{"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":69557,"adverse_events":180400,"clearances_510k":1171,"drug_labels":51642},"recent":{"recent_recalls":[{"recall_number":"D-0853-2026","recalling_firm":"Pfizer","product_type":"drug","classification":"Class II","reason":"Lack of Assurance of Sterility","recall_initiation_date":"2026-09-04"},{"recall_number":"D-0852-2026","recalling_firm":"Inventia Healthcare Limited","product_type":"drug","classification":"Class II","reason":"Failed Dissolution Specifications","recall_initiation_date":"2026-09-03"},{"recall_number":"D-0864-2026","recalling_firm":"OurPharma LLC","product_type":"drug","classification":"Class II","reason":"Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).","recall_initiation_date":"2026-09-03"},{"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-0848-2026","recalling_firm":"SUN PHARMA /TARO","product_type":"drug","classification":"Class II","reason":"Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).","recall_initiation_date":"2026-08-31"},{"recall_number":"H-1387-2026","recalling_firm":"Tiffany Food Corp","product_type":"food","classification":"Class III","reason":"Unapproved dye Ponceau 4R","recall_initiation_date":"2026-08-28"},{"recall_number":"H-1380-2026","recalling_firm":"Frutas y Hortalizas del Sur S.A.","product_type":"food","classification":"Class I","reason":"Potential E. coli O145:H28 Contamination","recall_initiation_date":"2026-08-28"},{"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"}],"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":"K261859","applicant":"Anhui JBH Medical Apparatus Co., Ltd.","device_name":"Electric Scooter (FDB08, FDB08A, FDB12)","decision_date":"2026-09-19","decision":"Substantially Equivalent"},{"k_number":"K252723","applicant":"Fotona D.O.O.","device_name":"Dynamis Pro Family","decision_date":"2026-09-19","decision":"Substantially Equivalent"},{"k_number":"K241973","applicant":"Lumenis Be, Ltd.","device_name":"SmartIPL_NI System","decision_date":"2026-09-19","decision":"Substantially Equivalent"},{"k_number":"K262262","applicant":"Neptune Medical, Inc.","device_name":"Pathfinder Endoscope Overtube","decision_date":"2026-09-18","decision":"Substantially Equivalent"},{"k_number":"K254171","applicant":"Shenzhen Mericonn Technology Co., Ltd.","device_name":"Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)","decision_date":"2026-09-18","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"}}