Recalls / Class III
Class IIID-0468-2024
Product
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
- Brand name
- Abilify
- Generic name
- Aripiprazole
- Active ingredient
- Aripiprazole
- Route
- Oral
- NDCs
- 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011
- FDA application
- NDA021436
- Affected lot / code info
- Lot # AMS00223A, Exp 07/31/2025
Why it was recalled
Cross Contamination with Other Products
Recalling firm
- Firm
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Manufacturer
- Otsuka America Pharmaceutical, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 224-18, Kawauchi-Cho, Tokushima, N/A N/A, Japan
Distribution
- Quantity
- N/A
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-04-09
- FDA classified
- 2024-04-23
- Posted by FDA
- 2024-05-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0468-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.