← FDA ENFORCEMENT
D-0469-2024Class 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
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
2026-07-22Class IArgon Medical Devices, Inc2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC2026-07-22Class IIOlympus Corporation of the Americas
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.