Sodium Sulfacetamide 10 Sulfur 5 Cleanser Rinse
FDA Recall NDC 42192-136
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sodium Sulfacetamide 10 Sulfur 5 Cleanser (NDC 42192-136). A significant event, classified as Class III, was initiated on Apr 24, 2024 by Acella Pharmaceuticals, Llc. The reported reason for this action was: "Subpotent drug"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent drug
Apr 24, 2024
May 15, 2024
7104 Bottles
Recall Profile & Regulatory Data
Event ID
94485
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US and Puerto Rico.
Termination Date
Dec 22, 2025
Product Description
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
Batch or Lot Expiration Information
Lot# 22085 Exp. date 08/02/2024
Affected Packages Involved in this Recall
42192-136-06Product
42192-136-08Product
42192-136-12Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
