{"recall":{"id":"fda-drug-100017","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Zydus Pharmaceuticals (USA) Inc recalls Hydrocortisone Sodium Succinate for Injection","firm":"Zydus Pharmaceuticals (USA) Inc","date":"2026-10-01","reported":"2026-10-21","status":"Ongoing","classification":"Class II","products":[{"name":"Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1.","code":"Lot #: LB00047A, LB00048A, Exp. Date 03/2028","quantity":"70776 vials","number":"D-0039-2027","classification":"Class II"}],"reason":"Failed Impurities/Degradation Specifications.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide within the United States","nationwide":true,"states":[],"units":"70776 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=100017","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"62e97688d560c14a","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=100017","record":[{"status":"Ongoing","city":"Pennington","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA217191"],"brand_name":["HYDROCORTISONE SODIUM SUCCINATE"],"generic_name":["HYDROCORTISONE SODIUM SUCCINATE"],"manufacturer_name":["Zydus Pharmaceuticals USA Inc."],"product_ndc":["70710-1907"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAMUSCULAR","INTRAVENOUS"],"substance_name":["HYDROCORTISONE SODIUM SUCCINATE"],"rxcui":["238755"],"spl_id":["9e47e808-7310-4c61-ac62-595a5c357123"],"spl_set_id":["37534164-9de5-4bb3-9f87-341dfcf90883"],"package_ndc":["70710-1907-1"],"is_original_packager":[true],"unii":["50LQB69S1Z"]},"product_type":"Drugs","event_id":"100017","recalling_firm":"Zydus Pharmaceuticals (USA) Inc","address_1":"73 Route 31 N","address_2":"","postal_code":"08534-3601","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0039-2027","product_description":"Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1.","product_quantity":"70776 vials","reason_for_recall":"Failed Impurities/Degradation Specifications.","recall_initiation_date":"20261001","center_classification_date":"20261013","report_date":"20261021","code_info":"Lot #: LB00047A, LB00048A, Exp. Date 03/2028","more_code_info":""}]}}