Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Apotex Corp.: Guanfacine Extended-Release Tablets Recalled for Quetiapine Fumarate Contamination

Agency Publication Date: April 9, 2021
Share:
Sign in to monitor this recall

Summary

Apotex Corp. is voluntarily recalling 55,620 bottles of Guanfacine Extended-Release Tablets 2 mg because they may contain trace amounts of Quetiapine Fumarate, a different medication. Guanfacine (Intuniv) is typically used to treat ADHD, while Quetiapine Fumarate (Seroquel) is an antipsychotic medication. Consuming an unintended drug can lead to serious side effects and interactions. These affected 100-count bottles were distributed nationwide across the United States.

Risk

The presence of trace amounts of Quetiapine Fumarate in a Guanfacine product poses a risk of drug-to-drug interactions and unexpected side effects such as sedation, dizziness, or more severe reactions depending on the patient's health. No specific injuries or adverse events have been reported in this data, but the contamination represents a failure in manufacturing quality control.

What You Should Do

  1. Check your medication bottle to see if it is Guanfacine Extended-Release Tablets 2 mg with NDC 60505-3928-1 and UPC 3 60505 39281 0.
  2. Look for lot numbers RX1662, RX1663, or RX1664 with an expiration date of 11/2022 on the label.
  3. If you have an affected bottle, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement medication.
  4. Return any unused tablets to your pharmacy or the place of purchase for a refund.
  5. Contact Apotex Corp. directly at 1-800-706-5575 or visit www.apotex.com for further instructions regarding the return of the product.
  6. Report any adverse reactions or quality problems to the FDA's MedWatch program at 1-800-332-1088.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

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

How to: Consumers should return the recalled product to their pharmacy and consult with a medical professional regarding replacement medication.

Affected Products

Product: Guanfacine Extended-Release Tablets 2 mg (100-count bottle)
Model:
NDC 60505-3928-1
UPC Codes:
360505392810
Lot Numbers:
RX1662 (Exp. 11/2022)
RX1663 (Exp. 11/2022)
RX1664 (Exp. 11/2022)
Date Ranges: Expiration 11/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87648
Status: Active
Manufacturer: Apotex Corp.
Sold By: pharmacies
Manufactured In: Canada, United States
Units Affected: 55620 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.