Prescription skin cleanser recalled nationwide due to subpotency
Acella Pharmaceuticals recalled 7,104 bottles of Sodium Sulfacetamide 10% Sulfur 5% Cleanser nationwide because the product contained less active ingredient than labeled. The recall was terminated in December 2025.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III voluntary recall with no reported illnesses or injuries. The rubric specifies that Class III recalls are typically scored 1 or 2. This scores as Moderate (2) because it is a voluntary precautionary recall by the manufacturer, and subpotency affects product efficacy rather than presenting an immediate safety hazard.
Plain-English summary
Acella Pharmaceuticals, LLC initiated a voluntary recall of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser in April 2024 due to subpotency. The product is a prescription topical skin cleanser distributed nationwide in the US and Puerto Rico. The recall affected 7,104 bottles of the 6 oz formula with Lot #22085 and expiration date 08/02/2024 (NDC 42192-136-06 and related package codes).
Subpotency means the product contained less active ingredient than specified on the label, reducing its intended efficacy. The FDA classified this as a Class III recall on May 8, 2024. The recall was terminated on December 22, 2025.
Patients who received this product should consult their healthcare provider to discuss potential effects on their skin condition treatment. Return unused product from Lot #22085 to your pharmacy.
The recalled product
- Product
- SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR)
- Brand
- SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER
- Manufacturer
- Acella Pharmaceuticals, LLC
- Category
- Drug — Topical Cleanser
- Hazard
- subpotency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 22085 Exp. date 08/02/2024
Distribution
Distributed nationwide across the United States.
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