April 2026 FDA Recall Drug by Harrow Eye Llc
D-0489-2026 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Harrow Eye Llc on April 17, 2026 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0489-2026

Reason for Recall
Lack of Assurance of Sterility
Initiated
04-17-2026
Reported
04-29-2026
Quantity
50,900 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98766
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Harrow Eye LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.

Batch or Lot Expiration Information

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