Abilify — Class III drug recall D-0466-2024
Ongoing recall by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd., reported 2024-05-01, distributed nationwide. Cross Contamination with Other Products
| Recall number | D-0466-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd., Tokushima, N/A, Japan |
| Recall initiated | 2024-04-09 |
| Classified | 2024-04-23 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 108,192 |
| NDC | 59148-0006, 59148-0006-13, 59148-0006-92, 59148-0007, 59148-0007-13, 59148-0007-35, 59148-0007-94, 59148-0008, 59148-0008-13, 59148-0008-35, 59148-0008-95, 59148-0009, 59148-0009-13, 59148-0009-35, 59148-0009-95, 59148-0010, 59148-0010-13, 59148-0010-35, 59148-0011, 59148-0011-13, 59148-0011-35 |
| Lot numbers | AKS00322A, AKS00623A |
| Expiration dates | 2025-02-28, 2026-01-31 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0466-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.