Prescription antipsychotic tablets Abilify recalled for cross-contamination with other products
Certain lots of Abilify (aripiprazole) 10 mg tablets are being recalled due to cross-contamination with other products. Affected products were distributed nationwide.
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 a Class III recall with no reported illnesses or injuries. Cross-contamination represents a low-risk theoretical hazard, consistent with the rubric classification of Class III recalls as typically scoring 1 or 2.
Plain-English summary
The FDA has issued a Class III recall for certain lots of Abilify (aripiprazole) 10 mg tablets manufactured by Otsuka Pharmaceutical Co., Ltd. The recall was initiated due to cross-contamination with other products.
Affected lots include: a) 30-count bottles with lot ALS00422A (expiration 04/30/2025) and lot ALS00523A (expiration 11/30/2025); b) 7-count blister packs with lot 1K77YUD1H1A (expiration 11/30/2024). These products were distributed nationwide across the United States.
ABILIFY is a prescription medication used in the treatment of psychiatric conditions. The product is marketed by Otsuka America Pharmaceutical, Inc.
Patients currently taking affected lots should consult their healthcare provider or pharmacist. Do not stop taking the medication without speaking to a healthcare professional, as abrupt discontinuation could have health consequences.
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 (6)
- Lot #: a) ALS00422A
- Exp 04/30/2025
- ALS00523A
- Exp 11/30/2025
- b) 1K77YUD1H1A
- Exp 11/30/2024
Distribution
Distributed nationwide across the United States.
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FDA (Drugs) · 2024-05-01
- ModeratePrescription drug Abilify 30mg tablets recalled for cross-product contamination
FDA (Drugs) · 2024-05-01
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