Topical Corticosteroid Drug Recalled for Out-of-Specification Impurity
Sun Pharmaceutical is recalling Fluocinolone Acetonide Solution topical solution distributed nationwide due to manufacturing quality issues. Testing found an impurity level that exceeded specifications.
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: This is an FDA Class III recall of a prescription topical corticosteroid due to a manufacturing quality defect—a known impurity detected at out-of-specification levels. No illnesses or injuries have been reported.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, a prescription topical corticosteroid. The recall was initiated because testing identified the known impurity D in samples from the affected lots at levels exceeding the established specifications.
The recall affects 24,624 bottles distributed nationwide in the United States. The affected lots are AD81290, AD81291, AD81292, and AD81293, all with an expiration date of January 31, 2027. The product is supplied by Taro Pharmaceuticals Inc., located in Hawthorn, New York.
The recalled product
- Product
- FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Topical Corticosteroid
- Hazard
- impurity
- quality-defect
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 (4)
- Lot #: AD81290
- AD81291
- AD81292 and AD81293
- Exp. Date 1/31/2027
Distribution
Distributed nationwide across the United States.
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