FRESHKOTE LUBRICANT EYEDROPS recall (Harrow Eye LLC)
DrugClass IIOngoing
Summary: Harrow Eye LLC is recalling FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.. Reason: Lack of Assurance of Sterility.
What is being recalled
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Why
Lack of Assurance of Sterility
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0489-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 17, 2026 |
| Reported | April 29, 2026 |
| Company | Harrow Eye LLC |
| Company location | Nashville, TN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 50,900 units |
More recalls from Harrow Eye LLC · all drug recalls · recalls from April 2026