FRESHKOTE LUBRICANT EYEDROPS — Class II drug recall D-0489-2026
Ongoing recall by Harrow Eye LLC, reported 2026-04-29, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0489-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Harrow Eye LLC, Nashville, TN, United States |
| Recall initiated | 2026-04-17 |
| Classified | 2026-04-23 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 50,900 units |
| Reason classes | sterility |
| Lot numbers | 1X68, 1X69 |
| Expiration dates | 2027-05-31 |
Product
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Reason for recall
Lack of Assurance of Sterility
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-0489-2026. 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.