{"recall":{"id":"fda-drug-99440","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Rohto-Mentholatum (Vietnam) Co., Ltd. recalls 8 products","firm":"Rohto-Mentholatum (Vietnam) Co., Ltd.","date":"2026-07-14","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1","code":"Lot #: 3H1V, Exp. Date 2026/07; 3J1V, 3J2V, Exp. Date 2026/09; 3K1V, Exp. Date 2026/10; 4A1V, 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, Exp. Date 2027/01; 4G1V, 4G2V, 4G3V, Exp. Date 2027/06; 4I1V, 4I2V, 4I2VA Exp. Date 2027/08; 4J1V, 4J2V, Exp. Date 2027/09; 4K2V, 4K3V, 4K4V Exp. Date2027/10; 5B1V, 5B2V, 5B3V, Exp. Date 2028/01; 5D1V, Exp. Date 2028/03; 5E1V, 5E2V, 5E3V, Exp. Date 2028/04; 5H1V, Exp. Date 2028/07; 5I1V, Exp. Date 2028/08; 5J1V, 5J2V, Exp. Date 2028/09; 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V,Exp. Date 2028/11; 6A1V, 6A2V, Exp. Date 2028/12; 6B1V, Exp. Date 2029/01 & Lot 6C1V, Exp. Date 2029/02.","quantity":"1.033,266 cartons","number":"D-0715-2026","classification":"Class II"},{"name":"Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1","code":"Lot #: 3H2V, 3H3V, Exp. Date 2026/07; 3J1V, 3J3V, 3J4V, 3J5V, Exp. Date 2026/09; 3K1V, 3K2V, Exp. Date 2026/10; 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, 4B3V, Exp. Date 2027/01; 4F1V, 4F2V, 4F2V, 4F3V, 4F4V, Exp. Date 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, Exp. Date 2027/06; 4H1V, Exp. Date 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, Exp. Date 2027/08.","quantity":"6076306 cartons","number":"D-0716-2026","classification":"Class II"},{"name":"Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2","code":"Lot #: 3H1V, Exp. Date2026/07; 3J2V, Exp. Date 2026/09; 4A1V, 4A1VA, Exp. Date 2026/12; 4G1V, Exp. Date 2027/06; 4I3V, Exp. Date 2027/08; 5A1V, Exp. Date 2027/12; 5B3V, Exp. Date2028/01; 5G3V, Exp. Date 2028/06; 5J1V, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6A1V, Exp. Date 2028/12; 6B4V, Exp. Date 2029/01; 6C2V, Exp. Date 2029/02.","quantity":"499,673 cartons","number":"D-0717-2026","classification":"Class II"},{"name":"Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1","code":"Lot #: 3H1V, 3H1VA, Exp. Date 2025/07; 3J1V, 3J2V, Exp. Date 2025/09; 3K1V, Exp. Date 2025/10; 4F1V, Exp. Date 2027/05; 4F1VA, Exp. Date 2027/05; 4H1V, Exp. Date 2027/07; 4I1V, Exp. Date 2027/08; 4K1V, 4K2V,Exp. Date 2027/10; 5A1V, 5A2V, Exp. Date 2027/12; 5D1V, Exp. Date 2028/03; 5E1V, Exp. Date2028/04; 5J1V, 5J2V, Exp. Date 2028/09; 6B1V, Exp. Date 2029/01; 6C1V, 6C1VA, 6C1VB, Exp. Date 2029/02.","quantity":"1,278,457 cartons","number":"D-0718-2026","classification":"Class II"},{"name":"Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1","code":"Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09","quantity":"65219 cartons","number":"D-0719-2026","classification":"Class II"},{"name":"Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1","code":"Lot #: 4G1VA, Exp. Date 2027/06; 4J1VA, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12; 5D1VA, Exp. Date 2028/03; 5G1VA, Exp. Date 2028/06; 512V, 512V, 512VB Exp. Date 2028/08; 5L2VA, 512VB 2028/11.","quantity":"97201 cartons","number":"D-0720-2026","classification":"Class II"},{"name":"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","code":"Lot #: 4G1V, Exp 2027/06; 4J1V, 512VB 2027/09; 5D1V, 2028/03; 5G1V, 512VB 2028/06; 512V, 512VB 2028/08","quantity":"353 cartons","number":"D-0721-2026","classification":"Class II"},{"name":"Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1","code":"Lot #: 3J1V, Exp. Date 2026/09; 4A1V, Exp. Date 2026/12; 4G1V, 4G2V, Exp. Date 2027/06; 4I1V, Exp. Date 2027/08; 4JIV, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12 ; 5B1V, Exp. Date 2028/01; 5F1V, Exp. Date 2028/05; 5F1VA, Exp. Date 2028/05; 5H1V & 5H1VA, Exp. Date 2028/07; 5J1V, 5J1VA, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6B1V, Exp. Date 2029/01.","quantity":"2910148 