Fluocinolone topical solution recalled after failing an impurity specification
Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution 0.01% after an out of specification result for a known impurity.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites an impurity above specification with no stated clinical consequence.
Plain-English summary
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, in 60-mL bottles, distributed by Taro Pharmaceuticals Inc. of Hawthorn, New York, under NDC 51672-1365-4, is being recalled.
The reason given in the enforcement record is failed impurities and degradation specifications: an out of specification result was obtained for the known impurity D.
The recall covers 24,624 bottles from lots AD81290, AD81291, AD81292 and AD81293, all expiring 1/31/2027. Distribution was nationwide within the USA. The FDA has classified the action as Class III, its least serious category.
Patients should not stop using a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Topical corticosteroid
- Affected units
- 24,624
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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