{"recall":{"id":"fda-drug-99544","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Lupin Pharmaceuticals Inc. recalls Clobetasol Propionate Cream USP","firm":"Lupin Pharmaceuticals Inc.","date":"2026-08-03","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.","code":"Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026","quantity":"5082 tubes","number":"D-0789-2026","classification":"Class II"}],"reason":"Failed content uniformity specifications.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"USA Nationwide","nationwide":true,"states":[],"units":"5082 tubes","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=99544","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"d92b92c8092b56ed","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=99544","record":[{"status":"Ongoing","city":"Naples","state":"FL","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA210208"],"brand_name":["CLOBETASOL PROPIONATE"],"generic_name":["CLOBETASOL PROPIONATE"],"manufacturer_name":["Lupin Pharmaceuticals, Inc."],"product_ndc":["68180-956"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"substance_name":["CLOBETASOL PROPIONATE"],"rxcui":["861495"],"spl_id":["7b59c4a0-68c3-4423-adea-a4e2d5b1f96d"],"spl_set_id":["0a267001-0bff-471c-8852-808e6e3ea37c"],"package_ndc":["68180-956-01","68180-956-02","68180-956-03","68180-956-04"],"is_original_packager":[true],"unii":["779619577M"]},"product_type":"Drugs","event_id":"99544","recalling_firm":"Lupin Pharmaceuticals Inc.","address_1":"5801 Pelican Bay Blvd Ste 500","address_2":"N/A","postal_code":"34108-2734","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-0789-2026","product_description":"Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.","product_quantity":"5082 tubes","reason_for_recall":"Failed content uniformity specifications.","recall_initiation_date":"20260803","center_classification_date":"20260826","report_date":"20260902","code_info":"Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026"}]}}