{"url_path":"/fda/drug/recalls/D-0485-2026","section_key":"summary","section_title":"DRUG Recall: The Harvard Drug Group LLC — Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC  0904-6734-61","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-03-24","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0485-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"The Harvard Drug Group LLC"},"word_count":72,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0485-2026\n\n**Recalling firm:** The Harvard Drug Group LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-24\n**Report date:** 2026-04-22\n\n## Product\nMemantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC  0904-6734-61\n\n## Reason\nFailed Dissolution Specifications\n\n## Affected lots\nLot # N02425, Exp Date: 05/31/2027.\n\n## Distribution\nUS Nationwide."}