{"url_path":"/fda/drug/recalls/D-0493-2026","section_key":"summary","section_title":"DRUG Recall: The Harvard Drug Group LLC — Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288.  NDC: 0904-7495-06","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-09","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0493-2026%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":98,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0493-2026\n\n**Recalling firm:** The Harvard Drug Group LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-09\n**Report date:** 2026-04-29\n\n## Product\nOmega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288.  NDC: 0904-7495-06\n\n## Reason\nFailed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.\n\n## Affected lots\nLot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026\n\n## Distribution\nNationwide in the USA"}