Class III · Low risk
Fluocinolone Acetonide Solution Topical Solution USP
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Is Fluocinolone recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Fluocinolone (36 total). Check the affected lots below.
Most common reason: Wrong potency / content (21 of these recalls)
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.
Fluocinolone recalls on record
none so far in 2026; 36 on record, newest first
Class II · Moderate risk
Fluocinolone Acetonide Oil
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class II · Moderate risk
DermOtic Oil
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class II · Moderate risk
Formula 82M
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82F
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube
Lack of Processing Control
Class II · Moderate risk
Fluocinolone Acetonide Topical Solution
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Class II · Moderate risk
Fluocinolone Acetonide Topical Solution
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Class II · Moderate risk
Fluocinolone Acetonide Topical Solution
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class II · Moderate risk
Fluocinolone Acetonide Topical Oil
Subpotent Drug
Class III · Low risk
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only
Chemical Contamination
Class II · Moderate risk
Tri-Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Tri-Bleaching Cream Hq
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Tri-Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Tri-Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HI-LITE Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class III · Low risk
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01%
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01%
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
ROYAL PHARMACEUTICALS 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.
Class III · Low risk
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.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.