Recall: D-0489-2026

Class II - Potentially Harmful

Class IIClassification

2026-04-17Initiated

OngoingStatus

Harrow Eye LLCFirm

Product

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

Reason

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.