FDAClass II · Drug · Recall D-0489-2026 · Recalled April 29, 2026

FRESHKOTE LUBRICANT EYEDROPS recall — Harrow Eye LLC

Agency report date: April 29, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: FRESHKOTE LUBRICANT EYEDROPS
Company / brand: Harrow Eye
Lot / serial / date codes: Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
Distribution: Nationwide within the United States

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Lack of Assurance of Sterility

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: FRESHKOTE LUBRICANT EYEDROPS recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0489-2026
Brand: All Harrow Eye recalls
Classification: Class II
Units affected: 50,900 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

FRESHKOTE LUBRICANT EYEDROPS recall status

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

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved July 28, 2026 at 11:00 PM UTC.

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