⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a
very recent recall may be missing. Everything shown is accurate as of the last checked time on this page —
for anything time-critical, confirm with the official sources linked below.
FDAClass II · Drug · Recalled April 29, 2026
FRESHKOTE LUBRICANT EYEDROPS recall — Harrow Eye LLC
Hazard: Lack of Assurance of Sterility
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- D-0489-2026
- Brand
- Harrow Eye
- Classification
- Class II
- Units affected
- 50,900 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Affected products
Companies & origin
- Recalling firm location
- Nashville, TN, United States
- Firm address
- 1a Burton Hills Blvd Ste 200, N/A, 37215-6187
Identifying details (verbatim from the notice)
- Product codes / lots
- Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
- Distribution
- Nationwide within the United States
- Firm notified the public via
- Letter
- FDA event ID
- 98766
- Recall initiated
- April 17, 2026
- FDA classified
- April 23, 2026
- FDA report date
- April 29, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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