Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 61578-0205-01 recalled?

CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000…

Yes — this exact package was recalled

7 FDA recalls name the code 61578-0205-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.

Recalls naming this package

Class III · Low risk

CTx36 Kit

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

Terminated Wrong potency / content Dental Alliance Holdings LLC D-0457-2022
Class III · Low risk

CTx26 Kit

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

Terminated Wrong potency / content Dental Alliance Holdings LLC D-0456-2022
Class III · Low risk

CTx21 Kit

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

Terminated Wrong potency / content Dental Alliance Holdings LLC D-0455-2022
Class III · Low risk

CTx7 Kit

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

Terminated Wrong potency / content Dental Alliance Holdings LLC D-0454-2022

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.