Gentamicin Sulfate Ophthalmic Solution — Class II drug recall D-0414-2019
Terminated recall by Akorn, Inc., reported 2019-02-06, distributed nationwide. Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
| Recall number | D-0414-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2018-10-08 |
| Classified | 2019-01-28 |
| Reported by FDA | 2019-02-06 |
| Terminated | 2022-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 149,159 |
| Reason classes | specification failure |
| NDC | 17478-0283-10 |
| Lot numbers | 02/19, 5K42A, 6C02A, 7D47A |
| Expiration dates | 2018-09, 2020-03 |
Product
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
Reason for recall
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
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-0414-2019. 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.