{"recall":{"id":"fda-drug-99773","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Macleods Pharmaceuticals Limited recalls Olanzapine Tablets","firm":"Macleods Pharmaceuticals Limited","date":"2026-08-27","reported":"2026-09-30","status":"Ongoing","classification":"Class III","products":[{"name":"Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.","code":"Lot: BOB22321A, Exp 07-31-2027.","quantity":"22,032 30-count bottles","number":"D-0867-2026","classification":"Class III"}],"reason":"Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"Nationwide in the USA","nationwide":true,"states":[],"units":"22,032 30-count 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=99773","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7978bc2f485469c6","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=99773","record":[{"status":"Ongoing","city":"Tehsil Baddi, District Solan","state":"","country":"India","classification":"Class III","openfda":{"application_number":["ANDA202862"],"brand_name":["OLANZAPINE"],"generic_name":["OLANZAPINE"],"manufacturer_name":["Macleods Pharmaceuticals Limited"],"product_ndc":["33342-067","33342-068","33342-069","33342-070","33342-071","33342-072"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["OLANZAPINE"],"rxcui":["200034","283639","312077","312078","312079","314154"],"spl_id":["2b861570-6b18-4b2b-89aa-29ebde7770f5"],"spl_set_id":["8e095987-bdea-42f2-9550-c7155cf07d30"],"package_ndc":["33342-067-07","33342-067-44","33342-067-12","33342-067-11","33342-068-07","33342-068-44","33342-068-12","33342-068-11","33342-069-07","33342-069-44","33342-069-12","33342-069-11","33342-070-07","33342-070-15","33342-070-12","33342-070-44","33342-070-11","33342-071-07","33342-071-15","33342-071-12","33342-071-44","33342-071-11","33342-072-07","33342-072-15","33342-072-12","33342-072-44","33342-072-11"],"is_original_packager":[true],"upc":["0333342067074","0333342070074","0333342069078","0333342072078","0333342071071","0333342068071"],"nui":["N0000175430"],"pharm_class_epc":["Atypical Antipsychotic [EPC]"],"unii":["N7U69T4SZR"]},"product_type":"Drugs","event_id":"99773","recalling_firm":"Macleods Pharmaceuticals Limited","address_1":"Village Theda","address_2":"Post Office Lodhimajra","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"Nationwide in the USA","recall_number":"D-0867-2026","product_description":"Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.","product_quantity":"22,032 30-count bottles","reason_for_recall":"Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.","recall_initiation_date":"20260827","center_classification_date":"20260922","report_date":"20260930","code_info":"Lot: BOB22321A, Exp 07-31-2027.","more_code_info":""}]}}