FDA recall, , Moderate risk
Harrow Eye FreshKote Lubricant Eye Drops
Freshkote Lubricant Eyedrops lack assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Harrow Eye LLC of Nashville, Tennessee recalled Freshkote Lubricant Eyedrops, Sterile, 0.33 FL OZ (10mL), due to a lack of assurance of sterility. The company began the recall on April 17, 2026, and the FDA classified it on April 23, 2026. The product was distributed nationwide within the United States, with 50,900 units affected.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its lot code is listed.
FreshKote Lubricant Eyedrops, Sterile, 0.33 fl oz (10mL), Harrow Eye LLC, Nashville, TN USA.
- Lot code
- 1X68
- 1X69
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Harrow Eye LLCNashville, Tennessee
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98766
- Recall number
- D-0489-2026
- Quantity recalled
- 50,900 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
Listed on Recall Canary
Summary updated
