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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