Class II · Moderate risk
Ketoconazole Cream
cGMP deviations: Temperature abuse
Xolegel (ketoconazole)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Affected NDC
16110-0080-45
Compare with the code on your package — it is the most precise check available.
Drug: Ketoconazole
- Recalling firm
- Almirall, LLC
- NDC code
- 16110-080-45
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1549-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ketoconazole recalls
See all
Class II · Moderate risk
Ketoconazole USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Reverse Dml Lotion
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Ketoconazole 2%/Hydrocortisone 1.5% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Other failed specification recalls from 2022
All failed specification recalls
Class II · Moderate risk
Epi-Caine
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class I · High risk
Epinephrine
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class I · High risk
Epinephrine
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class III · Low risk
Lacosamide Oral Solution
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
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