cartons","number":"D-0722-2026","classification":"Class II"}],"reason":"Lack of Assurance of Sterility","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide within the United States","nationwide":true,"states":[],"units":"1.033,266 cartons; 6076306 cartons; 499,673 cartons; 1,278,457 cartons; 65219 cartons; 97201 cartons; 353 cartons; 2910148 cartons","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99440","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"a9a190929df2bc68","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99440","record":[{"status":"Ongoing","city":"Ho Chi Minh","state":"N/A","country":"Vietnam","classification":"Class II","openfda":{"application_number":["M018"],"brand_name":["ROHTO"],"generic_name":["HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE"],"manufacturer_name":["The Mentholatum Company"],"product_ndc":["10742-8146"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"substance_name":["HYPROMELLOSE, UNSPECIFIED","TETRAHYDROZOLINE HYDROCHLORIDE","ZINC SULFATE, UNSPECIFIED FORM"],"rxcui":["1098640"],"spl_id":["597621d4-3b06-4f1d-e063-6294a90a7073"],"spl_set_id":["43e690e4-b381-46e3-838c-33aef5bdadde"],"package_ndc":["10742-8146-1","3107420108"],"is_original_packager":[true],"upc":["0310742010862","310742010862"],"unii":["3NXW29V3WO","0YZT43HS7D","89DS0H96TB"]},"product_type":"Drugs","event_id":"99440","recalling_firm":"Rohto-Mentholatum (Vietnam) Co., Ltd.","address_1":"No. 16 Vsip, Street No. 5","address_2":"Vietnam Singapore Industrial Park","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0715-2026","product_description":"Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1","product_quantity":"1.033,266 cartons","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260714","center_classification_date":"20260723","report_date":"20260729","code_info":"Lot #: 3H1V, Exp. Date 2026/07; 3J1V, 3J2V, Exp. Date 2026/09; 3K1V, Exp. Date 2026/10;  4A1V, 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, Exp. Date 2027/01; 4G1V, 4G2V, 4G3V, Exp. Date 2027/06; 4I1V, 4I2V, 4I2VA Exp. Date 2027/08; 4J1V, 4J2V, Exp. Date 2027/09; 4K2V, 4K3V, 4K4V Exp. Date2027/10; 5B1V, 5B2V, 5B3V, Exp. Date 2028/01; 5D1V, Exp. Date 2028/03; 5E1V, 5E2V, 5E3V, Exp. Date 2028/04; 5H1V, Exp. Date 2028/07; 5I1V, Exp. Date 2028/08; 5J1V, 5J2V, Exp. Date 2028/09; 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V,Exp. Date 2028/11; 6A1V,  6A2V, Exp. Date 2028/12; 6B1V, Exp. Date 2029/01 & Lot 6C1V, Exp. Date 2029/02."},{"status":"Ongoing","city":"Ho Chi Minh","state":"N/A","country":"Vietnam","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99440","recalling_firm":"Rohto-Mentholatum (Vietnam) Co., Ltd.","address_1":"No. 16 Vsip, Street No. 5","address_2":"Vietnam Singapore Industrial Park","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0716-2026","product_description":"Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127,  Made in Vietnam, UPC 310742011012,  NDC 10742-8158-1","product_quantity":"6076306 cartons","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260714","center_classification_date":"20260723","report_date":"20260729","code_info":"Lot #: 3H2V, 3H3V, Exp. Date 2026/07; 3J1V,  3J3V, 3J4V, 3J5V, Exp. Date 2026/09; 3K1V, 3K2V, Exp. Date 2026/10; 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, 4B3V, Exp. Date 2027/01; 4F1V, 4F2V, 4F2V, 4F3V, 4F4V, Exp. Date 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, Exp. Date 2027/06; 4H1V, Exp. Date 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, Exp. Date 2027/08."