{"recall":{"id":"fda-drug-99232","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Shimoga Chemicals recalls Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9)","firm":"Shimoga Chemicals","date":"2026-05-19","reported":"2026-07-15","status":"Ongoing","classification":"Class II","products":[{"name":"Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.","code":"Lot #: a) CC/004/24-25, Exp Date September 2029; CC0032526, Exp. Date August 2030 b) CC0442526, Exp. Date Aug 2030; CC/005/24-25, Exp. Date November 2029 c) CC0032526, Exp. Date August 2030; CC/009/24-25, Exp. Date January 2030;CC/005/24-25, Exp. Date November 2029.","quantity":"N/A","number":"D-0691-2026","classification":"Class II"}],"reason":"cGMP deviations","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"CA & FL only","nationwide":false,"states":["CA","FL"],"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=99232","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"0d8f91e82950a256","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=99232","record":[{"status":"Ongoing","city":"Sangli","state":"N/A","country":"India","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99232","recalling_firm":"Shimoga Chemicals","address_1":"W57 A Shimoga Chemicals, Kupwad Midc","address_2":"N/A","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"CA & FL only","recall_number":"D-0691-2026","product_description":"Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.","product_quantity":"N/A","reason_for_recall":"cGMP deviations","recall_initiation_date":"20260519","center_classification_date":"20260715","report_date":"20260715","code_info":"Lot #: a) CC/004/24-25, Exp Date September 2029; CC0032526, Exp. Date August 2030 b) CC0442526, Exp. Date Aug 2030; CC/005/24-25, Exp. Date November 2029 c) CC0032526, Exp. Date August 2030; CC/009/24-25, Exp. Date January 2030;CC/005/24-25, Exp. Date November 2029."}]}}