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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 Corp.: Aripiprazole Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: November 18, 2020
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Summary

Apotex Corp. has recalled 3,744 bottles of Aripiprazole (generic Abilify) 15 mg tablets because the medication failed to meet dissolution specifications during testing. This defect means the tablets may not dissolve properly in the body, which can prevent the medication from being absorbed at the intended rate. These prescription tablets were distributed nationwide in 30-count and 1,000-count bottles with expiration dates in February 2021.

Risk

If the medication does not dissolve as specified, the patient may not receive the full intended dose of the drug, potentially leading to a loss of symptom control for the conditions being treated.

What You Should Do

  1. Check your prescription bottle for Aripiprazole Tablets, USP 15 mg. Specifically, look for 1000-count bottles with NDC 60505-2675-8 (Lot PZ6716, Exp. 02/2021) or 30-count bottles with NDC 60505-2675-3 (Lot PZ6715, Exp. 02/2021).
  2. Contact your healthcare provider or pharmacist immediately to discuss whether you should continue taking the medication or if a replacement is necessary.
  3. Return any unused or remaining tablets from the affected lots to your pharmacy to receive a refund.
  4. Contact Apotex Corp. at 1-800-706-5575 or visit their website for further instructions regarding this recall.
  5. If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Aripiprazole Tablets, USP 15 mg (1000 count bottle)
Model:
NDC 60505-2675-8
D-0106-2021
Lot Numbers:
PZ6716 (Exp. 02/2021)
Date Ranges: Expiration 02/2021
Product: Aripiprazole Tablets, USP 15 mg (30 count bottle)
Model:
NDC 60505-2675-3
D-0106-2021
Lot Numbers:
PZ6715 (Exp. 02/2021)
Date Ranges: Expiration 02/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86736
Status: Resolved
Manufacturer: Apotex Corp.
Sold By: Pharmacies
Manufactured In: Canada, United States
Units Affected: a)552 bottles; b) 3192 bottles
Distributed To: Nationwide
Agency Last Updated: November 24, 2020

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.