CLASS III Drug recall · Reported 26 Jun 2013 · FDA Enforcement Report
Sodium Sulfacetamide 10% and Sulfur 5% Lotion recalled
Mission Pharmacal is recalling Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (, distributed nationwide in the US. The recall was initiated on 23 Jan 2013 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-602-2013
- FDA event ID
- 64149
- Recalling firm
- Mission Pharmacal, Boerne, TX
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Jan 2013
- FDA classified
- 14 Jun 2013
- Reported
- 26 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 23 Jan 2013 | Recall initiated by company | |
| 14 Jun 2013 | Classified by FDA | +142 days |
| 26 Jun 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
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% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Which lots are affected?
Lot# E112, Exp 05/14 Lot# J062, Exp 09/14
Where was it sold?
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 Mission Pharmacal
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen recalled | Mission Pharmacal | Sterility | Nationwide |
| Drug | CLASS II | Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit recalled | Mission Pharmacal | Sterility | Nationwide |