{"url_path":"/fda/drug/recalls/D-0489-2026","section_key":"summary","section_title":"DRUG Recall: Harrow Eye LLC — FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-17","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0489-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Harrow Eye LLC"},"word_count":64,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0489-2026\n\n**Recalling firm:** Harrow Eye LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-17\n**Report date:** 2026-04-29\n\n## Product\nFRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.\n\n## Reason\nLack of Assurance of Sterility\n\n## Affected lots\nLot #: 1X68, 1X69, Exp. Date 05/31/2027.\n\n## Distribution\nNationwide within the United States"}