Class III โ€” Low Risk

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

CariFree sample boxes 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

CariFree sample boxes, contains one tube 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.

Quantity: 8 single tubes of lot 492106 and 50 single tubes of lot 492107

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