Class II · Moderate risk
Fluocinonide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Is Fluocinonide recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Fluocinonide (12 total). Check the affected lots below.
Most common reason: Stability / shelf life (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluocinonide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Fluocinonide recalls in 2026
3 initiated in 2026, 12 in total — newest first
Class II · Moderate risk
Fluocinonide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk
Fluocinonide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk
Fluocinonide Topical Solution USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Fluocinonide Gel USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Fluocinonide Cream USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class III · Low risk
Fluocinonide Ointment USP 0.05%
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Class III · Low risk
Fluocinonide Gel USP
Cross contamination with other products: traces of Dapsone were found in the finished product.
Class III · Low risk
Fluocinonide Cream UPS
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Class II · Moderate risk
Fluocinonide 0.05% Solution
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
All fluocinonide Products
Lack of Processing Controls
Class II · Moderate risk
Fluocinonide Gel USP
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>.
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