Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Failed Stability Specifications
Is Sulfur recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Sulfur (18 total). Check the affected lots below.
Most common reason: Other (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sulfur. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Sulfur recalls on record
none so far in 2026; 18 on record, newest first
Class III · Low risk
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Subpotent drug
Class II · Moderate risk
Albuterol (Pf/Sulfuric Acid/Dye Free)
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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
Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Sulfur Ointment 10%
Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Class II · Moderate risk
Sulfur Colloid Reaction Vial 1.0 mL
Lack of Processing Controls.
Class II · Moderate risk
Sulfur 5% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class III · Low risk
sulfur8 medicated LIGHT FORMULA
Subpotent Drug: failed at the 3 and 6 month stability time points.
Class II · Moderate risk
Lipo-B MMC I
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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
sulfur8
Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.
Class II · Moderate risk
Mic Ultra-Sulfur Free 30ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Mic Ultra-Sulfur Free 10ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Mic Ultra 50ml- Sulfur Free w/Lido
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Mic Ultra 50ml- Sulfur Free
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
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.
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