{"url_path":"/fda/drug/recalls/D-0533-2026","section_key":"summary","section_title":"DRUG Recall: Lannett Company Inc. — Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-24","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0533-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Lannett Company Inc."},"word_count":84,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0533-2026\n\n**Recalling firm:** Lannett Company Inc.\n**Classification:** Class III\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-24\n**Report date:** 2026-05-27\n\n## Product\nPrimidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.\n\n## Reason\nCross contamination with other products: API contaminated with trace amounts of Acemetacin API.\n\n## Affected lots\nLot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.\n\n## Distribution\nUSA Nationwide"}