},{"status":"Ongoing","city":"Ho Chi Minh","state":"N/A","country":"Vietnam","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99440","recalling_firm":"Rohto-Mentholatum (Vietnam) Co., Ltd.","address_1":"No. 16 Vsip, Street No. 5","address_2":"Vietnam Singapore Industrial Park","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0717-2026","product_description":"Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2","product_quantity":"499,673 cartons","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260714","center_classification_date":"20260723","report_date":"20260729","code_info":"Lot #: 3H1V, Exp. Date2026/07; 3J2V, Exp. Date 2026/09;  4A1V, 4A1VA, Exp. Date 2026/12; 4G1V, Exp. Date 2027/06; 4I3V, Exp. Date 2027/08; 5A1V, Exp. Date 2027/12; 5B3V, Exp. Date2028/01; 5G3V, Exp. Date 2028/06; 5J1V, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6A1V, Exp. Date 2028/12; 6B4V, Exp. Date 2029/01; 6C2V, Exp. Date 2029/02."},{"status":"Ongoing","city":"Ho Chi Minh","state":"N/A","country":"Vietnam","classification":"Class II","openfda":{"application_number":["M018"],"brand_name":["ROHTO OPTIC GLOW"],"generic_name":["NAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOL"],"manufacturer_name":["The Mentholatum Company"],"product_ndc":["10742-8160"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"substance_name":["NAPHAZOLINE HYDROCHLORIDE","POVIDONE, UNSPECIFIED","PROPYLENE GLYCOL"],"rxcui":["2531299"],"spl_id":["5975efd5-9a8b-48f9-e063-6394a90a3d02"],"spl_set_id":["df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff"],"package_ndc":["10742-8160-1","3107420109"],"is_original_packager":[true],"upc":["0310742010916","310742010916"],"unii":["MZ1131787D","FZ989GH94E","6DC9Q167V3"]},"product_type":"Drugs","event_id":"99440","recalling_firm":"Rohto-Mentholatum (Vietnam) Co., Ltd.","address_1":"No. 16 Vsip, Street No. 5","address_2":"Vietnam Singapore Industrial Park","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0718-2026","product_description":"Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1","product_quantity":"1,278,457 cartons","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260714","center_classification_date":"20260723","report_date":"20260729","code_info":"Lot #: 3H1V, 3H1VA, Exp. Date 2025/07; 3J1V, 3J2V, Exp. Date 2025/09;  3K1V, Exp. Date 2025/10; 4F1V, Exp. Date 2027/05; 4F1VA, Exp. Date 2027/05; 4H1V, Exp. Date 2027/07; 4I1V, Exp. Date 2027/08; 4K1V, 4K2V,Exp. Date 2027/10; 5A1V, 5A2V, Exp. Date 2027/12; 5D1V, Exp. Date 2028/03; 5E1V, Exp. Date2028/04; 5J1V, 5J2V, Exp. Date 2028/09; 6B1V, Exp. Date 2029/01; 6C1V, 6C1VA, 6C1VB, Exp. Date 2029/02."},{"status":"Ongoing","city":"Ho Chi Minh","state":"N/A","country":"Vietnam","classification":"Class II","openfda":{"application_number":["M018"],"brand_name":["ROHTO DIGI-EYE"],"generic_name":["HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE"],"manufacturer_name":["The Mentholatum Company"],"product_ndc":["10742-8175"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"substance_name":["HYPROMELLOSE, UNSPECIFIED","TETRAHYDROZOLINE HYDROCHLORIDE"],"rxcui":["1098644"],"spl_id":["5363969d-75c3-8036-e063-6394a90ae420"],"spl_set_id":["5d6f37b9-b568-4cb6-92de-eb40779f3f8c"],"package_ndc":["10742-8175-1","3107420106"],"is_original_packager":[true],"unii":["3NXW29V3WO","0YZT43HS7D"],"upc":["310742010602"]},"product_type":"Drugs","event_id":"99440","recalling_firm":"Rohto-Mentholatum (Vietnam) Co., Ltd.","address_1":"No. 16 Vsip, Street No. 5","address_2":"Vietnam Singapore Industrial Park","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0719-2026","product_description":"Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1","product_quantity":"65219 cartons","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260714","center_classification_date":"20260723","report_date":"20260729","code_info":"Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09"},{"status":"Ongoing","city":"Ho Chi Minh","state":"N/A","country":"Vietnam","classification":"Class II","openfda":{"application_number":["M018"],"brand_name":["ROHTO DRY-AID"],"generic_name":["POVIDONE, PROPYLENE GLYCOL"],"manufacturer_name":["The Mentholatum Company"],"product_ndc":["10742-8162"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"substance_name":["POVIDONE, UNSPECIFIED","PROPYLENE