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Medium risk Drugs & MedicationsClass II

FreshKote Lubricant EyeDrops Recall

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

Updated April 17, 2026

FreshKote Lubricant EyeDrops are being recalled because the manufacturer cannot guarantee the product's sterility. Non-sterile eyedrops can cause serious eye infections.

Is the Harrow Eye LLC recalled? Yes. This product was recalled by FDA on April 17, 2026. Details below.

What is recalled

FreshKote Lubricant EyeDrops, Sterile, 0.33 FL OZ (10 mL), made by Harrow Eye LLC, Nashville, TN USA.

Am I affected

You're affected if you have a bottle of FreshKote Lubricant EyeDrops labeled as 0.33 FL OZ (10 mL) from Harrow Eye LLC.

What to do right now

Stop using this product immediately. Do not put it in your eyes. Contact the seller or your pharmacy where you purchased the eyedrops for instructions on how to return or discard the bottle. If you have already used this product and your eyes feel irritated, red, or painful, contact your eye doctor or healthcare provider.

The hazard

Lack of Assurance of Sterility

Brands affected

Harrow Eye LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0489-2026
Classification
Class II
Recalled
April 17, 2026
Read the official notice

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