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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
Personal Care & Cosmetics/Oral Care

Sunstar Guangzhou Ltd.: Sunstar GUM Toothpaste Recalled for Manufacturing Deviations

Agency Publication Date: May 4, 2020
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Summary

Sunstar Guangzhou Ltd. has recalled approximately 260,000 tubes of Sunstar GUM Toothpaste (3 g tubes) due to deviations from Current Good Manufacturing Practice (cGMP) requirements. These small sample-sized tubes were manufactured in Japan and packaged in China before being distributed in Florida. Consumers who have these specific travel-sized tubes should stop using them and contact a healthcare professional or the manufacturer for guidance.

Risk

The recall was initiated because the manufacturing and packaging process did not meet federal quality standards, which could lead to inconsistent product quality or safety concerns. While no specific injuries or adverse reactions have been reported, failure to follow good manufacturing practices means the safety and purity of the toothpaste cannot be guaranteed.

What You Should Do

  1. Identify your product by checking for 3 gram (3 g) tubes of Sunstar GUM Toothpaste labeled with NDC 53050-0002-01.
  2. Check the packaging for the following affected lot numbers and expiration dates: Lot 20180621 (Exp. 2020-06-21), Lot 20180827 (Exp. 2020-08-27), and Lot 20190115 (Exp. 2021-01-15).
  3. Stop using the toothpaste immediately if it matches the affected lot numbers and expiration dates.
  4. Contact your healthcare provider or pharmacist if you have concerns about using this product or if you have experienced any irritation or issues.
  5. Return any unused product to the place of purchase for a refund and contact Sunstar Guangzhou Ltd. for further instructions regarding the disposal or return of the tubes.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Standard FDA Drug Recall remedy

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

Affected Products

Product: Sunstar GUM Toothpaste (3 g tubes)
Model:
NDC 53050-0002-01
Lot Numbers:
20180621 (Exp. 2020-06-21)
20180827 (Exp. 2020-08-27)
20190115 (Exp. 2021-01-15)
Date Ranges: Expiration 2020-06-21, Expiration 2020-08-27, Expiration 2021-01-15

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85127
Status: Resolved
Manufacturer: Sunstar Guangzhou Ltd.
Manufactured In: Japan, China
Units Affected: 260,000 tubes
Distributed To: Florida

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 · 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.