Xolegel (ketoconazole) Tubes recalls

The FDA has published 1 recall involving Xolegel (ketoconazole) Tubes since 2022. The latest was reported on 5 Oct 2022. Most were for potency & assay. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2022

Last 12 months0reported

Class I00% of total

Ongoing0latest 5 Oct 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 0 0%Class III 1 100%

Why xolegel (ketoconazole) tubes is recalled

Potency & Assay1100%

Companies

Almirall1100%

By year

20221100%

All xolegel (ketoconazole) tubes recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
5 Oct 2022Drug	CLASS III	Xolegel (ketoconazole) gel 2% tubes recalled by Almirall	Almirall	Potency & Assay	Nationwide

Should you stop taking Xolegel (ketoconazole) Tubes?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.