Medications & Supplements/Prescription Drugs

CariFree Dental Kits and Gels Recalled for Low Sodium Fluoride Levels

Agency Publication Date: January 26, 2022

Summary

Dental Alliance Holdings LLC (Oral BioTech) is recalling approximately 7,478 units of CariFree CTx4 Gel 5000 and several dental kits containing the gel. The prescription-only medication (1.1% Neutral Sodium Fluoride) was found to have less sodium fluoride than listed on the product label. The recall includes various kits (CTx7, CTx12, CTx21, CTx26, CTx36) and individual gel tubes. No incidents or injuries have been reported to date.

Risk

The drug is subpotent, meaning it contains insufficient active ingredients. In this case, lower-than-expected fluoride levels may reduce the product's effectiveness in preventing dental cavities.

What You Should Do

This recall affects CariFree CTx4 Gel 5000 (1.1% Neutral Sodium Fluoride) and various dental kits containing the gel, including CTx7, CTx12, CTx21, CTx26, CTx36, and CariFree sample boxes.
Identify the product by checking the packaging for NDC code 61578-205-01 and an expiration date of June 2022 (06/22). See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: CariFree CTx4 Gel 5000 (2 oz)

Variants: 1.1% Neutral Sodium Fluoride, Mint Flavor, Individual tubes, 12-pack cases

Lot Numbers:

142017 (Exp 06/22)

NDC:

61578-205-01

Distributed as individual tubes and in 12-pack cases.

Product: CTx7 Kit

Variants: Contains one tube CariFree CTx4 Gel 5000, Contains one bottle CariFree CTx3 Rinse

Lot Numbers:

192107 (Exp 06/22)

192108 (Exp 06/22)

NDC:

61578-205-01

Contains recalled CariFree CTx4 5000 gel tube lot 142017.

Product: CTx12 5000 Kit

Variants: Contains 3 boxes of CariFree CTx4 Gel 5000

Lot Numbers:

142017 (Exp 06/22)

NDC:

61578-205-01

Product: CTx21 Kit

Variants: Contains three tubes of CariFree CTx4 Gel 5000, Contains three bottles of CariFree CTx3 Rinse

Lot Numbers:

272109 (Exp 06/22)

272110 (Exp 06/22)

NDC:

61578-205-01

Contains recalled CariFree CTx4 5000 gel tube lot 142017.

Product: CTx26 Kit

Variants: Contains three tubes of CariFree CTx4 Gel 5000, Contains two bottles of CariFree CTx3 Rinse, Contains two boxes of CTx4 Treatment Rinse

Lot Numbers:

312107 (Exp 06/22)

312108 (Exp 06/22)

NDC:

61578-205-01

Contains recalled CariFree CTx4 5000 gel tube lot 142017.

Product: CTx36 Kit

Variants: Contains three tubes of CariFree CTx4 Gel 5000, Six boxes of CTx4 Treatment Rinse

Lot Numbers:

352110 (Exp 06/22)

352111 (Exp 06/22)

NDC:

61578-205-01

Contains recalled CariFree CTx4 5000 gel tube lot 142017.

Product: CariFree Sample Boxes

Variants: Contains one tube of CariFree CTx4 Gel 5000

Lot Numbers:

492106 (Exp 06/22)

492107 (Exp 06/22)

NDC:

61578-205-01

Contains recalled CariFree CTx4 5000 gel tube lot 142017.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89152

Status: Resolved

Manufacturer: Dental Alliance Holdings LLC

Sold By: Dental Alliance Holdings LLC; Oral BioTech

Manufactured In: United States

Units Affected: 7 products (6612 individual tubes for the 12 pack and 15 individual tubes for the 2 oz. of Lot 142017; 3 single tubes of lot 192107 and 3 single tubes of 192108; 180 single tube of lot 272109 and 180 single tube count of lot 272110; 225 single tube of lot 31217 and 99 single tube of 312108; 90 single tubes of 352110 and 315 single tubes of 352111; 8 single tubes of lot 492106 and 50 single tubes of lot 492107; 360 individual tubes of lot 142017.)

Distributed To: Nationwide

Agency Last Updated: January 28, 2022

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects CariFree CTx4 Gel 5000 (1.1% Neutral Sodium Fluoride) and various dental kits containing the gel, including CTx7, CTx12, CTx21, CTx26, CTx36, and CariFree sample boxes.

Identify the product by checking the packaging for NDC code 61578-205-01 and an expiration date of June 2022 (06/22). See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: CariFree CTx4 Gel 5000 (2 oz)

Variants: 1.1% Neutral Sodium Fluoride, Mint Flavor, Individual tubes, 12-pack cases

Lot Numbers:

142017 (Exp 06/22)

NDC:

61578-205-01

Distributed as individual tubes and in 12-pack cases.

Product: CTx7 Kit

Variants: Contains one tube CariFree CTx4 Gel 5000, Contains one bottle CariFree CTx3 Rinse

Lot Numbers:

192107 (Exp 06/22)

192108 (Exp 06/22)

NDC:

61578-205-01

Contains recalled CariFree CTx4 5000 gel tube lot 142017.

Product: CTx12 5000 Kit

Variants: Contains 3 boxes of CariFree CTx4 Gel 5000

Lot Numbers:

142017 (Exp 06/22)

NDC:

61578-205-01

Product: CTx21 Kit

Variants: Contains three tubes of CariFree CTx4 Gel 5000, Contains three bottles of CariFree CTx3 Rinse

Lot Numbers:

272109 (Exp 06/22)

272110 (Exp 06/22)

NDC:

61578-205-01

Contains recalled CariFree CTx4 5000 gel tube lot 142017.

Product: CTx26 Kit

Variants: Contains three tubes of CariFree CTx4 Gel 5000, Contains two bottles of CariFree CTx3 Rinse, Contains two boxes of CTx4 Treatment Rinse

Lot Numbers:

312107 (Exp 06/22)

312108 (Exp 06/22)

NDC:

61578-205-01

Contains recalled CariFree CTx4 5000 gel tube lot 142017.

Product: CTx36 Kit

Variants: Contains three tubes of CariFree CTx4 Gel 5000, Six boxes of CTx4 Treatment Rinse

Lot Numbers:

352110 (Exp 06/22)

352111 (Exp 06/22)

NDC:

61578-205-01

Contains recalled CariFree CTx4 5000 gel tube lot 142017.

Product: CariFree Sample Boxes

Variants: Contains one tube of CariFree CTx4 Gel 5000

Lot Numbers:

492106 (Exp 06/22)

492107 (Exp 06/22)

NDC:

61578-205-01

Contains recalled CariFree CTx4 5000 gel tube lot 142017.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89152

Status: Resolved

Manufacturer: Dental Alliance Holdings LLC

Sold By: Dental Alliance Holdings LLC; Oral BioTech

Manufactured In: United States

Distributed To: Nationwide

Agency Last Updated: January 28, 2022