{"recall":{"id":"fda-drug-99662","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"OPTIMAL BALANCE PHARMACY recalls Glutathione 200 mg/mL","firm":"OPTIMAL BALANCE PHARMACY","date":"2026-08-05","reported":"2026-09-09","status":"Ongoing","classification":"Class I","products":[{"name":"Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090","code":"Lot#: LG342009076, Beyond Use Date: 10/4/26","quantity":"53 vials","number":"D-0851-2026","classification":"Class I"}],"reason":"Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"USA Nationwide.","nationwide":true,"states":[],"units":"53 vials","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=99662","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"20b3948f06d53353","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=99662","record":[{"status":"Ongoing","city":"Houston","state":"TX","country":"United States","classification":"Class I","openfda":{},"product_type":"Drugs","event_id":"99662","recalling_firm":"OPTIMAL BALANCE PHARMACY","address_1":"2204 Cypress Creek Pkwy","address_2":"N/A","postal_code":"77090-3113","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"USA Nationwide.","recall_number":"D-0851-2026","product_description":"Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only,  Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090","product_quantity":"53 vials","reason_for_recall":"Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.","recall_initiation_date":"20260805","center_classification_date":"20260916","report_date":"20260909","code_info":"Lot#: LG342009076, Beyond Use Date: 10/4/26","more_code_info":""}]}}