{"recall":{"id":"fda-drug-99930","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Cipla USA, Inc. recalls Fosfomycin Tromethamine Granules for Oral Solution","firm":"Cipla USA, Inc.","date":"2026-09-18","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.","code":"Lot#: 5KA0405, Exp 12/31/2026.","quantity":"N/A","number":"D-0014-2027","classification":"Class II"}],"reason":"Failed Impurities/Degradation Specifications","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"USA Nationwide.","nationwide":true,"states":[],"units":"N/A","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=99930","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"d7024e12e492d1af","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=99930","record":[{"status":"Ongoing","city":"Warren","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA211881"],"brand_name":["FOSFOMYCIN TROMETHAMINE"],"generic_name":["FOSFOMYCIN TROMETHAMINE"],"manufacturer_name":["Cipla USA Inc."],"product_ndc":["69097-579"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["FOSFOMYCIN TROMETHAMINE"],"rxcui":["808917"],"spl_id":["80c866f4-c984-469e-b2a5-5c23f29b9750"],"spl_set_id":["d101b5d8-bffc-4ee6-b93b-4589fcb8750d"],"package_ndc":["69097-579-67"],"is_original_packager":[true],"unii":["7FXW6U30GY"]},"product_type":"Drugs","event_id":"99930","recalling_firm":"Cipla USA, Inc.","address_1":"10 Independence Blvd","address_2":"N/A","postal_code":"07059-2730","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"USA Nationwide.","recall_number":"D-0014-2027","product_description":"Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.","product_quantity":"N/A","reason_for_recall":"Failed Impurities/Degradation Specifications","recall_initiation_date":"20260918","center_classification_date":"20261006","report_date":"20261014","code_info":"Lot#: 5KA0405, Exp 12/31/2026."}]}}