← FDA ENFORCEMENT
D-0469-2024Class III

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Product type
Drug
Status
Ongoing
Report date
2024-05-01
Distribution
USA nationwide.
Firm state
N/A
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Cross Contamination with Other Products

Product description

Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13

Code / lot info

Lot # APS00423A, Exp 07/31/2025; APS00222A, Exp 11/30/2024

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →