← FDA ENFORCEMENT
D-0467-2024Class 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), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.

Code / lot info

Lot #: a) ALS00422A, Exp 04/30/2025; ALS00523A, Exp 11/30/2025; b) 1K77YUD1H1A, Exp 11/30/2024

Other recalls SPEQ maps to Environmental Monitoring
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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.