{"recall":{"id":"fda-drug-99794","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"SUN PHARMA /TARO recalls Lidocaine Ointment USP","firm":"SUN PHARMA /TARO","date":"2026-08-31","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5","code":"Lot # AD48154, Exp: 4/30/2027.","quantity":"65,328 50g jars","number":"D-0848-2026","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).","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide in the USA","nationwide":true,"states":[],"units":"65,328 50g jars","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=99794","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"92e571acae26d9ed","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=99794","record":[{"status":"Ongoing","city":"Hawthorne","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA086724"],"brand_name":["LIDOCAINE"],"generic_name":["LIDOCAINE"],"manufacturer_name":["Sun Pharmaceutical Industries, Inc."],"product_ndc":["51672-3008"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"substance_name":["LIDOCAINE"],"rxcui":["1543069"],"spl_id":["5353eb70-1eeb-5479-e063-6394a90a2e2b"],"spl_set_id":["5eb2c62f-5352-41d7-bd66-c65b1988a9ab"],"package_ndc":["51672-3008-5","51672-3008-3"],"is_original_packager":[true],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_cs":["Amides [CS]"],"pharm_class_pe":["Local Anesthesia [PE]"],"unii":["98PI200987"]},"product_type":"Drugs","event_id":"99794","recalling_firm":"SUN PHARMA /TARO","address_1":"3 Skyline Dr","address_2":"N/A","postal_code":"10532-2174","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the USA","recall_number":"D-0848-2026","product_description":"Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5","product_quantity":"65,328 50g jars","reason_for_recall":"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":"20260831","center_classification_date":"20260915","report_date":"20260923","code_info":"Lot # AD48154, Exp: 4/30/2027.","more_code_info":""}]}}