{"recall":{"id":"fda-drug-99674","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"American Health Packaging recalls Buprenorphine Sublingual Tablets (C-III)","firm":"American Health Packaging","date":"2026-08-19","reported":"2026-09-09","status":"Ongoing","classification":"Class III","products":[{"name":"Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).","code":"Lot # 1030023, Exp Date: 06/30/2027.","quantity":"10,953 cartons.","number":"D-0840-2026","classification":"Class III"}],"reason":"Labeling: Label Mix-up","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"10,953 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=99674","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"42666f7bf27afe85","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=99674","record":[{"status":"Ongoing","city":"Columbus","state":"OH","country":"United States","classification":"Class III","openfda":{"application_number":["ANDA207276"],"brand_name":["BUPRENORPHINE"],"generic_name":["BUPRENORPHINE"],"manufacturer_name":["American Health Packaging"],"product_ndc":["60687-481","60687-492"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["SUBLINGUAL"],"substance_name":["BUPRENORPHINE HYDROCHLORIDE"],"rxcui":["351264","351265"],"spl_id":["2a815afd-4f27-120b-e063-6394a90a82a0"],"spl_set_id":["8d38f7aa-da0b-40ad-b0d1-4284c71042ed"],"package_ndc":["60687-481-11","60687-481-21","60687-492-11","60687-492-21"],"original_packager_product_ndc":["42858-501","42858-502"],"unii":["56W8MW3EN1"]},"product_type":"Drugs","event_id":"99674","recalling_firm":"American Health Packaging","address_1":"2550 John Glenn Ave Ste A","address_2":"N/A","postal_code":"43217-1188","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0840-2026","product_description":"Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).","product_quantity":"10,953 cartons.","reason_for_recall":"Labeling: Label Mix-up","recall_initiation_date":"20260819","center_classification_date":"20260914","report_date":"20260909","code_info":"Lot # 1030023, Exp Date: 06/30/2027.","more_code_info":""}]}}