{"url_path":"/fda/drug/recalls/D-0511-2026","section_key":"summary","section_title":"DRUG Recall: Unichem Pharmaceuticals USA Inc. — busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-13","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0511-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Unichem Pharmaceuticals USA Inc."},"word_count":78,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0511-2026\n\n**Recalling firm:** Unichem Pharmaceuticals USA Inc.\n**Classification:** Class III\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-13\n**Report date:** 2026-05-13\n\n## Product\nbusPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.\n\n## Reason\nSubpotent drug\n\n## Affected lots\nLot: ZBUL25001, Exp 12/31/2027\n\n## Distribution\nUSA Nationwide"}