{"recall":{"id":"fda-drug-99388","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Precision Dose Inc. recalls Glycopyrrolate Oral Solution","firm":"Precision Dose Inc.","date":"2026-07-14","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).","code":"Lot # 506033, Exp Date: 11/30/2026.","quantity":"N/A","number":"D-0741-2026","classification":"Class II"}],"reason":"Failed Impurities/Degradation Specifications","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=99388","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"b381e8647fa173a2","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=99388","record":[{"status":"Ongoing","city":"South Beloit","state":"IL","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA204438"],"brand_name":["GLYCOPYRROLATE"],"generic_name":["GLYCOPYRROLATE"],"manufacturer_name":["Precision Dose, Inc."],"product_ndc":["68094-073"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["GLYCOPYRROLATE"],"rxcui":["999961"],"spl_id":["0a84301a-febc-4552-97d6-1fd16f191545"],"spl_set_id":["e58f860b-e955-4d71-a128-93bd3812b08d"],"package_ndc":["68094-073-01","68094-073-58"],"original_packager_product_ndc":["49884-042"],"unii":["V92SO9WP2I"]},"product_type":"Drugs","event_id":"99388","recalling_firm":"Precision Dose Inc.","address_1":"722 Progressive Ln","address_2":"N/A","postal_code":"61080-2616","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0741-2026","product_description":"Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).","product_quantity":"N/A","reason_for_recall":"Failed Impurities/Degradation Specifications","recall_initiation_date":"20260714","center_classification_date":"20260805","report_date":"20260729","code_info":"Lot # 506033, Exp Date: 11/30/2026."}]}}