Lupin Pharmaceuticals Desoximetasone Topical Spray Recall

Why it was recalled

Failed Impurities/Degradation Specification; high out of specification results observed

Product description

Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD

Lot numbers, UPCs & expiration codes

K800475 exp. date May 2020 K800477 exp. date June 2020

Where it was sold

Product was distributed throughout the United States.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0866-2020
Classification: Class II
Status: Terminated
Recall initiated: Feb 19, 2020
FDA report date: Mar 11, 2020
Quantity: 876 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Lupin Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0866-2020, exactly as published.

Show all FDA fields

City: Baltimore
State: MD
Status: Terminated
Country: United States
Event ID: 85015
Address: Harborplace Tower
Address (line 2): 111 S Calvert St Fl 21st
Code information: K800475 exp. date May 2020 K800477 exp. date June 2020
Postal code: 21202-6174
Report date: Mar 11, 2020
Product type: Drugs
Recall number: D-0866-2020
Classification: Class II
Recalling firm: Lupin Pharmaceuticals Inc.
Product quantity: 876 bottles
Termination date: Jun 3, 2021
Reason for recall: Failed Impurities/Degradation Specification; high out of specification results observed
Voluntary / mandated: Voluntary: Firm initiated
Product description: Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
Distribution pattern: Product was distributed throughout the United States.
Recall initiation date: Feb 19, 2020
Initial firm notification: Letter
Center classification date: Mar 3, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0866-2020, published Mar 11, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.