{"recall":{"id":"fda-drug-99503","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"American Regent, Inc. recalls 12 products","firm":"American Regent, Inc.","date":"2026-07-24","reported":"2026-08-26","status":"Ongoing","classification":"Class I","products":[{"name":"Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967.","code":"Lot #: 24291, Exp. Date: 8/31/2026","quantity":"98,200 vials","number":"D-0791-2026","classification":"Class II"},{"name":"Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","code":"Lot #: 24297, Exp. Date 8/31/2026; 24364, Exp. Date: 10/31/2026;","quantity":"235,350 vials","number":"D-0792-2026","classification":"Class II"},{"name":"Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","code":"Lot #: 25082, Exp. Date: 3/31/2027.","quantity":"26,450 vials","number":"D-0793-2026","classification":"Class II"},{"name":"AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.","code":"Lot #: 24299, Exp. Date: 8/31/2026.","quantity":"63,200 vials","number":"D-0794-2026","classification":"Class II"},{"name":"Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967.","code":"Lot #: 24353, Exp. Date: 9/30/2026.","quantity":"89,775 vials","number":"D-0795-2026","classification":"Class II"},{"name":"ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","code":"Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027","quantity":"316,450 vials","number":"D-0796-2026","classification":"Class II"},{"name":"ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","code":"Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.","quantity":"169,200 vials","number":"D-0797-2026","classification":"Class II"},{"name":"Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","code":"Lot #: 25090, Exp. Date 2/28/2027.","quantity":"41,680 vials","number":"D-0798-2026","classification":"Class II"},{"name":"Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","code":"Lot #: 25163, Exp. Date: 4/30/2027.","quantity":"185,775 vials","number":"D-0799-2026","classification":"Class II"},{"name":"Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","code":"Lot #: 25202, Exp. Date: 11/30/2026.","quantity":"86,100 vials","number":"D-0800-2026","classification":"Class I"},{"name":"Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","code":"Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.","quantity":"323,000 vials","number":"D-0801-2026","classification":"Class II"},{"name":"niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.","code":"Lot #: 25295N0C0, Exp. Date: 04/30/2027.","quantity":"43,460 vials","number":"D-0802-2026","classification":"Class II"}],"reason":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Nationwide within the U.S","nationwide":true,"states":[],"units":"98,200 vials; 235,350 vials; 26,450 vials; 63,200 vials; 89,775 vials; 316,450 vials; 169,200 vials; 41,680 vials; 185,775 vials; 86,100 vials; 323,000 vials; 43,460 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=99503","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"4c15ebd75e8942ee","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=99503","record":[{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA072034"],"brand_name":["NITROGLYCERIN"],"generic_name":["NITROGLYCERIN"],"manufacturer_name":["American Regent, Inc."],"product_ndc":["0517-4810"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["NITROGLYCERIN"],"rxcui":["237205"],"spl_id":["ee83c8b9-c31a-4f32-9e9d-0370545204cb"],"spl_set_id":["8c52cdf6-87be-4719-b105-f08be096d462"],"package_ndc":["0517-4810-01","0517-4810-25"],"is_original_packager":[true],"upc":["0305174810258"],"nui":["N0000175415","M0014874","N0000009909"],"pharm_class_epc":["Nitrate Vasodilator [EPC]"],"pharm_class_cs":["Nitrates [CS]"],"pharm_class_pe":["Vasodilation [PE]"],"unii":["G59M7S0WS3"]},"product_type":"Drugs","event_id":"99503","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0791-2026","product_description":"Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967.","product_quantity":"98,200 vials","reason_for_recall":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde","recall_initiation_date":"20260724","center_classification_date":"20260826","report_date":"20260826","code_info":"Lot #: 24291, Exp. Date: 8/31/2026","more_code_info":""},{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA080737"],"brand_name":["CYANOCOBALAMIN"],"generic_name":["CYANOCOBALAMIN"],"manufacturer_name":["American