{"recall":{"id":"fda-drug-99437","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Sunny Pharmtech Inc. recalls 2 products","firm":"Sunny Pharmtech Inc.","date":"2026-07-17","reported":"2026-08-12","status":"Ongoing","classification":"Class I","products":[{"name":"Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1","code":"Lot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027","quantity":"4,077 vials","number":"D-0743-2026","classification":"Class I"},{"name":"Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1","code":"Lot # V24010V1, Exp 3/31/2027","quantity":"1,464 vials","number":"D-0744-2026","classification":"Class I"}],"reason":"Presence of Particulate Matter; identified as stainless steel","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"USA Nationwide","nationwide":true,"states":[],"units":"4,077 vials; 1,464 vials","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=99437","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"9c3eb471bcd63ee2","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=99437","record":[{"status":"Ongoing","city":"Taoyuan City","state":"","country":"Taiwan","classification":"Class I","openfda":{},"product_type":"Drugs","event_id":"99437","recalling_firm":"Sunny Pharmtech Inc.","address_1":"Hsinchu Science Park","address_2":"No. 255 Longyuan 1st Rd.; Longtan Dist.","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"USA Nationwide","recall_number":"D-0743-2026","product_description":"Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018.  Manufactured in Taiwan, NDC 81298-8112-1","product_quantity":"4,077 vials","reason_for_recall":"Presence of Particulate Matter; identified as stainless steel","recall_initiation_date":"20260717","center_classification_date":"20260807","report_date":"20260812","code_info":"Lot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027","more_code_info":""},{"status":"Ongoing","city":"Taoyuan City","state":"","country":"Taiwan","classification":"Class I","openfda":{},"product_type":"Drugs","event_id":"99437","recalling_firm":"Sunny Pharmtech Inc.","address_1":"Hsinchu Science Park","address_2":"No. 255 Longyuan 1st Rd.; Longtan Dist.","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"USA Nationwide","recall_number":"D-0744-2026","product_description":"Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018.  Manufactured in Taiwan, NDC 81298-8114-1","product_quantity":"1,464 vials","reason_for_recall":"Presence of Particulate Matter; identified as stainless steel","recall_initiation_date":"20260717","center_classification_date":"20260807","report_date":"20260812","code_info":"Lot # V24010V1, Exp 3/31/2027","more_code_info":""}]}}