{"url_path":"/fda/drug/recalls/D-0492-2026","section_key":"summary","section_title":"DRUG Recall: Alcon Research LLC — GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-21","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0492-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Alcon Research LLC"},"word_count":101,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0492-2026\n\n**Recalling firm:** Alcon Research LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-21\n**Report date:** 2026-05-06\n\n## Product\nGenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.\n\n## Reason\nLack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.\n\n## Affected lots\nLot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026;  7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.\n\n## Distribution\nNationwide within the United States"}