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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Xolegel (ketoconazole) Gel 2% Recalled for Failed Viscosity Specifications

Agency Publication Date: September 29, 2022
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Summary

Approximately 5,315 tubes of Xolegel (ketoconazole) gel 2% have been recalled because the product was found to be thicker than required specifications (failed viscosity). This prescription medication, used to treat skin conditions, was sold in 45-gram tubes. No injuries or incidents have been reported to date, and the recall was initiated after testing showed slightly higher results for viscosity than allowed.

Risk

The product's thickness exceeds standard quality specifications, which could potentially affect the application or dispensing of the gel. No specific health hazards or injuries have been linked to this batch.

What You Should Do

  1. This recall affects 45-gram tubes of Xolegel (ketoconazole) gel 2% labeled with NDC 16110-080-45, lot number RGAF, and an expiration date of 12/2022.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact ALMIRALL, LLC for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Xolegel (ketoconazole) gel 2% (45 gram tube)
Variants: 45 gram tube, Gel, 2%, Rx only
Lot Numbers:
RGAF (Exp. Date 12/2022)
NDC:
16110-080-45

Manufactured by DPT Laboratories, San Antonio, TX 78215.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90877
Status: Resolved
Manufacturer: ALMIRALL, LLC
Sold By: pharmacies
Manufactured In: United States
Units Affected: 5,315 tubes
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.