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.
What this means for you
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 4f
- Manufacturer
- Dental Alliance Holdings LLC
- 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.
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