/30/2025; ALS00523A, Exp 11/30/2025; b) 1K77YUD1H1A, Exp 11/30/2024 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35; 59148-013-15; 59148-640-23; 59148-641-23; 59148-016-65
- Status
- Ongoing
Recall Enforcement Report D-0466-2024
- Event ID
- 94382 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0466-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- USA nationwide. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
- Reason For Recall
- Cross Contamination with Other Products What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 108,192/30 count bottles or 7 count blister packs Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 05-01-2024
- Recall Initiation Date
- 04-09-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Code Info
- Lot # AKS00623A, Exp 01/31/2026; AKS00322A, Exp 02/28/2025 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35; 59148-013-15; 59148-640-23; 59148-641-23; 59148-016-65
- Status
- Ongoing
Recall Enforcement Report D-0469-2024
- Event ID
- 94382 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0469-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- USA nationwide. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13
- Reason For Recall
- Cross Contamination with Other Products What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 05-01-2024
- Recall Initiation Date
- 04-09-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Code Info
- Lot # APS00423A, Exp 07/31/2025; APS00222A, Exp 11/30/2024 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35; 59148-013-15; 59148-640-23; 59148-641-23; 59148-016-65
- Status
- Ongoing
Recall Enforcement Report D-181-2013
- Event ID
- 63706 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-181-2013 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- LA, TN, CA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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
- Reason For Recall
- 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. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 21 blister packs Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 03-13-2013
- Recall Initiation Date
- 11-02-2012 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-02-2013 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Bristol Myers Squibb Manufacturing Company
- Code Info
- 2E69023A, Exp. FEB 28 2015 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35; 59148-013-15; 59148-640-23; 59148-641-23; 59148-016-65
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.