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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

Medline Industries Inc: SparkleFresh Fluoride Toothpaste Recalled for Microbial Contamination

Agency Publication Date: November 2, 2018
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Summary

Medline Industries is recalling 994,756 tubes of SparkleFresh Fluoride Toothpaste (sodium monofluorophosphate 0.76%) because the product may be contaminated with microorganisms. This recall affects multiple sizes, including 17 g, 24 g, and 42.5 g tubes sold nationwide and in Puerto Rico. The issue was discovered after testing revealed microbial contamination in non-sterile product batches, which could lead to infections. If you have this toothpaste, you should contact a healthcare provider and return the product to the place of purchase for a refund.

Risk

The use of contaminated toothpaste can introduce harmful microorganisms into the mouth and bloodstream, potentially causing serious infections, particularly in individuals with weakened immune systems or existing oral sores.

What You Should Do

  1. Check your SparkleFresh Fluoride Toothpaste tubes for the following Lot Numbers and Expiration Dates: Lot 102920C (Exp 10/29/2020), Lot 111220C (Exp 11/11/2020), Lot 111620D (Exp 11/16/2020), Lot 111420D (Exp 11/14/2020), or Lot 111720C (Exp 11/17/2020).
  2. Verify the NDC and product numbers on the packaging: 17 g tube (NDC 53329-083-92, product NONTP6I), 24 g tube (NDC 53329-083-93, product NONTP85I), 42.5 g tube (NDC 53329-083-21, product NONTP15I), or 24 g tube (NDC 53329-081-93, product DGN1000).
  3. Immediately stop using the affected toothpaste to avoid the risk of infection.
  4. Contact your healthcare provider or pharmacist for guidance if you have used this product and have concerns about your health.
  5. Return any unused product to the place of purchase for a refund and contact Medline Industries at 1-800-MEDLINE for further instructions.
  6. For additional questions or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare provider 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: SparkleFresh Fluoride Toothpaste (17 g tube)
Model:
NDC 53329-083-92
NONTP6I
Lot Numbers:
102920C (Exp 10/29/2020)
111220C (Exp 11/11/2020)
Product: SparkleFresh Fluoride Toothpaste (24 g tube)
Model:
NDC 53329-083-93
NONTP85I
Lot Numbers:
111620D (Exp 11/16/2020)
Product: SparkleFresh Fluoride Toothpaste (42.5 g tube)
Model:
NDC 53329-083-21
NONTP15I
Lot Numbers:
111420D (Exp 11/14/2020)
Product: SparkleFresh Fluoride Toothpaste (24 g tube)
Model:
NDC 53329-081-93
DGN1000
Lot Numbers:
111720C (Exp 11/17/2020)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81381
Status: Resolved
Manufacturer: Medline Industries Inc
Manufactured In: Malaysia, United States
Units Affected: 994,756 tubes
Distributed To: Nationwide
Agency Last Updated: November 15, 2018

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.