CLASS II Drug recall · Reported 8 Jun 2016 · FDA Enforcement Report
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile recalled
Akorn is recalling Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, distributed nationwide in the US. The recall was initiated on 17 May 2016 and the FDA has classified it as Class II.
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
Timeline
| 17 May 2016 | Recall initiated by company | |
| 29 May 2016 | Classified by FDA | +12 days |
| 8 Jun 2016 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Which lots are affected?
Lot# 5A17A, Expiry 06/16 Lot# 5K21A, Expiry 03/17 Lot# 6A08A, Expiry 06/17
Where was it sold?
Nationwide 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
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| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
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Other Sulfacetamide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Sodium Sulfacetamide 10% - Sulfur 5% Cleanser recalledSodium Sulfacetamide 10 Sulfur 5 Cleanser | Acella Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Sulfacetamide 10%/hydrocortisone 1% Cream recalled by Synergy Rx | Synergy Rx | Sterility | Nationwide |