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 MonitoringReason 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 openFDA enforcement API. 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.