{"recall":{"id":"fda-drug-99762","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Amneal Pharmaceuticals of New York, LLC recalls Exenatide Injection","firm":"Amneal Pharmaceuticals of New York, LLC","date":"2026-08-28","reported":"2026-09-30","status":"Ongoing","classification":"Class II","products":[{"name":"Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1","code":"Lot #: AP250095A, Exp 2/28/2027","quantity":"5,694 pens","number":"D-0868-2026","classification":"Class II"}],"reason":"Defective Delivery System: Possibility of no medication in the prefilled pen.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"USA Nationwide","nationwide":true,"states":[],"units":"5,694 pens","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=99762","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"387918c4254004dc","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=99762","record":[{"status":"Ongoing","city":"Brookhaven","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA206697"],"brand_name":["EXENATIDE"],"generic_name":["EXENATIDE"],"manufacturer_name":["Amneal Pharmaceuticals LLC"],"product_ndc":["70121-1685","70121-1686"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["SUBCUTANEOUS"],"substance_name":["EXENATIDE"],"rxcui":["847910","847915"],"spl_id":["2141c3ca-074a-4098-85da-1ef78ec4d4dc"],"spl_set_id":["e6cb5c8f-e97f-4a6a-95a4-939fd2393949"],"package_ndc":["70121-1685-1","70121-1686-1"],"is_original_packager":[true],"nui":["N0000178480","M0160181","N0000020058"],"pharm_class_epc":["GLP-1 Receptor Agonist [EPC]"],"pharm_class_cs":["Glucagon-Like Peptide 1 [CS]"],"pharm_class_moa":["Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]"],"unii":["9P1872D4OL"]},"product_type":"Drugs","event_id":"99762","recalling_firm":"Amneal Pharmaceuticals of New York, LLC","address_1":"50 Horseblock Rd","address_2":"","postal_code":"11719-9509","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"USA Nationwide","recall_number":"D-0868-2026","product_description":"Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1","product_quantity":"5,694 pens","reason_for_recall":"Defective Delivery System: Possibility of no medication in the prefilled pen.","recall_initiation_date":"20260828","center_classification_date":"20260922","report_date":"20260930","code_info":"Lot #: AP250095A, Exp 2/28/2027","more_code_info":""}]}}