Reported Oct 5, 2022 · Terminated

Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC…

Almirall, LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ALMIRALL, LLC · 101 Lindenwood Dr Ste 400 · Malvern, PA · 19355-1769

Is this the product you have?

    • Xolegel (ketoconazole) gel 2%
    • 45 gram tubes
    • Rx only
  • Manufactured byDPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Lot codes and dates
  • Lot #: RGAF, Exp. Date 12/2022
Amount recalled
5,315 tubes

Where it was sold

  • Nationwide

Why it was recalled

Failed Viscosity specification: Slightly higher OOS results obtained for viscosity

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 13, 2023 · Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.