Harrow Eye recalls Freshkote lubricant eye drops over lack of assurance of sterility
The recalled Freshkote Lubricant Eyedrops (0.33 FL OZ, 10mL) were recalled because there is a lack of assurance that they are sterile, and 50,900 units were distributed nationwide in the United States.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
- Company
- Harrow Eye LLC
- Hazard
- Lack of Assurance of Sterility
- Units
- 50,900 units
- Where sold
- Nationwide within the United States
- FDA classification
- Class II · Ongoing
- Classified by FDA
- April 23, 2026
- Recall started
- April 17, 2026
- FDA enforcement report
- April 29, 2026
- Identifiers
- Codes: Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
- FDA recall number: D-0489-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
- Reason for recall
- Lack of Assurance of Sterility
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide within the United States
- Quantity
- 50,900 units
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