Harrow Eye FRESHKOTE Lubricant Eyedrops Sterile 10mL Recall
Harrow Eye LLC is recalling FRESHKOTE Lubricant Eyedrops because the manufacturer cannot guarantee the product remains sterile. Affected lots are 1X68 and 1X69, with an expiration date of 05/31/2027.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterile product (eyedrops) where sterility assurance has failed. Loss of sterility in ophthalmic products poses a risk of serious infection, meeting the Class II threshold for severity.
Plain-English summary
Harrow Eye LLC is recalling FRESHKOTE Lubricant Eyedrops, Sterile, 0.33 FL OZ (10mL), distributed nationwide in the United States. The recall affects approximately 50,900 units with lot numbers 1X68 and 1X69, expiring 05/31/2027.
The reason for the recall is lack of assurance of sterility. The manufacturer cannot confirm that these lots maintain their sterile formulation.
Consumers who have this product should discontinue use and consult their healthcare provider if they have any concerns. The FDA classified this as a Class II recall.
The recalled product
- Product
- FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
- Manufacturer
- Harrow Eye LLC
- Affected units
- 50,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 1X68
- 1X69
- Exp. Date 05/31/2027.
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereAltaire Recalls FreshKote Lubricant Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2019-11-27
- SevereAltaire Lubricant Eye Drops Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-11-27
- SevereWalgreens Lubricant Eye Drops Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-09-30
- HighFDA Recalls HylaTears Lubricant Eye Drops for Sterility Assurance Issue
FDA (Drugs) · 2024-03-20
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30