{"recall":{"id":"fda-drug-99673","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Apotex Corp. recalls Paxil CR","firm":"Apotex Corp.","date":"2026-08-13","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3","code":"Lot # TY9494, Exp Date: 05/31/2027.","quantity":"6,972 bottles","number":"D-0804-2026","classification":"Class II"}],"reason":"Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"6,972 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=99673","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f2da782146bd756a","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=99673","record":[{"status":"Ongoing","city":"Weston","state":"FL","country":"United States","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99673","recalling_firm":"Apotex Corp.","address_1":"2400 N Commerce Pkwy Ste 400","address_2":"N/A","postal_code":"33326-3253","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0804-2026","product_description":"Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3","product_quantity":"6,972 bottles","reason_for_recall":"Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria","recall_initiation_date":"20260813","center_classification_date":"20260827","report_date":"20260902","code_info":"Lot # TY9494, Exp Date: 05/31/2027."}]}}