Class III · Low risk
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Subpotent drug
Is Sulfacetamide recalled?
Not under an active recall.
Sulfacetamide was recalled 16 times in the past — all now closed. Most recent: Apr 24, 2024.
Most common reason: Wrong potency / content (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sulfacetamide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Sulfacetamide recalls on record
none so far in 2026; 16 on record, newest first
Class III · Low risk
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class II · Moderate risk
CSF-HC Otic Insufflation Capsule
CGMP Deviations
Class II · Moderate risk
CSF Otic Insufflation Capsule
CGMP Deviations
Class III · Low risk
Sodium Sulfacetamide
Subpotency: one product for active ingredient assay and another one for preservative assay
Class II · Moderate risk
Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP
Lack of Assurance of Sterility
Class II · Moderate risk
Blephamide
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Class II · Moderate risk
Sulfacetamide 10%/Hydrocortisone 1% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Reverse Dml Lotion
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Clobetasol 0.05% in Olea Base
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Sulfacetamide Sodium Ophthalmic Solution
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Class II · Moderate risk
Blephamide
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class II · Moderate risk
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class III · Low risk
Sodium Sulfacetamide 10% and Sulfur 5% Lotion
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
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.