Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Fluocinolone Acetonide Solution Topical Solution USP Recalled by SUN PHARMACEUTICAL INDUSTRIES INC Due to Failed Impurities/Degradation Specifications: Out of specification result was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SUN PHARMACEUTICAL INDUSTRIES INC directly.
Affected Products
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
Quantity: 24,624 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SUN PHARMACEUTICAL INDUSTRIES INC
SUN PHARMACEUTICAL INDUSTRIES INC has 86 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report