Gentamicin Sulfate Ophthalmic Solution — Class II drug recall D-0993-2019
Terminated recall by Akorn, Inc., reported 2019-03-20, distributed nationwide. Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total
| Recall number | D-0993-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2019-02-22 |
| Classified | 2019-03-11 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2022-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 51,456 bottles |
| Reason classes | specification failure |
| NDC | 17478-0283-10 |
| Lot numbers | 7B71A |
| Expiration dates | 2020-01 |
Product
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
Reason for recall
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
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-0993-2019. 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.