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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Topical Products

Sodium Sulfacetamide and Sulfur Cleanser Recalled for Subpotency

Agency Publication Date: May 8, 2024
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Summary

Acella Pharmaceuticals, LLC has recalled 7,104 bottles of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, a prescription medication used for skin conditions. Testing revealed that the drug is subpotent, meaning it may not contain the amount of active ingredients specified on the label. The recall affects 6 oz (170.3 g) bottles with lot number 22085 and an expiration date of August 2, 2024.

Risk

Because the medication is subpotent, it may not be as effective as intended, which could result in the failure to properly treat the skin condition for which it was prescribed.

What You Should Do

  1. This recall affects 6 oz. (170.3 g) bottles of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser with NDC 42192-136-06, lot number 22085, and an expiration date of 08/02/2024.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Acella Pharmaceuticals, LLC for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sodium Sulfacetamide 10% - Sulfur 5% Cleanser (6 oz)
Variants: 10% Sodium Sulfacetamide, 5% Sulfur, Rx Only, 6 oz (170.3 g) Bottle
Lot Numbers:
22085 (Exp 08/02/2024)
NDC:
42192-136-06

Recall #: D-0490-2024. Manufactured for Acella Pharmaceuticals, LLC Alpharetta, GA 30005.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94485
Status: Resolved
Manufacturer: Acella Pharmaceuticals, LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 7104 Bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.