{"recall":{"id":"fda-drug-99319","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Lannett Company Inc. recalls Dextroamphetamine Saccharate","firm":"Lannett Company Inc.","date":"2026-06-26","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.","code":"Lot#: 25285401A, Exp. Date: 04/2027","quantity":"1392 bottles","number":"D-0660-2026","classification":"Class II"}],"reason":"Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"1392 bottles","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=99319","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"242ddb8d78599c56","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","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=99319","record":[{"status":"Ongoing","city":"Seymour","state":"IN","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA214403"],"brand_name":["DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE"],"generic_name":["DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE"],"manufacturer_name":["Lannett Company, Inc."],"product_ndc":["0527-0790","0527-0791","0527-0792","0527-0793","0527-0794","0527-0795"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["DEXTROAMPHETAMINE SULFATE","DEXTROAMPHETAMINE SACCHARATE","AMPHETAMINE ASPARTATE MONOHYDRATE","AMPHETAMINE SULFATE"],"rxcui":["861221","861223","861225","861227","861232","861237"],"spl_id":["84f9b61a-9585-46d5-bade-fa9c4e3e8d99"],"spl_set_id":["e95bdaf9-007a-4088-b969-fee38a97a475"],"package_ndc":["0527-0790-37","0527-0791-37","0527-0792-37","0527-0793-37","0527-0794-37","0527-0795-37"],"is_original_packager":[true],"upc":["0305270791376","0305870193310","0305270790379","0305270794377"],"unii":["6DPV8NK46S","JJ768O327N","G83415V073","O1ZPV620O4"]},"product_type":"Drugs","event_id":"99319","recalling_firm":"Lannett Company Inc.","address_1":"1101 C Ave W","address_2":"N/A","postal_code":"47274-3342","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0660-2026","product_description":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.","product_quantity":"1392 bottles","reason_for_recall":"Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.","recall_initiation_date":"20260626","center_classification_date":"20260702","report_date":"20260708","code_info":"Lot#: 25285401A, Exp. Date: 04/2027"}]}}