Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

CTx26 Kit Recalled by Dental Alliance Holdings LLC Due to Subpotent Drug: Product contains less Sodium Fluoride than...

Date: December 3, 2021
Company: Dental Alliance Holdings LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Dental Alliance Holdings LLC directly.

Affected Products

CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.

Quantity: 225 single tube of lot 31217 and 99 single tube of 312108

Why Was This Recalled?

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Dental Alliance Holdings LLC

Dental Alliance Holdings LLC has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report