Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FLUOCINONIDE GEL USP Recalled by Fougera Pharmaceuticals Inc. Due to Failed Stability Specifications: The lots of Fluocinonide Gel...
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 Fougera Pharmaceuticals Inc. directly.
Affected Products
FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)
Quantity: a) 59,622 Tubes; b) 43,178 Tubes
Why Was This Recalled?
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fougera Pharmaceuticals Inc.
Fougera Pharmaceuticals Inc. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report