CariFree CTx4 Gel 5000 Subpotent Sodium Fluoride Recall
Dental Alliance Holdings LLC is recalling CariFree CTx4 Gel 5000 fluoride gel tubes because they contain less sodium fluoride than stated on the label. The affected product is CTx12 5000 Kit lot 142017.
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 subpotency issue (lower active ingredient than labeled). No illnesses, injuries, or hospitalizations are reported in the source. The hazard is a labeling/potency discrepancy rather than a contamination or acute safety risk, consistent with a Moderate severity classification.
Plain-English summary
Dental Alliance Holdings LLC is recalling the CTx12 5000 Kit, which contains 3 boxes of CariFree CTx4 Gel 5000 gel tubes (1.1% Neutral Sodium Fluoride Mint, 2 oz / 57 g, Rx only, NDC 61578-205-01), because the product is subpotent—meaning it contains less sodium fluoride than listed on the product label.
The affected product is lot 142017 with expiration date 06/22. A total of 360 individual tubes were distributed nationwide throughout the United States.
Consumers should discontinue use of the product and consult their healthcare provider or dentist if they have questions about their fluoride treatment. The manufacturer is Oral BioTech, Albany, Oregon 97321.
The recalled product
- Product
- CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
- Manufacturer
- Dental Alliance Holdings LLC
- Category
- Drug — Topical Fluoride
- Hazard
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 (2)
- Lot #: 142017
- exp. Date 06/22
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
Same manufacturer · Dental Alliance Holdings LLC
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FDA (Drugs) · 2022-02-02
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