{"url_path":"/fda/drug/recalls/D-0449-2026","section_key":"summary","section_title":"DRUG Recall: Cipla USA, Inc. — Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.  NDC:  69097-410-02","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-03-16","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0449-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Cipla USA, Inc."},"word_count":93,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0449-2026\n\n**Recalling firm:** Cipla USA, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-16\n**Report date:** 2026-04-22\n\n## Product\nCinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.  NDC:  69097-410-02\n\n## Reason\nCGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit\n\n## Affected lots\nLot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027\n\n## Distribution\nNationwide in the USA"}