FreshKote Lubricant Eyedrops
Harrow Eye LLC is recalling FreshKote Lubricant Eyedrops (0.33 fl oz) due to lack of assurance of sterility.
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.
Recall at a glance
- Quantity recalled
- 50,900 units
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.
- Lot code
- 1X68, 1X69, 2027
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-05-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification