CLASS III Drug recall · Reported 7 Dec 2022 · FDA Enforcement Report
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads recalled
Acella Pharmaceuticals is recalling Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, distributed nationwide in the US. The recall was initiated on 14 Nov 2022 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-0074-2023
- FDA event ID
- 91150
- Recalling firm
- Acella Pharmaceuticals, Alpharetta, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 Nov 2022
- FDA classified
- 1 Dec 2022
- Reported
- 7 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 14 Nov 2022 | Recall initiated by company | |
| 1 Dec 2022 | Classified by FDA | +17 days |
| 7 Dec 2022 | Published in enforcement report | +6 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: Out of specification for assay at the end-of-shelf-life 24-month period.
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 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Which lots are affected?
Lot#: 21084, 21085, Exp 06/30/2023
Where was it sold?
USA Nationwide
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 5% Cleanser recalledSodium Sulfacetamide 10 Sulfur 5 Cleanser | 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 |