{"url_path":"/fda/drug/recalls/D-0804-2026","section_key":"summary","section_title":"DRUG Recall: Apotex Corp. — 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","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-08-13","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0804-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Apotex Corp."},"word_count":81,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0804-2026\n\n**Recalling firm:** Apotex Corp.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-08-13\n**Report date:** 2026-09-02\n\n## Product\nPaxil 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\n\n## Reason\nFailed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria\n\n## Affected lots\nLot # TY9494, Exp Date: 05/31/2027.\n\n## Distribution\nUS Nationwide."}