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FreshKote Lubricant Eyedrops
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DRUG RECALLMODERATE

FreshKote Lubricant Eyedrops

Harrow Eye LLC is recalling FreshKote Lubricant Eyedrops (0.33 fl oz) due to lack of assurance of sterility.

What to do

Stop using this product immediately. Do not apply to your eyes. Contact Harrow Eye LLC or your healthcare provider if you have used this product and experience eye pain, redness, discharge, or vision changes.

Posted
Updated
Recall No.
D-0489-2026
Agency
Firm
Harrow Eye LLC
Recall ID
98766
Status
ONGOING

Why it was recalled

Harrow Eye LLC is recalling FreshKote Lubricant Eyedrops, Sterile, 0.33 fl oz (10 mL) bottles due to lack of assurance of sterility. Sterile eyedrops that do not meet sterility standards pose a risk of serious eye infection.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

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

Recall #
D-0489-2026

Where it was sold

Distributed nationwide.

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Editorial summary by Recall Canary · last updated 2026-05-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification