{"recall":{"id":"fda-drug-99795","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"TerSera Therapeutics LLC recalls Zoladex (goserelin) implant","firm":"TerSera Therapeutics LLC","date":"2026-08-31","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Switzerland, website at www.zoladex.com, NDC 70720-950-36.","code":"Lot#: YN0099, Exp 01/31/2028","quantity":"296 cartons","number":"D-0875-2026","classification":"Class II"}],"reason":"Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"USA Nationwide","nationwide":true,"states":[],"units":"296 cartons","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=99795","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c8cdf916882612c9","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=99795","record":[{"status":"Ongoing","city":"Deerfield","state":"IL","country":"United States","classification":"Class II","openfda":{"application_number":["NDA019726"],"brand_name":["ZOLADEX"],"generic_name":["GOSERELIN"],"manufacturer_name":["TerSera Therapeutics LLC"],"product_ndc":["70720-950"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["SUBCUTANEOUS"],"substance_name":["GOSERELIN ACETATE"],"rxcui":["105641","310592"],"spl_id":["c48edbf8-425f-4e11-8892-467e868d9fba"],"spl_set_id":["294b168b-6e5f-4db9-bf70-d599271458b3"],"package_ndc":["70720-950-36"],"is_original_packager":[true],"unii":["6YUU2PV0U8"]},"product_type":"Drugs","event_id":"99795","recalling_firm":"TerSera Therapeutics LLC","address_1":"520 Lake Cook Rd Ste 500","address_2":"","postal_code":"60015-5633","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"USA Nationwide","recall_number":"D-0875-2026","product_description":"Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Switzerland, website at www.zoladex.com, NDC 70720-950-36.","product_quantity":"296 cartons","reason_for_recall":"Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.","recall_initiation_date":"20260831","center_classification_date":"20260928","report_date":"20261007","code_info":"Lot#: YN0099, Exp 01/31/2028","more_code_info":""}]}}