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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

Accupac, Inc.: Native Fluoride Toothpaste Recalled for Incorrect Fluoride Labeling

Agency Publication Date: May 26, 2021
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Summary

Approximately 54,264 tubes of Native Fluoride Toothpaste for Sensitive Teeth are being recalled because the product tube may be incorrectly labeled as "Fluoride-Free" when it actually contains fluoride. This labeling error affects two specific lots of the 4.1-ounce (116g) toothpaste distributed nationwide and in Puerto Rico. Consumers should be aware that the product contains 0.243% sodium fluoride despite what may be printed on the individual tube.

Risk

The primary concern is for consumers who specifically seek to avoid fluoride or those who may inadvertently consume too much fluoride because they believe the product is fluoride-free. While fluoride is a standard dental care ingredient, incorrect labeling prevents consumers from making informed decisions about their medication and chemical intake.

What You Should Do

  1. Check your toothpaste tube for Native Fluoride Toothpaste for Sensitive Teeth, 4.1 oz. (116g), with UPC 0 37000 28803 9 and NDC 69423-903-41.
  2. Verify the lot number and expiration date located on the packaging: look for LOT 0317M107 with an expiry of Oct 12 2022, or LOT 1075M107 with an expiry of Feb 16 2023.
  3. If you have an affected tube, even if it is labeled 'Fluoride-Free,' be aware that it DOES contain fluoride.
  4. Contact your healthcare provider or pharmacist if you have concerns about fluoride exposure or if you have experienced any adverse reactions.
  5. Return any unused product to the place of purchase for a refund and contact Accupac, Inc. or the distributor, Native, for further instructions.
  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

💰Full Refund

Contact healthcare provider and return for refund.

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

Affected Products

Product: Native Fluoride Toothpaste for Sensitive Teeth (4.1 oz.)
Model:
NDC: 69423-903-41
UPC Codes:
037000288039
Lot Numbers:
0317M107 (Exp Oct 12 2022)
1075M107 (Exp Feb 16 2023)
Date Ranges: Expiry Oct 12 2022, Expiry Feb 16 2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87944
Status: Resolved
Manufacturer: Accupac, Inc.
Sold By: Native
Manufactured In: United States
Units Affected: 2,261 cases/24 tubes per case = 54,264 tubes
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 · 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.