Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Yes — there is an active recall. 1 ongoing FDA recall mention Fluocinolone (36 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluocinolone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Failed Content Uniformity Specifications; at the 18 month time point.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Subpotent; 22 month stability timepoint
Subpotent; 12 month stability timepoint
Subpotent; fluocinolone acetonide.
Subpotent; fluocinolone acetonide
Subpotent; fluocinolone acetonide
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