Prescription Drug Recall: ABILIFY Tablets Due to Cross Contamination
ABILIFY (aripiprazole) 15 mg tablets from lot AMS00223A are being recalled due to cross contamination with other products. The recall affects packages distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. Per the severity rubric, FDA Class III recalls are typically rated 1 or 2. The cross-contamination is characterized as low-risk contamination without evidence of actual harm, supporting a Moderate (score 2) rating.
Plain-English summary
Otsuka Pharmaceutical Co., Ltd. is recalling ABILIFY (aripiprazole) 15 mg tablets in 30-count bottles due to cross contamination with other products. The affected lot is AMS00223A with an expiration date of July 31, 2025.
This recall applies to ABILIFY 15 mg tablets distributed nationwide in the United States. Patients who have received this medication from the affected lot should contact their healthcare provider or pharmacist for guidance.
Further information about this recall and manufacturer contact details are available through the FDA's drug safety and availability website.
The recalled product
- Product
- ABILIFY (ARIPIPRAZOLE)
- Brand
- ABILIFY
- Category
- Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # AMS00223A
- Exp 07/31/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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