{"url_path":"/fda/drug/recalls/D-0515-2026","section_key":"summary","section_title":"DRUG Recall: Ajanta Pharma Ltd. — Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-29","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0515-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Ajanta Pharma Ltd."},"word_count":86,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0515-2026\n\n**Recalling firm:** Ajanta Pharma Ltd.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-29\n**Report date:** 2026-05-13\n\n## Product\nDuloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03\n\n## Reason\nCGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.\n\n## Affected lots\nLot#: PA07434, Exp. May 2026.\n\n## Distribution\nNationwide within U.S"}