Class III โ€” Low Risk

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

CTx21 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

CTx21 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 three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.

Quantity: 180 single tube of lot 272109 and 180 single tube count of lot 272110

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