FDA recall D-0489-2026
Harrow Eye LLC · Class II · drug
Product
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Key facts
- Status
- Ongoing
- Initiation date
- 2026-04-17
- Report date
- 2026-04-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Nashville, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0489-2026