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.
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: 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
- Manufacturer
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Category
- Drug — Antipsychotic
- Hazard
- cross-contamination
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.
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- ModeratePrescription Drug Recall: ABILIFY Tablets Due to Cross Contamination
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FDA (Drugs) · 2024-05-01
- ModeratePrescription antipsychotic tablets Abilify recalled for cross-contamination with other products
FDA (Drugs) · 2024-05-01
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