Sodium Sulfacetamide 10% recall
FDA recall D-0490-2024 · initiated Apr 24, 2024
Acella Pharmaceuticals, LLC recalled Sodium Sulfacetamide 10% in Apr 2024 — an FDA Class III recall (D-0490-2024) because Subpotent drug.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Subpotent drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 7104 Bottles
Details
- Product
- 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
- Recalling company
- Acella
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US and Puerto Rico.
- Initiated
- Apr 24, 2024
- FDA report date
- May 15, 2024
Frequently asked
- Was Sodium Sulfacetamide 10% recalled?
- Acella Pharmaceuticals, LLC recalled Sodium Sulfacetamide 10% in Apr 2024 — an FDA Class III recall (D-0490-2024) because Subpotent drug. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Sodium Sulfacetamide 10% recalled?
- Per the FDA enforcement record, the reason for recall D-0490-2024 was: Subpotent drug
- Is a recalled Sodium Sulfacetamide 10% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sodium Sulfacetamide 10% are affected?
- Distributed: Nationwide in the US and Puerto Rico.. The recall covers these lots — Lot # 22085 Exp. date 08/02/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0490-2024.