Drug & medication recalls Moderate risk

FRESHKOTE LUBRICANT EYEDROPS recalled over sterility concerns

Recall date
April 17, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Harrow Eye LLC recalls FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Recall number
D-0489-2026
FDA classification
Class II
Brand / firm
Harrow Eye LLC
Sold / distributed
Nationwide within the United States

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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