{"recall":{"id":"fda-drug-99978","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Apotex Corp. recalls Paroxetine Extended-Release Tablets","firm":"Apotex Corp.","date":"2026-09-23","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"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 60505-1318-3","code":"Lot# TY9495, Exp Date: 05/2027.","quantity":"","number":"D-0877-2026","classification":"Class II"}],"reason":"Failed dissolution specifications.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"","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=99978","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"6a4dfad4a4c4ff97","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=99978","record":[{"status":"Ongoing","city":"Weston","state":"FL","country":"United States","classification":"Class II","openfda":{"application_number":["NDA020936"],"brand_name":["PAROXETINE HYDROCHLORIDE"],"generic_name":["PAROXETINE HYDROCHLORIDE"],"manufacturer_name":["Apotex Corp"],"product_ndc":["60505-1316","60505-1317","60505-1318","60505-3673","60505-3674","60505-3675"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["PAROXETINE HYDROCHLORIDE"],"rxcui":["1738803","1738805","1738807"],"spl_id":["f66c4702-5904-afb1-5a22-a236e8fa7f25"],"spl_set_id":["087ff0d3-1761-47ea-a8c1-7c4cb679af97"],"package_ndc":["60505-1316-3","60505-1317-3","60505-1318-3","60505-3673-3","60505-3674-3","60505-3675-3"],"is_original_packager":[true],"upc":["0360505367436","0360505367535","0360505367337"],"unii":["X2ELS050D8"]},"product_type":"Drugs","event_id":"99978","recalling_firm":"Apotex Corp.","address_1":"2400 N Commerce Pkwy Ste 400","address_2":"","postal_code":"33326-3253","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0877-2026","product_description":"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 60505-1318-3","product_quantity":"","reason_for_recall":"Failed dissolution specifications.","recall_initiation_date":"20260923","center_classification_date":"20260929","report_date":"20261007","code_info":"Lot# TY9495, Exp Date: 05/2027.","more_code_info":""}]}}