FRESHKOTE LUBRICANT EYEDROPS, 10mL recall — Harrow Eye LLC (Class II)

Regulatory snapshot

Reason reported by FDA

Lack of Assurance of Sterility

5 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

2 identifying values matched by exact pattern in the 14-word product description above; each is a literal substring of it.

Reading this record

Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual.

Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Harrow Eye LLC (1 indexed records) aggregates this firm across datasets.

• What a Class II recall means
• What "Ongoing" recall status means
• FDA recall classifications: Class I, II and III
• How to read an FDA drug recall record

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0489-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.