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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

The Harvard Drug Group: Aripiprazole 15 mg Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: December 1, 2020
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Summary

The Harvard Drug Group is recalling 841 cartons of Aripiprazole Tablets USP (15 mg), a prescription medication used to treat certain mental and mood disorders. The recall was initiated because the tablets failed dissolution testing, meaning they were out of specification and may not dissolve properly in the body. These tablets were manufactured by Apotex, Inc. and distributed under the Major Pharmaceuticals brand in unit dose cartons containing 30 tablets each. Consumers should contact their healthcare provider to discuss concerns about their medication and can return any unused product to their pharmacy for a refund.

Risk

When a drug fails dissolution specifications, the medication may not be absorbed by the body as intended. This can lead to a lower amount of the active drug in the patient's system, potentially making the treatment less effective or causing a recurrence of symptoms.

What You Should Do

  1. Check your medication packaging for Aripiprazole Tablets, USP, 15 mg distributed by Major Pharmaceuticals with NDC 0904-6512-04.
  2. Verify the lot numbers and expiration dates on the carton: look for lot numbers T02520 or T02637, both with an expiration date of 02/2021.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you find you have the affected medication.
  4. Return any unused tablets from these specific lots to the pharmacy where they were purchased to receive a refund.
  5. Contact The Harvard Drug Group or Major Pharmaceuticals at 17177 N. Laurel Park Dr. Ste 233, Livonia, MI 48152 for further instructions regarding this recall.
  6. For 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

Medical consultation and product 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 (30 tablets per unit dose carton)
Model:
NDC 0904-6512-04
Recall #: D-0114-2021
Lot Numbers:
T02520 (exp 02/2021)
T02637 (exp 02/2021)
Date Ranges: 02/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86787
Status: Resolved
Manufacturer: The Harvard Drug Group
Sold By: Major Pharmaceuticals
Manufactured In: Canada, United States
Units Affected: 841 cartons
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.