Harrow Eye LLC — FDA Compliance Timeline

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Harrow Eye LLC has 1 FDA event on file. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2026-04-29, Argus HQ recorded an FDA recall for Harrow Eye LLC, rated "high" severity in Argus HQ's classification: Harrow Eye LLC — Class II recall: FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashvi…. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

Does Argus HQ track new FDA actions for Harrow Eye LLC automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Harrow Eye LLC is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Harrow Eye LLC?

1 total: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Harrow Eye LLC?

April 29, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Harrow Eye LLC had product recalls?

Yes, 1 recall on file. See the full history below for each one.

Related enforcement actions

• Harrow Eye LLC — Class II recall: FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashvi… →

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