{"url_path":"/fda/drug/recalls/D-0735-2026","section_key":"summary","section_title":"DRUG Recall: Ascend Laboratories, LLC — Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-06-30","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0735-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Ascend Laboratories, LLC"},"word_count":93,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0735-2026\n\n**Recalling firm:** Ascend Laboratories, LLC\n**Classification:** Class III\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-30\n**Report date:** 2026-07-29\n\n## Product\nDabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.\n\n## Reason\nFailed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.\n\n## Affected lots\nLot: 25141707, Exp 4/30/2027.\n\n## Distribution\nUSA Nationwide"}