FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.

FDA recall notice · announced April 29, 2026 · Harrow Eye

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.

Reason for recall

Lack of Assurance of Sterility

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
Quantity: 50,900 units
Status: Ongoing
Products in this recall event:
- FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA. (D-0489-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.