{"recall":{"id":"fda-drug-99110","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"SUN PHARMACEUTICAL INDUSTRIES INC recalls Fexofenadine Hydrochloride Tablets","firm":"SUN PHARMACEUTICAL INDUSTRIES INC","date":"2026-06-01","reported":"2026-07-08","status":"Ongoing","classification":"Class III","products":[{"name":"Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30","code":"Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026","quantity":"9,048 bottles","number":"D-0654-2026","classification":"Class III"}],"reason":"Failed Impurities/Degradation Specifications","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"U.S. Nationwide","nationwide":true,"states":[],"units":"9,048 bottles","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=99110","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"b831a7ce13eee87f","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=99110","record":[{"status":"Ongoing","city":"Princeton","state":"NJ","country":"United States","classification":"Class III","openfda":{},"product_type":"Drugs","event_id":"99110","recalling_firm":"SUN PHARMACEUTICAL INDUSTRIES INC","address_1":"2 Independence Way","address_2":"N/A","postal_code":"08540-6620","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide","recall_number":"D-0654-2026","product_description":"Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30","product_quantity":"9,048 bottles","reason_for_recall":"Failed Impurities/Degradation Specifications","recall_initiation_date":"20260601","center_classification_date":"20260630","report_date":"20260708","code_info":"Lot, expiry:  Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026"}]}}