Freshkote Lubricant Eyedrops, Sterile, 0.33 Fl Oz (10ml), Harrow Eye Llc, Nashville, Tn USA

Recall Summary Freshkote Lubricant Eyedrops (0.33 FL OZ bottles) made by Harrow Eye LLC is being recalled nationwide because the manufacturer cannot guarantee the product is sterile. The product was distributed across all U.S. states and Washington, D.C. This is a Class II recall, which means use of the product could cause serious health problems or death.

Recalling firm
Harrow Eye LLC
Product
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Reason
Lack of Assurance of Sterility
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-04-17
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide within the United States

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/e556df79-e8a2-4775-bdb0-ee22dc52cfb6