Sulfacetamide Sodium Ophthalmic Solution — Class II drug recall D-0949-2016
Terminated recall by Akorn, Inc., reported 2016-06-08, distributed nationwide. Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
| Recall number | D-0949-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2016-05-17 |
| Classified | 2016-05-29 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2017-07-21 |
| Distributed | Nationwide (US) |
| Quantity | 57,920 bottles |
| Reason classes | sterility, specification failure |
| NDC | 17478-0221-12 |
| Lot numbers | 03/17, 06/16, 06/17, 5A17A, 5K21A, 6A08A |
Product
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
Reason for recall
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0949-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.