{"recall":{"id":"fda-drug-99547","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Shoolin Pharma Chem LLP recalls 5 products","firm":"Shoolin Pharma Chem LLP","date":"2026-08-03","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY \"FOR Prescription Compounding Only\", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05","code":"Batch SDC2505001, Date of Expiry: April 30, 2030.","quantity":"25KG, 250-1gm bags","number":"D-0759-2026","classification":"Class II"},{"name":"TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, \"For Prescription Compounding Only\", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.","code":"Lot: TLF2506001, Date of Expiry: May 31, 2028.","quantity":"1KG - 100-0.1KG(100gm) bags","number":"D-0760-2026","classification":"Class II"},{"name":"TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, \"For Prescription Compounding Only\", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.","code":"Batch TLF2506001, Date of Expiry: May 31, 2028.","quantity":"20 KG, 40 X 0.500KG(500gm) bags","number":"D-0761-2026","classification":"Class II"},{"name":"TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, \"For Prescription Compounding Only\", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08","code":"Batch TLF2506001, Date of Expiry: May 31, 2028.","quantity":"1KG - 20 X 1KG(1000gm) bags","number":"D-0762-2026","classification":"Class II"},{"name":"SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only \" For Prescription Compounding Only\", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.","code":"Lot: SDC2505001, Date of Expiry: April 30, 2030.","quantity":"25 KG, 25 X 1.00 KG bags","number":"D-0763-2026","classification":"Class II"}],"reason":"CGMP Deviations:Noted during FDA inspection","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Distributed Nationwide in the USA","nationwide":true,"states":[],"units":"25KG, 250-1gm bags; 1KG - 100-0.1KG(100gm) bags; 20 KG, 40 X 0.500KG(500gm) bags; 1KG - 20 X 1KG(1000gm) bags; 25 KG, 25 X 1.00 KG bags","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=99547","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"fceb5330fbe6a7f9","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=99547","record":[{"status":"Ongoing","city":"Kadi","state":"","country":"India","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99547","recalling_firm":"Shoolin Pharma Chem LLP","address_1":"408 B/H Ratnamani Tubes","address_2":"Block/Survey No; Nr Maruti Inox","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"Distributed Nationwide in the USA","recall_number":"D-0759-2026","product_description":"SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY \"FOR Prescription Compounding Only\", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India,  (CAS NO. 171599-83-0) NDC 85702-001-05","product_quantity":"25KG, 250-1gm bags","reason_for_recall":"CGMP Deviations:Noted during FDA inspection","recall_initiation_date":"20260803","center_classification_date":"20260813","report_date":"20260819","code_info":"Batch SDC2505001, Date of Expiry: April 30, 2030.","more_code_info":""},{"status":"Ongoing","city":"Kadi","state":"","country":"India","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99547","recalling_firm":"Shoolin Pharma Chem LLP","address_1":"408 B/H Ratnamani Tubes","address_2":"Block/Survey No; 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Rx only \" For Prescription Compounding Only\",  Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.","product_quantity":"25 KG, 25 X 1.00 KG bags","reason_for_recall":"CGMP Deviations:Noted during FDA inspection","recall_initiation_date":"20260803","center_classification_date":"20260813","report_date":"20260819","code_info":"Lot: SDC2505001, Date of Expiry: April 30, 2030.","more_code_info":""}]}}