Prescription medication Abilify recalled for cross contamination with other products
Otsuka America Pharmaceutical is recalling certain lots of Abilify (aripiprazole) 5 mg tablets distributed nationwide due to cross contamination with other products. This is classified as a Class III recall.
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, injuries, or deaths. Per the severity rubric, Class III recalls are typically scored 1 or 2. Cross-contamination without documented harm meets the criteria for a Moderate (score 2) classification.
Plain-English summary
Otsuka America Pharmaceutical, Inc. is recalling certain lots of Abilify (aripiprazole) 5 mg tablets. The affected products are packaged in 30-count bottles or 7-count blister packs and were distributed nationwide. The recall affects two specific lot numbers: AKS00623A (expiring 01/31/2026) and AKS00322A (expiring 02/28/2025), representing approximately 108,192 units.
The manufacturer initiated this recall due to cross contamination with other products that occurred during manufacturing. This is classified as a Class III recall by the FDA.
If you have a prescription for Abilify from the affected lots, contact your pharmacist or healthcare provider for guidance.
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 (4)
- Lot # AKS00623A
- Exp 01/31/2026
- AKS00322A
- Exp 02/28/2025
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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