{"url_path":"/fda/drug/recalls/D-0721-2026","section_key":"summary","section_title":"DRUG Recall: Rohto-Mentholatum (Vietnam) Co., Ltd. — Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-07-14","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0721-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Rohto-Mentholatum (Vietnam) Co., Ltd."},"word_count":96,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0721-2026\n\n**Recalling firm:** Rohto-Mentholatum (Vietnam) Co., Ltd.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-14\n**Report date:** 2026-07-29\n\n## Product\nRohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2\n\n## Reason\nLack of Assurance of Sterility\n\n## Affected lots\nLot #: 4G1V, Exp 2027/06; 4J1V, 512VB 2027/09; 5D1V, 2028/03; 5G1V, 512VB 2028/06;  512V, 512VB 2028/08\n\n## Distribution\nNationwide within the United States"}