CLASS II ONGOING Drug recall · Reported 29 Apr 2026 · FDA Enforcement Report
Freshkote Lubricant Eyedrops, Sterile, Harrow Eye Llc recalled
Harrow Eye is recalling Freshkote Lubricant Eyedrops, Sterile, Harrow Eye Llc, Nashville, TN Usa, distributed nationwide in the US. The recall was initiated on 17 Apr 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0489-2026
- FDA event ID
- 98766
- Recalling firm
- Harrow Eye, Nashville, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Apr 2026
- FDA classified
- 23 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 17 Apr 2026 | Recall initiated by company | |
| 23 Apr 2026 | Classified by FDA | +6 days |
| 29 Apr 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.