CTx26 Kit — Class III drug recall D-0456-2022
Terminated recall by Dental Alliance Holdings LLC, reported 2022-02-02, distributed nationwide. Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
| Recall number | D-0456-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dental Alliance Holdings LLC, Albany, OR, United States |
| Recall initiated | 2021-12-03 |
| Classified | 2022-01-26 |
| Reported by FDA | 2022-02-02 |
| Terminated | 2022-08-11 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| NDC | 61578-0205-01 |
| Lot numbers | 06/22, 142017, 312107, 312108 |
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 4fl.oz. Carifree CTx4 Treatment Rinse.
Reason for recall
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0456-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.