{"recall":{"id":"fda-drug-99283","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Padagis US LLC recalls Nystatin Cream USP","firm":"Padagis US LLC","date":"2026-06-23","reported":"2026-07-22","status":"Ongoing","classification":"Class II","products":[{"name":"Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35","code":"Lot #: 205060, Exp 09/30/2027","quantity":"180,936 tubes","number":"D-0677-2026","classification":"Class II"}],"reason":"Subpotent Drug: Low out of specification assay results performed during long-term stability testing.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"USA Nationwide","nationwide":true,"states":[],"units":"180,936 tubes","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=99283","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"ed262bc242b7efb1","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=99283","record":[{"status":"Ongoing","city":"Minneapolis","state":"MN","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA062225"],"brand_name":["NYSTATIN"],"generic_name":["NYSTATIN"],"manufacturer_name":["Padagis Israel Pharmaceuticals Ltd"],"product_ndc":["45802-059"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"substance_name":["NYSTATIN"],"rxcui":["543546"],"spl_id":["e2839c50-5b8f-4e7b-9636-d22687038a89"],"spl_set_id":["e630aa3d-11a6-4300-942a-cbdf2d016f77"],"package_ndc":["45802-059-35","45802-059-11"],"is_original_packager":[true],"nui":["N0000175498","M0017172"],"pharm_class_epc":["Polyene Antifungal [EPC]"],"pharm_class_cs":["Polyenes [CS]"],"unii":["BDF1O1C72E"]},"product_type":"Drugs","event_id":"99283","recalling_firm":"Padagis US LLC","address_1":"3940 Quebec Ave N","address_2":"","postal_code":"55427-1244","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"USA Nationwide","recall_number":"D-0677-2026","product_description":"Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35","product_quantity":"180,936 tubes","reason_for_recall":"Subpotent Drug: Low out of specification assay results performed during long-term stability testing.","recall_initiation_date":"20260623","center_classification_date":"20260713","report_date":"20260722","code_info":"Lot #: 205060, Exp 09/30/2027","more_code_info":""}]}}