{"recall":{"id":"fda-drug-99481","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"MICRO LABS USA INC recalls Dorzolamide HCl and Timolol Maleate Ophthalmic Solution","firm":"MICRO LABS USA INC","date":"2026-07-22","reported":"2026-08-05","status":"Ongoing","classification":"Class II","products":[{"name":"Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.","code":"Lot # DLHU0031, Exp Date: 06/30/2027.","quantity":"N/A","number":"D-0730-2026","classification":"Class II"}],"reason":"Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide in the USA.","nationwide":true,"states":[],"units":"N/A","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=99481","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"526d994d13288cb5","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=99481","record":[{"status":"Ongoing","city":"Somerset","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA204777"],"brand_name":["DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION"],"generic_name":["DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE"],"manufacturer_name":["Micro Labs Limited"],"product_ndc":["42571-147"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["OPHTHALMIC"],"substance_name":["DORZOLAMIDE HYDROCHLORIDE","TIMOLOL MALEATE"],"rxcui":["1923432"],"spl_id":["22ff7483-50ec-42c6-e063-6394a90ae1fa"],"spl_set_id":["f45cce05-fb47-4607-b68e-5a3d47e7235a"],"package_ndc":["42571-147-26"],"is_original_packager":[true],"upc":["0342571147266"],"unii":["QZO5366EW7","P8Y54F701R"]},"product_type":"Drugs","event_id":"99481","recalling_firm":"MICRO LABS USA INC","address_1":"220 Davidson Ave","address_2":"N/A","postal_code":"08873-4149","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the USA.","recall_number":"D-0730-2026","product_description":"Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.","product_quantity":"N/A","reason_for_recall":"Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.","recall_initiation_date":"20260722","center_classification_date":"20260724","report_date":"20260805","code_info":"Lot # DLHU0031, Exp Date: 06/30/2027."}]}}