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

Freshkote Lubricant Eyedrops Recall Summary Harrow Eye LLC is recalling Freshkote Lubricant Eyedrops (0.33 FL OZ bottles) distributed nationwide because the company cannot guarantee the product is sterile. This Class II recall affects products sold across all U.S. states and Washington, D.C.

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/dd7e91bd-012d-4242-90e8-d898a80ef151