FDA Recall D-0489-2026
Harrow Eye LLC · Nashville, TN
Class II Ongoing 27 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Reason for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0489-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2026-04-17
- Classified by FDA Center
- 2026-04-23
- FDA published
- 2026-04-29
- Recalling firm
- Harrow Eye LLC
- Firm location
- Nashville, TN
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.