{"url_path":"/fda/drug/recalls/D-0803-2026","section_key":"summary","section_title":"DRUG Recall: Mallinckrodt Hospital Products Inc. — Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-08-06","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0803-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Mallinckrodt Hospital Products Inc."},"word_count":81,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0803-2026\n\n**Recalling firm:** Mallinckrodt Hospital Products Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-08-06\n**Report date:** 2026-09-02\n\n## Product\nActhar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2\n\n## Reason\nPresence of particulate matter: glass and stopper piece\n\n## Affected lots\nLot#:  NDC 63004-8710-1 - 1564-107, exp 1/31/2027  NDC 63004-8710-2 - 1564-107H, exp 1/31/2027\n\n## Distribution\nUSA Nationwide"}