{"url_path":"/fda/drug/recalls/D-0599-2026","section_key":"summary","section_title":"DRUG Recall: SUN PHARMACEUTICAL INDUSTRIES INC — Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-05-22","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0599-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"SUN PHARMACEUTICAL INDUSTRIES INC"},"word_count":101,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0599-2026\n\n**Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-22\n**Report date:** 2026-06-10\n\n## Product\nXyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10\n\n## Reason\nLabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona\n\n## Affected lots\nLot #: AE11393, Exp Date: 10/2027.\n\n## Distribution\nNationwide within the United States"}