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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

ORL Kids Mouthwash and Toothpaste Recalled for Manufacturing Deviations

Agency Publication Date: January 5, 2026
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Summary

Signature Formulations, LLC is recalling 2,028 units of ORL Kids mouthwash and toothpaste due to significant deviations from Current Good Manufacturing Practice (cGMP) regulations. This voluntary recall includes 570 bottles of bubblegum-flavored mouthwash and 1,458 containers of bubblegum-flavored natural toothpaste. These products were distributed exclusively in Arizona. Consumers who have these products should stop using them and follow the disposal or return instructions provided.

Risk

The products were manufactured under conditions that did not meet quality and safety standards, which could potentially lead to contamination or inconsistent product quality.

What You Should Do

  1. Check your products for ORL Kids Mouthwash (16.9 oz) with lot number 250505P9 and expiration date 05/27.
  2. Check your products for ORL Kids Natural Toothpaste (4 oz) with lot number 250520P4 and expiration date 05/27.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Signature Formulations, LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: ORL Kids Mouthwash, Bubblegum Flavor (16.9 oz)by ORL Labs, LLC
Variants: Bubblegum Flavor, 16.9 oz (500ml)
Lot Numbers:
250505P9 (Exp. 05/27)

Recall #: D-0252-2026

Product: ORL Kids Natural Toothpaste, Bubblegum Flavor (4 oz)by ORL Labs, LLC
Variants: Bubblegum Flavor, 4 oz (120ml)
Lot Numbers:
250520P4 (Exp. 05/27)

Recall #: D-0253-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98131
Status: Active
Manufacturer: Signature Formulations, LLC
Sold By: Retailers in Arizona
Manufactured In: United States
Units Affected: 2 products (570 bottles; 1,458 containers)
Distributed To: Arizona

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.