{"recall":{"id":"fda-drug-99934","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Aurobindo Pharma USA Inc recalls amazon","firm":"Aurobindo Pharma USA Inc","date":"2026-09-18","reported":"2026-10-07","status":"Ongoing","classification":"Not Yet Classified","products":[{"name":"amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, Made in India, NDC 72288-692-01. UPC 1 95515 04888 0","code":"Lot# ACD124048A, Exp Date: 11/30/2027.","quantity":"7,836 1000-count bottles","number":"","classification":"Not Yet Classified"}],"reason":"Discoloration: consumer complaints received for discolored tablets","hazard":"FDA Not Yet Classified: not likely to cause adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"7,836 1000-count bottles","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=99934","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f7dbfd602acc036f","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=99934","record":[{"status":"Ongoing","city":"East Windsor","state":"NJ","country":"United States","classification":"Not Yet Classified","openfda":{"application_number":["M013"],"brand_name":["AMAZON BASIC CARE ACETAMINOPHEN"],"generic_name":["ACETAMINOPHEN"],"manufacturer_name":["Amazon.com Services LLC"],"product_ndc":["72288-692"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"substance_name":["ACETAMINOPHEN"],"rxcui":["198440"],"spl_id":["01c0b452-c626-4d2c-8e67-e4c9750195ff"],"spl_set_id":["10ee2f40-858d-bed4-e063-6394a90a86bb"],"package_ndc":["72288-692-10","72288-692-20","72288-692-50","72288-692-01"],"is_original_packager":[true],"unii":["362O9ITL9D"],"upc":["195515048880"]},"product_type":"Drugs","event_id":"99934","recalling_firm":"Aurobindo Pharma USA Inc","address_1":"279 Princeton Hightstown Rd","address_2":"","postal_code":"08520-1401","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"","product_description":"amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, Made in India, NDC 72288-692-01. UPC 1 95515 04888 0","product_quantity":"7,836 1000-count bottles","reason_for_recall":"Discoloration: consumer complaints received for discolored tablets","recall_initiation_date":"20260918","report_date":"20261007","code_info":"Lot# ACD124048A, Exp Date: 11/30/2027.","more_code_info":""}]}}