CTx21 Kit Dental Products Recalled for Subpotent Sodium Fluoride Content
Dental Alliance Holdings LLC is recalling the CTx21 Kit because the product contains less sodium fluoride than stated on the label. Affected lots were distributed nationwide.
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. The hazard is subpotency (lower active ingredient than labeled), which is a formulation/labeling issue. The source text does not report any illnesses, injuries, or adverse events, and the reduced fluoride content represents a loss of efficacy rather than a direct safety threat. This meets the criteria for Moderate severity.
Plain-English summary
Dental Alliance Holdings LLC is recalling the CTx21 Kit due to a subpotency issue. The product contains less sodium fluoride than listed on the product label.
The CTx21 Kit contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint (2 oz / 57 g, NDC 61578-205-01), manufactured by Oral BioTech in Albany, Oregon, and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse (16 fl oz per bottle). The recalled lots are 272109 and 272110, with an expiration date of 06/22. These lots contain the recalled CariFree CTx4 5000 gel tube lot 142017.
The product was distributed nationwide in the United States. A total of 180 units of lot 272109 and 180 units of lot 272110 are affected.
Consumers who have obtained this product should contact Dental Alliance Holdings LLC or consult their healthcare provider for guidance.
The recalled product
- Product
- 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.
- Manufacturer
- Dental Alliance Holdings LLC
- Category
- Drug — Topical / Dental
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 #: 272109
- 272110 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 →Related recalls
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