FDA Recall D-0468-2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Tokushima, N/A
Class III Ongoing 765 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
Product
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
Recall record
- Recall number
D-0468-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA nationwide.
- Recall initiated
- 2024-04-09
- Classified by FDA Center
- 2024-04-23
- FDA published
- 2024-05-01
- Recalling firm
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Firm location
- Tokushima, N/A, Japan
Drug identification
- Brand name(s)
- ABILIFY
- Generic name(s)
- ARIPIPRAZOLE
- Manufacturer(s)
- Otsuka America Pharmaceutical, Inc.
- NDC(s)
59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.