{"recall":{"id":"fda-drug-99742","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Amneal Pharmaceuticals, LLC recalls Estradiol Gel","firm":"Amneal Pharmaceuticals, LLC","date":"2026-09-08","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.","code":"Lot # 245226005B, Exp Date: 04/30/2028.","quantity":"2,592 30-count cartons","number":"D-0873-2026","classification":"Class II"}],"reason":"Defective Container; packets were found to be either empty or partially full.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide in the USA.","nationwide":true,"states":[],"units":"2,592 30-count 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=99742","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"649a9035eb6c80d3","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=99742","record":[{"status":"Ongoing","city":"Bridgewater","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA216055"],"brand_name":["ESTRADIOL"],"generic_name":["ESTRADIOL TRANSDERMAL"],"manufacturer_name":["Amneal Pharmaceuticals NY LLC"],"product_ndc":["69238-2448","69238-2452","69238-2451","69238-2450","69238-2449"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"substance_name":["ESTRADIOL"],"rxcui":["2619677","2619679","2619681","2619683","2619685"],"spl_id":["cebb61d3-34b7-44a7-aae7-d23e21651713"],"spl_set_id":["9669a0e3-27e2-4f6c-961c-7a67e9f84cc8"],"package_ndc":["69238-2452-1","69238-2452-3","69238-2451-1","69238-2451-3","69238-2450-1","69238-2450-3","69238-2449-1","69238-2449-3","69238-2448-1","69238-2448-3"],"is_original_packager":[true],"nui":["M0447348","N0000175825","N0000000100"],"pharm_class_cs":["Estradiol Congeners [CS]"],"pharm_class_epc":["Estrogen [EPC]"],"pharm_class_moa":["Estrogen Receptor Agonists [MoA]"],"unii":["4TI98Z838E"]},"product_type":"Drugs","event_id":"99742","recalling_firm":"Amneal Pharmaceuticals, LLC","address_1":"400 Crossing Blvd Fl 3","address_2":"","postal_code":"08807-2863","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the USA.","recall_number":"D-0873-2026","product_description":"Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.","product_quantity":"2,592 30-count cartons","reason_for_recall":"Defective Container; packets were found to be either empty or partially full.","recall_initiation_date":"20260908","center_classification_date":"20260928","report_date":"20261007","code_info":"Lot # 245226005B, Exp Date: 04/30/2028.","more_code_info":""}]}}