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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Apotex Aripiprazole Tablets Recalled for Failed Dissolution Testing

Agency Publication Date: July 21, 2022
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Summary

Apotex Corp. is recalling approximately 2,010 bottles of Aripiprazole Tablets, USP 20 mg, which is a generic version of the medication Abilify. This recall was initiated after a stability test at the 12-month mark showed that the tablets failed to meet dissolution specifications. No incidents or injuries have been reported to date in connection with this recall.

Risk

If a tablet fails to dissolve properly, the medication may not be fully absorbed by the body. This can lead to a reduction in the drug's effectiveness, potentially causing a relapse or worsening of psychiatric symptoms in patients relying on the medication.

What You Should Do

  1. The recalled products are Apotex brand Aripiprazole Tablets, USP 20 mg, sold in 30-count bottles (UPC 360505267637) and 1,000-count bottles (UPC 360505267682).
  2. Check your medication packaging for lot numbers TD9591 (Exp. 04/2023) or TD9592 (Exp. 04/2023).
  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 Apotex Corp. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

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: Aripiprazole Tablets, USP 20 mgby Apotex
Variants: 20 mg, Tablet
UPC Codes:
360505267682
360505267637
Lot Numbers:
TD9591 (Exp. 04/2023)
TD9592 (Exp. 04/2023)
NDC:
60505-2676-8
60505-2676-3

Recall #: D-1285-2022. Quantities distributed in 1,000-count and 30-count bottles.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90569
Status: Resolved
Manufacturer: Apotex Corp.
Sold By: Pharmacies
Manufactured In: Canada, United States
Units Affected: 2010 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.