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

Class I - Dangerous
💊 Drugs Recalled: September 16, 2022 ALMIRALL Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: RGAF, Exp. Date 12/2022
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
ALMIRALL, LLC
Reason for Recall:
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot #: RGAF, Exp. Date 12/2022

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1549-2022