{"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":69372,"adverse_events":180400,"clearances_510k":1018,"drug_labels":51619},"recent":{"recent_recalls":[{"recall_number":"D-0833-2026","recalling_firm":"Supernus Pharmaceuticals, Inc.","product_type":"drug","classification":"Class III","reason":"Failed dissolution specifications.","recall_initiation_date":"2026-08-31"},{"recall_number":"D-0830-2026","recalling_firm":"Mylan Pharmaceuticals Inc","product_type":"drug","classification":"Class II","reason":"Failed Dissolution Specifications","recall_initiation_date":"2026-08-26"},{"recall_number":"D-0831-2026","recalling_firm":"Hikma Pharmaceuticals USA INC.","product_type":"drug","classification":"Class II","reason":"Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).","recall_initiation_date":"2026-08-24"},{"recall_number":"D-0834-2026","recalling_firm":"Teva Pharmaceuticals USA, Inc","product_type":"drug","classification":"Class II","reason":"Presence of Foreign Tablets/Capsules","recall_initiation_date":"2026-08-24"},{"recall_number":"D-0828-2026","recalling_firm":"Lexia LLC","product_type":"drug","classification":"Class II","reason":"CGMP Deviations: Potential contamination of raw material","recall_initiation_date":"2026-08-21"},{"recall_number":"D-0829-2026","recalling_firm":"Lexia LLC","product_type":"drug","classification":"Class II","reason":"CGMP Deviations: Potential contamination of raw material","recall_initiation_date":"2026-08-21"},{"recall_number":"Z-3035-2026","recalling_firm":"Olympus Corporation of the Americas","product_type":"device","classification":"Class II","reason":"Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.","recall_initiation_date":"2026-08-18"},{"recall_number":"H-1265-2026","recalling_firm":"Dreyer's Grand  Ice Cream Inc.","product_type":"food","classification":"Class II","reason":"Foreign object: products may contain glass pieces","recall_initiation_date":"2026-08-18"}],"serious_adverse_events":[{"safetyreportid":"26940054","receivedate":"2026-06-30","seriousness_death":0,"seriousness_hospitalization":1,"drugs":"[{\"name\":\"RAVULIZUMAB\",\"brand\":\"ULTOMIRIS\",\"generic\":\"RAVULIZUMAB\",\"substance\":\"RAVULIZUMAB\",\"indication\":\"Atypical haemolytic uraemic syndrome\"}]","reactions":"[\"Blood potassium increased\",\"Glaucoma\",\"Blood creatinine abnormal\",\"Glomerular filtration rate increased\"]"},{"safetyreportid":"26940056","receivedate":"2026-06-30","seriousness_death":0,"seriousness_hospitalization":1,"drugs":"[{\"name\":\"TACROLIMUS\",\"brand\":\"TACROLIMUS\",\"generic\":\"TACROLIMUS\",\"substance\":\"TACROLIMUS\",\"indication\":\"Immunosuppression\"},{\"name\":\"TACROLIMUS\",\"bra","reactions":"[\"Warm autoimmune haemolytic anaemia\"]"},{"safetyreportid":"26940058","receivedate":"2026-06-30","seriousness_death":1,"seriousness_hospitalization":0,"drugs":"[{\"name\":\"METHOTREXATE\",\"brand\":\"METHOTREXATE\",\"generic\":\"METHOTREXATE\",\"substance\":\"METHOTREXATE SODIUM\",\"indication\":\"Rheumatoid arthritis\"},{\"name\"","reactions":"[\"Seizure\",\"Aspiration\",\"Acute kidney injury\",\"Metal poisoning\",\"Drug-induced liver injury\",\"Product use in unapproved indication\"]"},{"safetyreportid":"26940061","receivedate":"2026-06-30","seriousness_death":0,"seriousness_hospitalization":1,"drugs":"[{\"name\":\"AMJEVITA\",\"brand\":\"AMJEVITA\",\"generic\":\"ADALIMUMAB-ATTO\",\"substance\":\"ADALIMUMAB\",\"indication\":\"Product used for unknown indication\"}]","reactions":"[\"Dyspnoea\",\"Hernia\"]"},{"safetyreportid":"26940065","receivedate":"2026-06-30","seriousness_death":1,"seriousness_hospitalization":0,"drugs":"[{\"name\":\"TECVAYLI\",\"brand\":\"TECVAYLI\",\"generic\":\"TECLISTAMAB-CQYV\",\"substance\":\"TECLISTAMAB\",\"indication\":\"Plasma cell myeloma\"},{\"name\":\"DARZALEX\",\"","reactions":"[\"Death\",\"Product use issue\"]"}],"recent_510k_clearances":[{"k_number":"K261131","applicant":"Shenzhen Osto Medical Technology Co.,Ltd","device_name":"Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)","decision_date":"2026-09-06","decision":"Substantially Equivalent"},{"k_number":"K260396","applicant":"Fidelity BioPharma Co.","device_name":"KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)","decision_date":"2026-09-06","decision":"Substantially Equivalent"},{"k_number":"K254135","applicant":"NOUVAG AG","device_name":"LipoSurg ARTIST","decision_date":"2026-09-05","decision":"Substantially Equivalent"},{"k_number":"K261684","applicant":"Cryosurgery, Inc.","device_name":"FreezeSpray TA","decision_date":"2026-09-05","decision":"Substantially Equivalent"},{"k_number":"K262292","applicant":"Alimetry , Ltd.","device_name":"Gastric Alimetry","decision_date":"2026-09-04","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"}}