Class II · Moderate risk
Hydrocortisone Cream
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Is Hydrocortisone recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Hydrocortisone (70 total). Check the affected lots below.
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 on record
none so far in 2026; 70 on record, newest first
Class II · Moderate risk
Hydrocortisone Cream
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Hydrocortisone Cream With Aloe
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Hydrocortisone Cream With Aloe
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Perrigo Sterile Neo-Polycin HC
Lack of Assurance of Sterility
Class II · Moderate risk
Hydrocortisone Acetate Suppositories
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Hydrocortisone and Acetic Acid Otic Solution
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Class II · Moderate risk
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk
Cortaid 12-Hour Advanced Anti-itch Cream
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class II · Moderate risk
Cortaid Maximum Strength Cream
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class II · Moderate risk
Cortaid Intensive Therapy Cooling Spray
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class II · Moderate risk
Hydrocortisone Ointment
Failed Stability Specifications
Class II · Moderate risk
Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class I · High risk
PIYANPING Anti-Itch
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Class III · Low risk
Hydrocortisone Lotion
Superpotent Drug: above specification for the assay.
Class II · Moderate risk
Sulfacetamide 10%/Hydrocortisone 1% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Hydrocortisone 2.5% With Aloe Vera Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Quad Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Malek's Magic Plus
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Malek's Magic
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Gentle Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Firm and Fade
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
DUO Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Calming Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
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