{"url_path":"/fda/drug/recalls/D-0522-2026","section_key":"summary","section_title":"DRUG Recall: Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count  bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-21","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0522-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Breckenridge Pharmaceutical, Inc."},"word_count":81,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0522-2026\n\n**Recalling firm:** Breckenridge Pharmaceutical, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-21\n**Report date:** 2026-05-13\n\n## Product\nDuloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count  bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.\n\n## Reason\nCGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit\n\n## Affected lots\nLot: 241069C, Exp 05/31/2027\n\n## Distribution\nNationwide in the USA"}