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.
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: 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.
Related recalls
Same brand · FLUOCINOLONE ACETONIDE
- ModerateFluocinolone Acetonide Ear Drops Recalled Due to Failed Specification
FDA (Drugs) · 2024-01-31
- ModerateLupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurities
FDA (Drugs) · 2019-01-30
- ModerateLupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurity Failures
FDA (Drugs) · 2018-10-31
- ModerateLyne Laboratories Recalls Subpotent Fluocinolone Acetonide Topical Oil
FDA (Drugs) · 2018-05-02
- ModerateLyne Laboratories Recalls Subpotent Fluocinolone Acetonide Ear Drops
FDA (Drugs) · 2018-05-02
Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighBudesonide inhalation ampules contain black and brown specks and particles
FDA (Drugs) · 2026-06-17
- SevereDoxorubicin liposome injection vials contain glass particulate matter
FDA (Drugs) · 2026-06-17
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17