Warning
Harrow Eye LLC Recalls FRESHKOTE LUBRICANT EYEDROPS
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0489-2026Drug / Pharmaceutical
Harrow Eye LLC Recalls FRESHKOTE LUBRICANT EYEDROPS
Harrow Eye LLC · Class II — Moderate Risk
Product Description
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Reason for Recall
Lack of Assurance of Sterility
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Harrow Eye LLC initiated the recall on April 17, 2026 affecting 50,900 units. Lack of Assurance of Sterility. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Harrow Eye LLC for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.