Desonide Ointment (Fougera) - Labeling Mix-up (2017)
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
Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60
Brand
Fougera Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lot GC9231 (exp. 05/2019), Lot GC9232 (exp. 05/2019)
Products Sold
Lot GC9231 (exp. 05/2019); Lot GC9232 (exp. 05/2019)
Fougera Pharmaceuticals Inc. is recalling Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Ph due to Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream. 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
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
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