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

Is NDC 16110-0080-45 recalled?

Xolegel (ketoconazole)

Yes — this exact package was recalled

1 FDA recall names the code 16110-0080-45 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

Xolegel (ketoconazole)

Failed Viscosity specification: Slightly higher OOS results obtained for viscosity

Terminated Failed specification Almirall, LLC NDC 16110-080-45 D-1549-2022

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.