Prescription drug Abilify 30mg tablets recalled for cross-product contamination
Abilify (aripiprazole) 30mg tablets are being recalled due to cross-contamination with other products. The affected lots were distributed nationwide in the United States.
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: FDA classified this as a Class III recall, which represents the lowest risk category for drug recalls. No illnesses or injuries are reported in the source documentation. The hazard involves theoretical cross-contamination with unspecified products, consistent with a precautionary, low-risk recall.
Plain-English summary
Otsuka America Pharmaceutical, Inc. is recalling Abilify (aripiprazole) 30mg tablets due to cross-contamination with other products. The recalled product consists of 30-count bottles with NDC 59148-011-13. Two specific lot numbers are affected: Lot # APS00423A (expiration date 07/31/2025) and Lot # APS00222A (expiration date 11/30/2024).
The FDA classified this as a Class III recall.
The affected product was distributed nationwide throughout the United States.
Consumers who have affected lots should consult their healthcare provider regarding their prescription.
The recalled product
- Product
- ABILIFY (ARIPIPRAZOLE)
- Brand
- ABILIFY
- Category
- Drug — Antipsychotic
- 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 # APS00423A
- Exp 07/31/2025
- APS00222A
- Exp 11/30/2024
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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