{"url_path":"/fda/drug/recalls/D-0501-2026","section_key":"summary","section_title":"DRUG Recall: Thea Pharma, Inc. — Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-23","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0501-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Thea Pharma, Inc."},"word_count":104,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0501-2026\n\n**Recalling firm:** Thea Pharma, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-23\n**Report date:** 2026-05-06\n\n## Product\nSimilasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11\n\n## Reason\nLack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.\n\n## Affected lots\nLot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.\n\n## Distribution\nNationwide within the United States"}