{"recall":{"id":"fda-drug-99350","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Cipla USA, Inc. recalls 3 products","firm":"Cipla USA, Inc.","date":"2026-06-29","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"Cinacalcet Hydrochloride Tablets, 30 mg, 30-count 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","code":"Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027","quantity":"31,824 bottles","number":"D-0661-2026","classification":"Class II"},{"name":"Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-411-02","code":"Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027","quantity":"N/A","number":"D-0675-2026","classification":"Class II"},{"name":"Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-412-02","code":"Lot #: 5PB0563, Exp 4/30/2027","quantity":"N/A","number":"D-0676-2026","classification":"Class II"}],"reason":"cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"USA Nationwide","nationwide":true,"states":[],"units":"31,824 bottles; N/A; N/A","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99350","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"a1a9b938fb6c7e7c","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99350","record":[{"status":"Ongoing","city":"Warren","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA208915"],"brand_name":["CINACALCET"],"generic_name":["CINACALCET"],"manufacturer_name":["Cipla USA Inc."],"product_ndc":["69097-410","69097-411","69097-412"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["CINACALCET HYDROCHLORIDE"],"rxcui":["432400","432401","432402"],"spl_id":["383a7dc8-b195-4868-8774-f16a5558771e"],"spl_set_id":["02b8c11b-99e8-4039-b6fa-a9c38d2f48fa"],"package_ndc":["69097-410-02","69097-411-02","69097-412-02"],"is_original_packager":[true],"unii":["1K860WSG25"]},"product_type":"Drugs","event_id":"99350","recalling_firm":"Cipla USA, Inc.","address_1":"10 Independence Blvd","address_2":"N/A","postal_code":"07059-2730","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"USA Nationwide","recall_number":"D-0661-2026","product_description":"Cinacalcet Hydrochloride Tablets, 30 mg, 30-count 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","product_quantity":"31,824 bottles","reason_for_recall":"cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).","recall_initiation_date":"20260629","center_classification_date":"20260709","report_date":"20260708","code_info":"Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027"},{"status":"Ongoing","city":"Warren","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA208915"],"brand_name":["CINACALCET"],"generic_name":["CINACALCET"],"manufacturer_name":["Cipla USA Inc."],"product_ndc":["69097-410","69097-411","69097-412"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["CINACALCET HYDROCHLORIDE"],"rxcui":["432400","432401","432402"],"spl_id":["383a7dc8-b195-4868-8774-f16a5558771e"],"spl_set_id":["02b8c11b-99e8-4039-b6fa-a9c38d2f48fa"],"package_ndc":["69097-410-02","69097-411-02","69097-412-02"],"is_original_packager":[true],"unii":["1K860WSG25"]},"product_type":"Drugs","event_id":"99350","recalling_firm":"Cipla USA, Inc.","address_1":"10 Independence Blvd","address_2":"N/A","postal_code":"07059-2730","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"USA Nationwide","recall_number":"D-0675-2026","product_description":"Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-411-02","product_quantity":"N/A","reason_for_recall":"cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).","recall_initiation_date":"20260629","center_classification_date":"20260709","report_date":"20260708","code_info":"Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027"},{"status":"Ongoing","city":"Warren","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA208915"],"brand_name":["CINACALCET"],"generic_name":["CINACALCET"],"manufacturer_name":["Cipla USA Inc."],"product_ndc":["69097-410","69097-411","69097-412"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["CINACALCET HYDROCHLORIDE"],"rxcui":["432400","432401","432402"],"spl_id":["383a7dc8-b195-4868-8774-f16a5558771e"],"spl_set_id":["02b8c11b-99e8-4039-b6fa-a9c38d2f48fa"],"package_ndc":["69097-410-02","69097-411-02","69097-412-02"],"is_original_packager":[true],"unii":["1K860WSG25"]},"product_type":"Drugs","event_id":"99350","recalling_firm":"Cipla USA, Inc.","address_1":"10 Independence Blvd","address_2":"N/A","postal_code":"07059-2730","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"USA Nationwide","recall_number":"D-0676-2026","product_description":"Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-412-02","product_quantity":"N/A","reason_for_recall":"cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).","recall_initiation_date":"20260629","center_classification_date":"20260709","report_date":"20260708","code_info":"Lot #: 5PB0563, Exp 4/30/2027"}]}}