CLASS III Drug recall · Reported 15 May 2024 · FDA Enforcement Report
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser recalled
Acella Pharmaceuticals is recalling Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, distributed nationwide in the US. The recall was initiated on 24 Apr 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0490-2024
- FDA event ID
- 94485
- Recalling firm
- Acella Pharmaceuticals, Alpharetta, GA
- Manufacturer
- Acella Pharmaceuticals, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Apr 2024
- FDA classified
- 8 May 2024
- Reported
- 15 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 24 Apr 2024 | Recall initiated by company | |
| 8 May 2024 | Classified by FDA | +14 days |
| 15 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US and Puerto Rico.
Questions about this recall
Why was it recalled?
Subpotent drug
Which lots are affected?
Lot # 22085 Exp. date 08/02/2024
Where was it sold?
Nationwide in the US and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Acella Pharmaceuticals
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naproxen Oral Suspension, USP, 125 mg recalled by Acella PharmaceuticalsNaproxen | Acella Pharmaceuticals | Lead & Heavy Metals | Nationwide |
| Drug | CLASS II | Doxycycline Hyclate Tablets, USP 100 mg* recalledDoxycycline | Acella Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads recalled | Acella Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Phenytoin Sodium Injection, USP 100 mg recalledPhenytoin Sodium | Acella Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Phenytoin Sodium Injection, USP, 250 mg recalledPhenytoin Sodium | Acella Pharmaceuticals | Packaging Defects | Nationwide |
Other Sulfacetamide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sulfacetamide 10%/hydrocortisone 1% Cream recalled by Synergy Rx | Synergy Rx | Sterility | Nationwide |
| Drug | CLASS II | Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile recalled | Akorn | Sterility | Nationwide |