{"url_path":"/fda/drug/recalls/D-0527-2026","section_key":"summary","section_title":"DRUG Recall: ENDO USA, Inc. — Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-03-13","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0527-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"ENDO USA, Inc."},"word_count":72,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0527-2026\n\n**Recalling firm:** ENDO USA, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-13\n**Report date:** 2026-05-20\n\n## Product\nBuprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.\n\n## Reason\nPresence of particulate matter: identified as Buprenorphine free base\n\n## Affected lots\nLot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027\n\n## Distribution\nUSA Nationwide"}