Class II · ModerateActive recall
FRESHKOTE LUBRICANT EYEDROPS
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: 1X68, 1X69, Exp. Date 05/31/2027.
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Lack of Assurance of Sterility
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Harrow Eye LLC |
Show the full FDA record
| Full product label | FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA. |
| Recalling firm | Harrow Eye LLC |
| Distribution | Nationwide within the United States |
| Quantity | 50,900 units |
| Recall initiated | 2026-04-17 |
| Report date | 2026-04-29 |
| Recall completed | — |
| Recall number | D-0489-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Nashville TN United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.