{"recall":{"id":"fda-drug-99902","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Par Health USA, LLC recalls Buprenorphine Hydrochloride","firm":"Par Health USA, LLC","date":"2026-09-08","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05","code":"Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027","quantity":"154210 bottles","number":"D-0876-2026","classification":"Class II"}],"reason":"Crystallization","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide","nationwide":true,"states":[],"units":"154210 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=99902","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7945bf41d4fc36a3","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=99902","record":[{"status":"Ongoing","city":"Rochester","state":"MI","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA206586"],"brand_name":["BUPRENORPHINE HYDROCHLORIDE"],"generic_name":["BUPRENORPHINE HYDROCHLORIDE"],"manufacturer_name":["Par Health USA, LLC"],"product_ndc":["42023-179"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAMUSCULAR","INTRAVENOUS"],"substance_name":["BUPRENORPHINE HYDROCHLORIDE"],"rxcui":["238129"],"spl_id":["32a7af7e-3f90-4881-9075-473644237017"],"spl_set_id":["34767dda-ce52-4f98-a45f-bb5cee0cd5e6"],"package_ndc":["42023-179-05"],"is_original_packager":[true],"unii":["56W8MW3EN1"]},"product_type":"Drugs","event_id":"99902","recalling_firm":"Par Health USA, LLC","address_1":"870 Parkdale Rd","address_2":"","postal_code":"48307-1740","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide","recall_number":"D-0876-2026","product_description":"Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05","product_quantity":"154210 bottles","reason_for_recall":"Crystallization","recall_initiation_date":"20260908","center_classification_date":"20260929","report_date":"20261007","code_info":"Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027  Lot#:89909, Exp Date 05/2027","more_code_info":""}]}}