FDAClass IIApril 29, 2026

Freshkote Lubricant Eyedrops recall: Sterility Concern

FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.

Why was Freshkote Lubricant Eyedrops recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 1X68, 1X69, Exp. Date 05/31/2027.

Product
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Recalling firm
Harrow Eye LLC
Quantity
50,900 units
Distribution
Nationwide within the United States
Recall date
April 29, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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