← FDA ENFORCEMENT
D-0489-2026Class II

Harrow Eye LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Harrow Eye LLC
Product type
Drug
Status
Ongoing
Report date
2026-04-29
Distribution
Nationwide within the United States
Firm state
TN
Product quantity
50,900 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →