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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Abilify (aripiprazole) Tablets Recalled for Potential Cross-Contamination

Agency Publication Date: April 23, 2024
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Summary

Approximately 108,192 bottles and blister packs of Abilify (aripiprazole) tablets have been voluntarily recalled by Otsuka Pharmaceutical. The recall includes 5 mg, 10 mg, 15 mg, and 30 mg tablets that may have been cross-contaminated with other products during manufacturing at the Second Tokushima Factory in Japan. Consumers are advised to contact their healthcare provider or pharmacist regarding their medication and return any affected products to the place of purchase for a refund.

Risk

The tablets may have been cross-contaminated with other pharmaceutical products during the production process. This poses a risk that patients could be exposed to unintended substances, which could lead to adverse health effects or reduce the efficacy of their treatment.

What You Should Do

  1. This recall affects Abilify (aripiprazole) tablets in 5 mg, 10 mg, 15 mg, and 30 mg strengths packaged in 30-count bottles or 7-count blister packs.
  2. Check the lot number and expiration date printed on your medication packaging. Affected codes include lots AKS00623A, AKS00322A, ALS00422A, ALS00523A, 1K77YUD1H1A, AMS00223A, APS00423A, and APS00222A. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Abilify (aripiprazole) 5 mg Tablets
Variants: 5 mg, 30 count bottle
Lot Numbers:
AKS00623A (Exp 01/31/2026)
AKS00322A (Exp 02/28/2025)
NDC:
59148-007-13

RX only

Product: Abilify (aripiprazole) 10 mg Tablets
Variants: 10 mg, 30 count bottle, 7 count blister pack
Lot Numbers:
ALS00422A (Exp 04/30/2025)
ALS00523A (Exp 11/30/2025)
1K77YUD1H1A (Exp 11/30/2024)
NDC:
59148-008-13
59148-008-95

RX only

Product: Abilify (aripiprazole) 15 mg Tablets
Variants: 15 mg, 30 count bottle
Lot Numbers:
AMS00223A (Exp 07/31/2025)
NDC:
59148-009-13

RX only

Product: Abilify (aripiprazole) 30 mg Tablets
Variants: 30 mg, 30 count bottle
Lot Numbers:
APS00423A (Exp 07/31/2025)
APS00222A (Exp 11/30/2024)
NDC:
59148-011-13

RX only

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94382
Status: Active
Manufacturer: Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Sold By: Otsuka America Pharmaceutical, Inc.; Pharmacies
Manufactured In: Japan
Units Affected: 108,192/30 count bottles or 7 count blister packs
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.