{"url_path":"/fda/drug/recalls/D-0839-2026","section_key":"summary","section_title":"DRUG Recall: Mylan Pharmaceuticals Inc — Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-08-17","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0839-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Mylan Pharmaceuticals Inc"},"word_count":80,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0839-2026\n\n**Recalling firm:** Mylan Pharmaceuticals Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-08-17\n**Report date:** 2026-09-09\n\n## Product\nPrasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.\n\n## Reason\nFailed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria\n\n## Affected lots\nLot #: 3225272, Exp. September 30, 2026\n\n## Distribution\nNationwide within the U.S"}