← FDA ENFORCEMENT
D-0466-2024Class III

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

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
108,192/30 count bottles or 7 count blister packs
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Cross Contamination with Other Products

Product description

Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13

Code / lot info

Lot # AKS00623A, Exp 01/31/2026; AKS00322A, Exp 02/28/2025

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IArgon Medical Devices, Inc2026-07-22Class IIOlympus Corporation of the Americas2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. 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.