Desoximetasone Topical Spray (Lupin) – Impurity Specification Failure (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
Brand
Lupin Pharmaceuticals Inc.
Lot Codes / Batch Numbers
K800475 exp. date May 2020 K800477 exp. date June 2020
Products Sold
K800475 exp. date May 2020 K800477 exp. date June 2020
Lupin Pharmaceuticals Inc. is recalling Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured fo due to Failed Impurities/Degradation Specification; high out of specification results observed. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specification; high out of specification results observed
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026