FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Summary
The FDA issued a Class II for FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashvi by Harrow Eye LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0489-2026
Action Date
2026-04-29
Status
Ongoing
Category
drug
Product Description
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Lot/Code Info: Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
Quantity Affected: 50,900 units
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-17
Company
Nashville, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 82 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Harrow Eye LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Harrow Eye LLC have FDA actions?
This is the only FDA action we have on record for Harrow Eye LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0489-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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