{"recall":{"id":"fda-drug-99401","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Rising Pharma Holding, Inc. recalls Rising","firm":"Rising Pharma Holding, Inc.","date":"2026-07-13","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.","code":"Lots: Batch # CR2518, Exp. 11/2027; Batch # CR2601, Exp. 12/2027; CR2602, CR2603, Exp. 01/2028; CR2604, CR2605, Exp. 02/2028.","quantity":"74208 units","number":"D-0724-2026","classification":"Class II"}],"reason":"Presence of Precipitate: medication was crystallizing and particles floating in the bottle","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide U.S.A.","nationwide":true,"states":[],"units":"74208 units","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=99401","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f887d5ae65d6150b","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=99401","record":[{"status":"Ongoing","city":"East Brunswick","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA040668"],"brand_name":["CYPROHEPTADINE HYDROCHLORIDE"],"generic_name":["CYPROHEPTADINE HYDROCHLORIDE"],"manufacturer_name":["Rising Pharma Holdings, Inc."],"product_ndc":["64980-504"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["CYPROHEPTADINE HYDROCHLORIDE"],"rxcui":["866021"],"spl_id":["9b4845c1-9b59-4809-9247-50565fc4b6fb"],"spl_set_id":["e2bf4d46-6585-41d9-868c-98603b165d5b"],"package_ndc":["64980-504-48"],"is_original_packager":[true],"upc":["0364980504485"],"unii":["NJ82J0F8QC"]},"product_type":"Drugs","event_id":"99401","recalling_firm":"Rising Pharma Holding, Inc.","address_1":"2 Tower Center Blvd Ste 1401","address_2":"N/A","postal_code":"08816-1149","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide U.S.A.","recall_number":"D-0724-2026","product_description":"Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.","product_quantity":"74208 units","reason_for_recall":"Presence of Precipitate: medication was crystallizing and particles floating in the bottle","recall_initiation_date":"20260713","center_classification_date":"20260723","report_date":"20260729","code_info":"Lots: Batch # CR2518, Exp. 11/2027; Batch # CR2601, Exp. 12/2027; CR2602, CR2603, Exp. 01/2028; CR2604, CR2605, Exp. 02/2028."}]}}