{"recall":{"id":"fda-drug-99551","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Bionpharma Inc. recalls Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg","firm":"Bionpharma Inc.","date":"2026-08-07","reported":"2026-09-09","status":"Ongoing","classification":"Class III","products":[{"name":"Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.","code":"Lot # DMA25006, Exp Date: 11/30/2028.","quantity":"14,232 bottles (1,423,200 tablets)","number":"D-0822-2026","classification":"Class III"}],"reason":"Presence of Foreign Tablets/Capsules","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"14,232 bottles (1,423,200 tablets)","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=99551","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"dbec5f5713ecef25","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=99551","record":[{"status":"Ongoing","city":"Princeton","state":"NJ","country":"United States","classification":"Class III","openfda":{"application_number":["ANDA217000"],"brand_name":["DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE"],"generic_name":["DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE"],"manufacturer_name":["Bionpharma Inc.,"],"product_ndc":["69452-206"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["DOXYLAMINE SUCCINATE","PYRIDOXINE HYDROCHLORIDE"],"rxcui":["1375948"],"spl_id":["4527bd89-c3ee-9cfe-e063-6294a90a3ebc"],"spl_set_id":["0c410285-0ad6-aabc-e063-6294a90abcd8"],"package_ndc":["69452-206-20"],"is_original_packager":[true],"unii":["V9BI9B5YI2","68Y4CF58BV"]},"product_type":"Drugs","event_id":"99551","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-0822-2026","product_description":"Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.","product_quantity":"14,232 bottles (1,423,200 tablets)","reason_for_recall":"Presence of Foreign Tablets/Capsules","recall_initiation_date":"20260807","center_classification_date":"20260828","report_date":"20260909","code_info":"Lot # DMA25006, Exp Date: 11/30/2028.","more_code_info":""}]}}