Medications & Supplements/Topical Products

Lupin Pharmaceuticals Inc.: Desoximetasone Topical Spray Recalled for High Impurities and Degradation

Agency Publication Date: March 3, 2020

Summary

Lupin Pharmaceuticals Inc. is recalling 876 bottles of Desoximetasone Topical Spray, 0.25% (2.5 mg) because testing revealed high levels of impurities and product degradation that exceeded approved limits. Using a medication with excessive impurities or degraded ingredients can lead to reduced effectiveness or unintended reactions. This recall affects 100 mL prescription bottles distributed nationwide with expiration dates in May and June 2020. Consumers are advised to contact their healthcare provider or pharmacist for guidance on their treatment.

Risk

The medication failed stability specifications due to high out-of-specification results for impurities and degradation products. This chemical failure means the drug's potency and safety profile may be compromised, potentially resulting in skin irritation or a failure to treat the underlying condition.

What You Should Do

Check your prescription bottle label to see if you have Desoximetasone Topical Spray, 0.25% in 100 mL bottles.
Verify the lot number and expiration date on the packaging. This recall specifically involves lot K800475 with an expiration date of May 2020 and lot K800477 with an expiration date of June 2020.
Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if a replacement prescription is necessary.
Return any unused product from these specific lots to the pharmacy where you purchased it for a refund.
Contact the manufacturer, Lupin Pharmaceuticals Inc., at their Baltimore location for further instructions regarding the return process.
If you have additional questions or wish to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and consultation

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

Affected Products

Product: Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone (100 mL bottle)

Model:

D-0866-2020

Lot Numbers:

K800475 (exp. date May 2020)

K800477 (exp. date June 2020)

Date Ranges: May 2020, June 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85015

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 876 bottles

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 · 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.

Summary

Risk

What You Should Do

Check your prescription bottle label to see if you have Desoximetasone Topical Spray, 0.25% in 100 mL bottles.

Verify the lot number and expiration date on the packaging. This recall specifically involves lot K800475 with an expiration date of May 2020 and lot K800477 with an expiration date of June 2020.

Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if a replacement prescription is necessary.

Return any unused product from these specific lots to the pharmacy where you purchased it for a refund.

Contact the manufacturer, Lupin Pharmaceuticals Inc., at their Baltimore location for further instructions regarding the return process.

If you have additional questions or wish to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.