Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Is Hydrocortisone recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Hydrocortisone (70 total). Check the affected lots below.
Most common reason: Sterility / contamination (16 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydrocortisone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Hydrocortisone recalls in 2026
5 initiated in 2026, 70 in total — newest first
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class III · Low risk
Essential Calming Skin Gel
Subpotent Drug
Class III · Low risk
Skin Rehab
Subpotent Drug
Class III · Low risk
Remedy Gel
Subpotent Drug
Class II · Moderate risk
Rapidol Maximum Strength
CGMP Deviations
Class III · Low risk
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class III · Low risk
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class II · Moderate risk
Hydrocortisone and Acetic Acid Otic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE
Lack of sterility assurance
Class II · Moderate risk
Fs Hydrocortisone Cream 1 Oz Sku 910321 Cortizone 10 Creme 0.5…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Hydrocortisone Ointment USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
Hydrocortisone Butyrate Lotion
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Hydrocortisone Butyrate Lotion
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Hydrocortisone Butyrate Lotion 0.1%
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk
Proctofoam HC
cGMP deficiencies
Class II · Moderate risk
CSF-HC Otic Insufflation Capsule
CGMP Deviations
Class II · Moderate risk
HYDROCORTISONE 1% 30gm cream
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Hydrocortisone Acet 30mg 12
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Proctofoam HC
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Hydrocortisone butyrate Cream
SUBPOTENT DRUG
Class II · Moderate risk
Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube
Lack of Processing Control
Class II · Moderate risk
Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream 100 gm tube
Lack of Processing Control
Class II · Moderate risk
Hydrocortisone and Acetic Acid Otic Solution
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
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