Use caution Drug recall · FDA · Published December 3, 2021

CariFree CTx7 Kit Recall: Subpotent Sodium Fluoride Gel

Dental Alliance Holdings LLC recalls specific lots of the CTx7 Kit because the CTx4 gel contains less sodium fluoride than labeled.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0454-2022Drug CariFree ›

Use caution until it’s fixed

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Take action

Contact the company

Recalling firmDental Alliance Holdings LLC812 Water Ave Ne · Albany, OR 97321-3074

✎ GovInfoNow plain-language explainer

Dental Alliance Holdings LLC is recalling specific lots of the CTx7 Kit, which includes a tube of CariFree CTx4 Gel and a bottle of CariFree CTx3 Rinse. The recall is necessary because the CTx4 gel contains less sodium fluoride than stated on the product label. This means the product may not provide the expected anticavity protection for users. Read more at govinfonow.com/recall/35487-carifree-ctx7-kit-recall-subpotent-sodium-fluoride-gel.

Source Summary by GovInfoNow · govinfonow.com/recall/35487-carifree-ctx7-kit-recall-subpotent-sodium-fluoride-gel · Updated October 10, 2026 · FDA enforcement record: FDA #D-0454-2022

Cite this page

“CariFree CTx7 Kit Recall: Subpotent Sodium Fluoride Gel.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35487-carifree-ctx7-kit-recall-subpotent-sodium-fluoride-gel. Based on FDA recall #D-0454-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0454-2022%22&limit=1).

Dental Alliance Holdings LLC voluntarily recalled CTx7 Kits containing CariFree CTx4 Gel due to subpotent drug hazards, according to the FDA on December 3, 2021. The product contains less sodium fluoride than listed on the label.

How to tell if you have it

Brand: CariFree
Product: CTx7 Kit CariFree CTx4 Gel
NDC: 61578-205-01
Lot #: 192107 and lot 192108
Exp. Date: 06/22 (contains recalled CariFree CTx4 5000 gel tube lot 142017)
Quantity: 3 single tubes of lot 192107 and 3 single tubes of 192108

The hazard

The CTx7 Kit contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only and one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. The hazard is that the product contains less sodium fluoride than listed on the product label.

Context

GovInfoNow's records show other recent recalls include Sun Pharmaceutical Diclofenac Gel Recall (2026-01-27) and Keystone Dental City Topical Anesthetic Gel Recall (2026-05-21). Keystone Burkhart Anesthetic Gel Recall also occurred on 2026-05-21.

How to tell if you have this one

Check if you have a CTx7 Kit manufactured by Oral BioTech (Albany, Oregon) containing CariFree CTx4 Gel. Look for lot numbers 192107 or 192108 on the kit, which contain the recalled gel tube lot 142017. The expiration date on these kits is 06/22.

Brand
CariFree
Category
Drug

FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Terminated
Distribution
Distributed nationwide with the United States

Recall number	Product, codes & lots	Quantity
D-0453-2022	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 Distributed in 12-pk/cases; Lot #: 142017 Exp. Date 06/22	6612 individual tubes for the 12 pack and 15 individual tubes for the 2 oz. of Lot 142017
D-0454-2022	CTx7 Kit, contains one tube 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 one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.; Lot #: 192107 and lot 192108 Exp. Date 06/22 (contains recalled CariFree CTx4 5000 gel tube lot 142017)	3 single tubes of lot 192107 and 3 single tubes of 192108
D-0455-2022	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.; Lot #: 272109, 272110 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)	180 single tube of lot 272109 and 180 single tube count of lot 272110
D-0456-2022	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.; Lot#: 312107, 312108 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)	225 single tube of lot 31217 and 99 single tube of 312108
D-0457-2022	CTx36 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 six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.; Lot #: 352110, 352111 Exp. Date 06/22; (contains recalled CariFree CTx4 5000 gel tube lot 142017)	90 single tubes of 352110 and 315 single tubes of 352111
D-0458-2022	CariFree sample boxes, contains one tube 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.; Lot #: 492106, 492107 Exp. Date 06/22 (contains recalled CariFree CTx4 5000 gel tube lot 142017).	8 single tubes of lot 492106 and 50 single tubes of lot 492107
D-0459-2022	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.; Lot #: 142017, exp. Date 06/22	360 individual tubes of lot 142017.

Based on the official FDA remedy

What to do — step by step

Check Your Product
Verify if your CTx7 Kit contains CariFree CTx4 Gel with lot number 142017 inside lots 192107 or 192108.
Contact Manufacturer
The recall record does not specify a remedy, return process, or refund procedure; contact Dental Alliance Holdings LLC for further instructions.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Distributed nationwide with the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

Dec 3, 2021Firm started the recall
Jan 26, 2022FDA classified it Class III
Feb 2, 2022Published in FDA’s Enforcement Report
Aug 11, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/35487-carifree-ctx7-kit-recall-subpotent-sodium-fluoride-gel">CariFree CTx7 Kit Recall: Subpotent Sodium Fluoride Gel (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0454-2022 (December 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0454-2022 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.