Class III · Low risk
Xolegel (ketoconazole)
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Is Ketoconazole recalled?
Not under an active recall.
Ketoconazole was recalled 10 times in the past — all now closed. Most recent: Sep 16, 2022.
Most common reason: Sterility / contamination (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ketoconazole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Ketoconazole recalls on record
none so far in 2026; 10 on record, newest first
Class II · Moderate risk
Ketoconazole Cream
cGMP deviations: Temperature abuse
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.
Class II · Moderate risk
Ketoconazole active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Ketoconazole Cream
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Class III · Low risk
Ketoconazole Shampoo
Subpotent
Class III · Low risk
Fougera Ketoconazole Cream 2%
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
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