GLYCOL"],"rxcui":["1863574"],"spl_id":["59588453-9990-ef56-e063-6394a90a7e4a"],"spl_set_id":["8ea5c6c9-48f4-406a-a2cb-9280c546d87d"],"package_ndc":["10742-8162-1","10742-8162-2","3107420111"],"is_original_packager":[true],"unii":["FZ989GH94E","6DC9Q167V3"],"upc":["310742011135"]},"product_type":"Drugs","event_id":"99440","recalling_firm":"Rohto-Mentholatum (Vietnam) Co., Ltd.","address_1":"No. 16 Vsip, Street No. 5","address_2":"Vietnam Singapore Industrial Park","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0720-2026","product_description":"Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1","product_quantity":"97201 cartons","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260714","center_classification_date":"20260723","report_date":"20260729","code_info":"Lot #: 4G1VA, Exp. Date 2027/06; 4J1VA, Exp. Date 2027/09;  5A1V, Exp. Date 2027/12;  5D1VA, Exp. Date 2028/03; 5G1VA, Exp. Date 2028/06; 512V, 512V, 512VB Exp. Date 2028/08; 5L2VA, 512VB 2028/11."},{"status":"Ongoing","city":"Ho Chi Minh","state":"N/A","country":"Vietnam","classification":"Class II","openfda":{"application_number":["M018"],"brand_name":["ROHTO DRY-AID"],"generic_name":["POVIDONE, PROPYLENE GLYCOL"],"manufacturer_name":["The Mentholatum Company"],"product_ndc":["10742-8162"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"substance_name":["POVIDONE, UNSPECIFIED","PROPYLENE GLYCOL"],"rxcui":["1863574"],"spl_id":["59588453-9990-ef56-e063-6394a90a7e4a"],"spl_set_id":["8ea5c6c9-48f4-406a-a2cb-9280c546d87d"],"package_ndc":["10742-8162-1","10742-8162-2","3107420111"],"is_original_packager":[true],"unii":["FZ989GH94E","6DC9Q167V3"],"upc":["310742011159"]},"product_type":"Drugs","event_id":"99440","recalling_firm":"Rohto-Mentholatum (Vietnam) Co., Ltd.","address_1":"No. 16 Vsip, Street No. 5","address_2":"Vietnam Singapore Industrial Park","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0721-2026","product_description":"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","product_quantity":"353 cartons","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260714","center_classification_date":"20260723","report_date":"20260729","code_info":"Lot #: 4G1V, Exp 2027/06; 4J1V, 512VB 2027/09; 5D1V, 2028/03; 5G1V, 512VB 2028/06;  512V, 512VB 2028/08"},{"status":"Ongoing","city":"Ho Chi Minh","state":"N/A","country":"Vietnam","classification":"Class II","openfda":{"application_number":["M018"],"brand_name":["ROHTO"],"generic_name":["NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80"],"manufacturer_name":["The Mentholatum Company"],"product_ndc":["10742-8141"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"substance_name":["NAPHAZOLINE HYDROCHLORIDE","POLYSORBATE 80"],"rxcui":["1098362"],"spl_id":["54a037ff-1157-92f5-e063-6294a90a4de0"],"spl_set_id":["dc8f1ff3-87ae-47ca-815f-5a0e34f8cf30"],"package_ndc":["10742-8141-1","3107420107"],"is_original_packager":[true],"upc":["0310742010749","310742010749"],"unii":["MZ1131787D","6OZP39ZG8H"]},"product_type":"Drugs","event_id":"99440","recalling_firm":"Rohto-Mentholatum (Vietnam) Co., Ltd.","address_1":"No. 16 Vsip, Street No. 5","address_2":"Vietnam Singapore Industrial Park","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0722-2026","product_description":"Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1","product_quantity":"2910148 cartons","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260714","center_classification_date":"20260723","report_date":"20260729","code_info":"Lot #: 3J1V, Exp. Date 2026/09; 4A1V, Exp. Date 2026/12;  4G1V, 4G2V, Exp. Date 2027/06; 4I1V, Exp. Date 2027/08; 4JIV, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12 ;  5B1V, Exp. Date 2028/01; 5F1V, Exp. Date 2028/05; 5F1VA, Exp. Date 2028/05; 5H1V & 5H1VA, Exp. Date 2028/07; 5J1V, 5J1VA, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6B1V, Exp. Date 2029/01."}]}}