{"recall":{"id":"fda-drug-99734","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Teva Pharmaceuticals USA, Inc recalls traZODone Hydrochloride Tablets","firm":"Teva Pharmaceuticals USA, Inc","date":"2026-08-24","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01","code":"Lot: 1394026, Exp. 02/2028.","quantity":"175,392 bottles","number":"D-0834-2026","classification":"Class II"}],"reason":"Presence of Foreign Tablets/Capsules","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide","nationwide":true,"states":[],"units":"175,392 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=99734","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"a6f7f538b6a701d1","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=99734","record":[{"status":"Ongoing","city":"Parsippany","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA071525"],"brand_name":["TRAZODONE HYDROCHLORIDE"],"generic_name":["TRAZODONE HYDROCHLORIDE"],"manufacturer_name":["Teva Pharmaceuticals USA, Inc."],"product_ndc":["50111-450","50111-560","50111-561"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["TRAZODONE HYDROCHLORIDE"],"rxcui":["856364","856373","856377"],"spl_id":["3313a8d0-eb39-47a4-b476-0973aad30e02"],"spl_set_id":["4006d439-e2de-4590-82e9-fc9d56e3ec1b"],"package_ndc":["50111-560-01","50111-560-02","50111-560-03","50111-561-01","50111-561-02","50111-561-03","50111-450-01","50111-450-02"],"is_original_packager":[true],"upc":["0350111450011"],"unii":["6E8ZO8LRNM"]},"product_type":"Drugs","event_id":"99734","recalling_firm":"Teva Pharmaceuticals USA, Inc","address_1":"400 Interpace Pkwy Bldg A","address_2":"N/A","postal_code":"07054-1120","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide","recall_number":"D-0834-2026","product_description":"traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01","product_quantity":"175,392 bottles","reason_for_recall":"Presence of Foreign Tablets/Capsules","recall_initiation_date":"20260824","center_classification_date":"20260908","report_date":"20260909","code_info":"Lot: 1394026, Exp. 02/2028.","more_code_info":""}]}}