Class II · Moderate risk
Brightening Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
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
Acne Solution
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Ketoconazole 2%/Hydrocortisone 1.5% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class III · Low risk
Novacort Gel Sample Packets
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Class III · Low risk
Hydrocortisone and acetic acid otic solution
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Class III · Low risk
Acetasol HC
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Class II · Moderate risk
All hydrocortisone Products
Lack of Processing Controls
Class II · Moderate risk
GRx HiCort 25
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Solu-Cortef
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class III · Low risk
Hydrocortisone and Acetic Acid Otic Solution
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Class II · Moderate risk
Hydrocortisone 1.6 mg/0.5 mL Susp
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Hydrocortisone Sodium Succinate active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Hydrocortisone Micronized active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Hydrocortisone base active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Hydrocortisone active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Locoid (hydrocortisone butyrate 0.1%)
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Class III · Low risk
Hydrocortisone Butyrate Cream 0.1%
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Class II · Moderate risk
Hydrocortisone
Labeling: Label Mixup: HYDROCORTISONE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: carBAMazepine ER, Tablet, 200 mg, NDC 51672412401, Pedigree: AD60272_7, EXP: 5/22/2014; guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: W002728, EXP: 4/30/2014; glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: AD21790_10, EXP: 2/28/2014; ACARBOSE, Tablet, 25 mg
Class II · Moderate risk
HYDROCORTISONE Tablet
Labeling: Label Mixup; HYDROCORTISONE Tablet, 5 mg may be potentially mislabeled as ORPHENADRINE CITRATE ER, Tablet, 100 mg, NDC 43386048024, Pedigree: W002962, EXP: 6/11/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003045, EXP: 6/12/2014.
Class III · Low risk
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
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