{"url_path":"/fda/drug/recalls/D-0543-2026","section_key":"summary","section_title":"DRUG Recall: ANI Pharmaceuticals, Inc. — Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.  NDC 70954-531-20","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-05-12","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0543-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"ANI Pharmaceuticals, Inc."},"word_count":79,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0543-2026\n\n**Recalling firm:** ANI Pharmaceuticals, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-12\n**Report date:** 2026-05-27\n\n## Product\nEstradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.  NDC 70954-531-20\n\n## Reason\nDefective Container; packets were found to be either empty or partially full.\n\n## Affected lots\nLot M251109, exp Nov 2027\n\n## Distribution\nNationwide in the USA"}