Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Xolegel (ketoconazole) gel 2% Recalled by ALMIRALL, LLC Due to Failed Viscosity specification: Slightly higher OOS results obtained...

Date: September 16, 2022
Company: ALMIRALL, LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ALMIRALL, LLC directly.

Affected Products

Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45

Quantity: 5,315 tubes

Why Was This Recalled?

Failed Viscosity specification: Slightly higher OOS results obtained for viscosity

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ALMIRALL, LLC

ALMIRALL, LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report