{"recall":{"id":"fda-drug-99316","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Bionpharma Inc. recalls Divalproex Sodium Delayed-Release Tablets","firm":"Bionpharma Inc.","date":"2026-06-26","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.","code":"Lot# 704C003, Exp. 12/31/2028","quantity":"N/A","number":"D-0742-2026","classification":"Class II"}],"reason":"Presence of Foreign Tablets/Capsules","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US 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=99316","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c63ffd8b5db0954c","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=99316","record":[{"status":"Ongoing","city":"Princeton","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA078853"],"brand_name":["DIVALPROEX SODIUM"],"generic_name":["DIVALPROEX SODIUM"],"manufacturer_name":["Bionpharma Inc."],"product_ndc":["69452-433","69452-434","69452-435"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["DIVALPROEX SODIUM"],"rxcui":["1099625","1099678","1099870"],"spl_id":["ba8a3e85-d09c-4e11-820d-1a6e45974fdd"],"spl_set_id":["19064624-81d1-4ce3-bfe4-955bad6af6a2"],"package_ndc":["69452-433-13","69452-433-20","69452-433-30","69452-434-13","69452-434-20","69452-434-30","69452-435-13","69452-435-20","69452-435-30"],"is_original_packager":[true],"unii":["644VL95AO6"]},"product_type":"Drugs","event_id":"99316","recalling_firm":"Bionpharma Inc.","address_1":"400 Alexander Park Ste 2-4b","address_2":"N/A","postal_code":"08540-6539","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0742-2026","product_description":"Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.","product_quantity":"N/A","reason_for_recall":"Presence of Foreign Tablets/Capsules","recall_initiation_date":"20260626","center_classification_date":"20260806","report_date":"20260729","code_info":"Lot# 704C003, Exp. 12/31/2028"}]}}