{"topic":"fda","display_name":"FDA Enforcement","description":"US Food and Drug Administration enforcement data: drug/device/food recalls (including Class I most-serious), FAERS adverse-event reports, 510(k) medical device clearances, and Structured Product Labeling (drug labels with indications, warnings, dosage).","counts":{"recalls":200,"adverse_events":50,"clearances_510k":50,"drug_labels":100},"recent":{"recent_recalls":[{"recall_number":"D-0501-2026","recalling_firm":"Thea Pharma, Inc.","product_type":"drug","classification":"Class II","reason":"Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.","recall_initiation_date":"2026-04-23"},{"recall_number":"D-0500-2026","recalling_firm":"Thea Pharma, Inc.","product_type":"drug","classification":"Class II","reason":"Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.","recall_initiation_date":"2026-04-23"},{"recall_number":"H-0685-2026","recalling_firm":"King Juice Company, Inc.","product_type":"food","classification":"Class II","reason":"Product contains undeclared Yellow No. 5.","recall_initiation_date":"2026-04-23"},{"recall_number":"D-0492-2026","recalling_firm":"Alcon Research LLC","product_type":"drug","classification":"Class II","reason":"Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.","recall_initiation_date":"2026-04-21"},{"recall_number":"D-0491-2026","recalling_firm":"Alcon Research LLC","product_type":"drug","classification":"Class II","reason":"Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.","recall_initiation_date":"2026-04-21"},{"recall_number":"D-0499-2026","recalling_firm":"SCOPE HEALTH","product_type":"drug","classification":"Class II","reason":"Lack of Assurance of Sterility","recall_initiation_date":"2026-04-20"},{"recall_number":"H-0684-2026","recalling_firm":"The Mochi Ice Cream Company, LLC","product_type":"food","classification":"Class II","reason":"Foreign object found inside retail container.","recall_initiation_date":"2026-04-20"},{"recall_number":"D-0489-2026","recalling_firm":"Harrow Eye LLC","product_type":"drug","classification":"Class II","reason":"Lack of Assurance of Sterility","recall_initiation_date":"2026-04-17"}],"serious_adverse_events":[{"safetyreportid":"26555299","receivedate":"2026-03-31","seriousness_death":0,"seriousness_hospitalization":1,"drugs":"[{\"name\":\"COSENTYX\",\"brand\":\"COSENTYX\",\"generic\":\"SECUKINUMAB\",\"substance\":\"SECUKINUMAB\",\"indication\":\"Psoriatic arthropathy\"},{\"name\":\"COSENTYX\",\"bra","reactions":"[\"Pneumonia\"]"},{"safetyreportid":"26555302","receivedate":"2026-03-31","seriousness_death":0,"seriousness_hospitalization":1,"drugs":"[{\"name\":\"IMURAN\",\"brand\":\"IMURAN\",\"generic\":\"AZATHIOPRINE\",\"substance\":\"AZATHIOPRINE\",\"indication\":\"Product used for unknown indication\"},{\"name\":\"LU","reactions":"[\"Vision blurred\",\"Swelling\",\"Arthralgia\",\"Systemic lupus erythematosus\",\"Blood creatinine increased\",\"Blood pressure increased\",\"Fluid retention\",\"Dy"},{"safetyreportid":"26555304","receivedate":"2026-03-31","seriousness_death":0,"seriousness_hospitalization":1,"drugs":"[{\"name\":\"IBUPROFEN\",\"brand\":\"IBUPROFEN\",\"generic\":\"IBUPROFEN\",\"substance\":\"IBUPROFEN\",\"indication\":\"Product used for unknown indication\"},{\"name\":\"QU","reactions":"[\"Suspected suicide attempt\",\"Poisoning deliberate\"]"},{"safetyreportid":"26555311","receivedate":"2026-03-31","seriousness_death":1,"seriousness_hospitalization":0,"drugs":"[{\"name\":\"ARANESP\",\"brand\":\"ARANESP\",\"generic\":\"DARBEPOETIN ALFA\",\"substance\":\"DARBEPOETIN ALFA\",\"indication\":\"End stage renal disease\"}]","reactions":"[\"Death\"]"},{"safetyreportid":"26555314","receivedate":"2026-03-31","seriousness_death":0,"seriousness_hospitalization":1,"drugs":"[{\"name\":\"HUMIRA\",\"brand\":\"HUMIRA\",\"generic\":\"ADALIMUMAB\",\"indication\":\"Crohn^s disease\"}]","reactions":"[\"Stoma creation\",\"Drug specific antibody present\",\"Stoma closure\"]"}],"recent_510k_clearances":[{"k_number":"K261074","applicant":"Biotronik, Inc.","device_name":"BIOMONITOR IV (471155)","decision_date":"2026-05-01","decision":"Substantially Equivalent"},{"k_number":"K253326","applicant":"Fziomed, Inc.","device_name":"Oxiplex","decision_date":"2026-05-01","decision":"Substantially Equivalent"},{"k_number":"K253966","applicant":"Spineart SA","device_name":"PERLA® TL Posterior Thoraco-lumbar Fixation System","decision_date":"2026-05-01","decision":"Substantially Equivalent"},{"k_number":"K260314","applicant":"Aspero Medical, Inc.","device_name":"Ancora-SB","decision_date":"2026-05-01","decision":"Substantially Equivalent"},{"k_number":"K252475","applicant":"Radiometer Medicals Aps","device_name":"ABL90 FLEX PLUS System","decision_date":"2026-05-01","decision":"Substantially Equivalent"}]},"endpoints":{"recent_recalls":"/api/v1/fda/recalls/recent","recent_adverse":"/api/v1/fda/adverse-events/recent","recent_510k":"/api/v1/fda/510k/recent","recent_labels":"/api/v1/fda/labels/recent","label_lookup":"/api/v1/fda/labels/{name}","firm_dossier":"/api/v1/fda/firms/{name}","stats":"/api/v1/fda/stats"}}