FDA Recall D-0467-2024
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), 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
Recall record
- Recall number
D-0467-2024- 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.