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.
What this means for you
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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- ModeratePrescription Drug Recall: ABILIFY Tablets Due to Cross Contamination
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- ModerateBristol Myers Squibb Recalls Abilify Tablets Due to Manufacturing Error
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