{"url_path":"/fda/drug/recalls/D-0491-2026","section_key":"summary","section_title":"DRUG Recall: Alcon Research LLC — Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01","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-0491-2026%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":116,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0491-2026\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\nSystane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01\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#: 9T21, Exp Date: 4/30/2026; Lot# 1U63, 2U47, Exp Date: 5/31/2026; Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027; Lot# 9V55, 8V58, 9V39, 9V97, Exp Date: 2/28/2027; Lot# 1W39, 1W40, Exp Date: 3/31/2027; Lot# 1X76, Exp Date: 4/30/2027.\n\n## Distribution\nNationwide within the United States"}