Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fluocinolone Acetonide Topical Solution Recalled by Teva Pharmaceuticals USA Due to Failed Impurities and Degradation Specifications and Subpotent Drug:...
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 Teva Pharmaceuticals USA directly.
Affected Products
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
Quantity: 27,803 bottles
Why Was This Recalled?
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Teva Pharmaceuticals USA
Teva Pharmaceuticals USA has 196 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report