Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0456-2022·Announced 2022-02-02

CariFree CTx26 Kit Recalled for Subpotent Sodium Fluoride Content

Dental Alliance Holdings LLC is recalling the CTx26 Kit because it contains less sodium fluoride than listed on the product label. Affected consumers should contact their dentist or healthcare provider.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall for a subpotent drug—a labeling/potency discrepancy with no reported illnesses or injuries. Class III recalls are typically scored 1–2; the moderate score applies because the affected product is an Rx fluoride formulation intended for therapeutic use, where reduced potency represents a material deviation from the labeled therapeutic claim.

Plain-English summary

The CTx26 Kit, manufactured by Dental Alliance Holdings LLC, is being recalled due to subpotency. The product contains less sodium fluoride than stated on its label.

The CTx26 Kit includes three tubes of CariFree CTx4 Gel 5000 (1.1% Neutral Sodium Fluoride Mint, 2 oz), two bottles of CariFree CTx3 Rinse (Mint Anticavity Rinse, 16 fl oz each), and two boxes of CariFree CTx4 Treatment Rinse (4 fl oz each). Affected lots are 312107 and 312108 with expiration date 06/22. The product was distributed nationwide throughout the United States.

Consumers who have purchased this product should not use it and should contact their dentist or healthcare provider for guidance. The subpotent formulation means the product may not provide the intended therapeutic fluoride protection.

The recalled product

Product: 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…
Manufacturer: Dental Alliance Holdings LLC
Category: Drug — Oral Care / Fluoride Gel and Rinse
Hazard: subpotency
mislabeled-potency

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lot#: 312107
312108 Exp. Date 06/22
(contains recalled CariFree CTx4 5000 gel tube lot 142017)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Dental Alliance Holdings LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Dental Alliance Holdings LLC

See all →

Moderate
CTx7 Kit Recalled for Subpotent Sodium Fluoride Content
FDA (Drugs) · 2022-02-02
Moderate
CariFree CTx4 Gel 5000 Subpotent Sodium Fluoride Recall
FDA (Drugs) · 2022-02-02
Moderate
CariFree CTx4 Gel 5000 Sample Boxes Recalled for Subpotent Fluoride
FDA (Drugs) · 2022-02-02
Moderate
CTx21 Kit Dental Products Recalled for Subpotent Sodium Fluoride Content
FDA (Drugs) · 2022-02-02
Low
CariFree CTx4 GEL 5000 Recalled for Subpotent Fluoride Content
FDA (Drugs) · 2022-02-02

Same hazard · subpotency