Fougera Recalls Desonide Ointment Tubes Due to Labeling Mixup
Fougera Pharmaceuticals is recalling 14,665 tubes of Desonide Ointment because unit boxes may contain tubes labeled as Ketoconazole Cream.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling mixup, which is a significant risk but does not involve a structural defect or reported serious injury.
Plain-English summary
Fougera Pharmaceuticals Inc. is recalling 14,665 tubes of Desonide Ointment, 0.05%, 60 grams, prescription only. The recall involves Lot GC9231 and Lot GC9232, both with an expiration date of 05/2019. The product was distributed nationwide.
The recall was initiated due to a labeling mixup. Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment that are labeled as Ketoconazole Cream. This discrepancy creates a risk of medication error.
Patients and healthcare providers should check their inventory for the affected lots. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund. Consumers should not use the product if there is any uncertainty regarding the labeling.
The recalled product
- 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
- Manufacturer
- Fougera Pharmaceuticals Inc.
- Category
- Drug — Topical Steroid
- Affected units
- 14,665
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot GC9231 (exp. 05/2019)
- Lot GC9232 (exp. 05/2019)
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Fougera Pharmaceuticals Inc.
See all →- ModerateFougera Recalls Fluocinonide Gel Due to Residual Solvent Concerns
FDA (Drugs) · 2014-11-19
- LowFougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns
FDA (Drugs) · 2014-07-23
- LowFougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns
FDA (Drugs) · 2014-07-23
- LowFougera Recalls Triamcinolone Acetonide Cream Due to Labeling Error
FDA (Drugs) · 2014-03-19
- LowFougera Recalls Ketoconazole Cream Due to Out-of-Specification Degradants
FDA (Drugs) · 2014-02-05
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02