Desoximetasone Ointment (Akorn Inc) – Stability Failure (2016)
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 Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
Brand
Akorn Inc
Lot Codes / Batch Numbers
Lot #348716 (exp. 12/2017)
Products Sold
Lot #348716 (exp. 12/2017)
Akorn Inc is recalling Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206 due to Failed Stability Specifications; out-of specification value for homogeneity / phase separation.. 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 Stability Specifications; out-of specification value for homogeneity / phase separation.
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