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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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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Akorn Inc: Desoximetasone Ointment Recalled for Homogeneity and Phase Separation Issues

Agency Publication Date: August 20, 2018
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Summary

Akorn Inc. has voluntarily recalled approximately 153 tubes of Desoximetasone Ointment USP, 0.25%, including 15g and 60g sizes. The medication is being recalled because it failed stability specifications due to issues with homogeneity and phase separation, meaning the ingredients in the ointment have separated and are no longer mixed correctly. Consumers should contact their healthcare provider or pharmacist regarding the use of this product and return any remaining ointment to the place of purchase for a refund.

Risk

When the ointment separates or loses its homogeneity, the active medication may not be distributed evenly throughout the tube. This can result in the patient receiving too much or too little of the drug in a single application, potentially leading to ineffective treatment of the skin condition or an increased risk of localized side effects.

What You Should Do

  1. Locate your Desoximetasone Ointment USP, 0.25% tubes (15g or 60g sizes) and check the packaging for NDC 61748-206-15 (15g) or NDC 61748-206-60 (60g).
  2. Check the tube or box for Lot #34871 with an expiration date of 12/2017.
  3. If your ointment matches this lot and expiration date, stop using the medication immediately.
  4. Contact your healthcare provider or pharmacist to discuss your treatment and obtain a replacement prescription if necessary.
  5. Return any unused tubes to the pharmacy or place of purchase to receive a full refund.
  6. Contact Akorn Inc. at 1-888-723-3332 for further instructions regarding this recall.
  7. For additional questions or to report adverse events, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmaceutical refund and medical guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Desoximetasone Ointment USP, 0.25% (15 g tube)
Model:
NDC 61748-206-15
Recall #: D-0152-2017
Lot Numbers:
348716 (Exp. 12/2017)
Date Ranges: Expiration date 12/2017
Product: Desoximetasone Ointment USP, 0.25% (60 g tube)
Model:
NDC 61748-206-60
Recall #: D-0152-2017
Lot Numbers:
348716 (Exp. 12/2017)
Date Ranges: Expiration date 12/2017

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75628
Status: Resolved
Manufacturer: Akorn Inc
Sold By: Versapharm Inc.; pharmacies nationwide
Manufactured In: United States
Units Affected: a) 62 tubes and b) 91 tubes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.