Why it was recalled
Lack of Assurance of Sterility
Product description
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Lot numbers, UPCs & expiration codes
Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0489-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 17, 2026
- FDA report date
- Apr 29, 2026
- Quantity
- 50,900 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Harrow Eye LLC
Original FDA data
Every field from FDA enforcement report D-0489-2026, exactly as published.
Show all FDA fields
- City
- Nashville
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 98766
- Address
- 1a Burton Hills Blvd Ste 200
- Code information
- Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
- Postal code
- 37215-6187
- Report date
- Apr 29, 2026
- Product type
- Drugs
- Recall number
- D-0489-2026
- Classification
- Class II
- Recalling firm
- Harrow Eye LLC
- Product quantity
- 50,900 units
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 17, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 23, 2026