{"url_path":"/fda/drug/recalls/D-0494-2026","section_key":"summary","section_title":"DRUG Recall: American Regent, Inc. — Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967.  NDC: 0517-1045-01","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-16","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0494-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"American Regent, Inc."},"word_count":75,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0494-2026\n\n**Recalling firm:** American Regent, Inc.\n**Classification:** Class III\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-16\n**Report date:** 2026-05-06\n\n## Product\nLevocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967.  NDC: 0517-1045-01\n\n## Reason\nLabeling: Missing Label\n\n## Affected lots\nLot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31,  2027\n\n## Distribution\nU.S. Nationwide"}