Regent, Inc."],"product_ndc":["0517-0031","0517-0032","0517-0130"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAMUSCULAR","SUBCUTANEOUS"],"substance_name":["CYANOCOBALAMIN"],"rxcui":["309594"],"spl_id":["28421ba1-7e37-429c-9c66-62cc36f5847c"],"spl_set_id":["2fb653d6-e2b2-4969-831b-c0dc37b9c0cc"],"package_ndc":["0517-0031-01","0517-0031-25","0517-0032-01","0517-0032-25","0517-0130-01"],"is_original_packager":[true],"upc":["0305170031251","0305170032258"],"nui":["M0022794","N0000175951"],"pharm_class_cs":["Vitamin B 12 [CS]"],"pharm_class_epc":["Vitamin B12 [EPC]"],"unii":["P6YC3EG204"]},"product_type":"Drugs","event_id":"99503","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0792-2026","product_description":"Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","product_quantity":"235,350 vials","reason_for_recall":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde","recall_initiation_date":"20260724","center_classification_date":"20260826","report_date":"20260826","code_info":"Lot #: 24297, Exp. Date 8/31/2026; 24364, Exp. Date: 10/31/2026;","more_code_info":""},{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA080737"],"brand_name":["CYANOCOBALAMIN"],"generic_name":["CYANOCOBALAMIN"],"manufacturer_name":["American Regent, Inc."],"product_ndc":["0517-0031","0517-0032","0517-0130"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAMUSCULAR","SUBCUTANEOUS"],"substance_name":["CYANOCOBALAMIN"],"rxcui":["309594"],"spl_id":["28421ba1-7e37-429c-9c66-62cc36f5847c"],"spl_set_id":["2fb653d6-e2b2-4969-831b-c0dc37b9c0cc"],"package_ndc":["0517-0031-01","0517-0031-25","0517-0032-01","0517-0032-25","0517-0130-01"],"is_original_packager":[true],"upc":["0305170031251","0305170032258"],"nui":["M0022794","N0000175951"],"pharm_class_cs":["Vitamin B 12 [CS]"],"pharm_class_epc":["Vitamin B12 [EPC]"],"unii":["P6YC3EG204"]},"product_type":"Drugs","event_id":"99503","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0793-2026","product_description":"Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","product_quantity":"26,450 vials","reason_for_recall":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde","recall_initiation_date":"20260724","center_classification_date":"20260826","report_date":"20260826","code_info":"Lot #: 25082, Exp. Date: 3/31/2027.","more_code_info":""},{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA071192"],"brand_name":["AMINOCAPROIC ACID"],"generic_name":["AMINOCAPROIC ACID"],"manufacturer_name":["American Regent, Inc."],"product_ndc":["0517-9120"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["AMINOCAPROIC ACID"],"rxcui":["238719"],"spl_id":["c62d23ae-6f20-4a53-94e4-4ba5d25b7231"],"spl_set_id":["f4f65667-c349-420b-b7b7-f20f3a4e4d4e"],"package_ndc":["0517-9120-25","0517-9120-01"],"is_original_packager":[true],"upc":["0305179120253"],"nui":["N0000175634","N0000175632"],"pharm_class_epc":["Antifibrinolytic Agent [EPC]"],"pharm_class_pe":["Decreased Fibrinolysis [PE]"],"unii":["U6F3787206"]},"product_type":"Drugs","event_id":"99503","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0794-2026","product_description":"AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01),  and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.","product_quantity":"63,200 vials","reason_for_recall":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde","recall_initiation_date":"20260724","center_classification_date":"20260826","report_date":"20260826","code_info":"Lot #: 24299, Exp. Date: 8/31/2026.","more_code_info":""},{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA216120"],"brand_name":["ATROPINE SULFATE"],"generic_name":["ATROPINE SULFATE"],"manufacturer_name":["American Regent, Inc."],"product_ndc":["0517-1001","0517-1004"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["ATROPINE SULFATE"],"rxcui":["1190795","1666781"],"spl_id":["1c500ed9-94a9-472c-bfb7-50e1fcfc31fb"],"spl_set_id":["6fee1727-52b7-4f73-ab45-ef47d6a1c5bb"],"package_ndc":["0517-1004-01","0517-1004-25","0517-1001-01","0517-1001-25"],"is_original_packager":[true],"upc":["0305171004254","0305171001253"],"unii":["03J5ZE7KA5"]},"product_type":"Drugs","event_id":"99503","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0795-2026","product_description":"Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967.","product_quantity":"89,775 vials","reason_for_recall":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde","recall_initiation_date":"20260724","center_classification_date":"20260826","report_date":"20260826","code_info":"Lot #: 24353, Exp. Date: 9/30/2026.","more_code_info":""},{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA072489"],"brand_name":["ACETYLCYSTEINE"],"generic_name":["ACETYLCYSTEINE"],"manufacturer_name":["American Regent, Inc."],"product_ndc":["0517-7504","0517-7604","0517-7510","0517-7610","0517-7630"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["RESPIRATORY (INHALATION)"],"substance_name":["ACETYLCYSTEINE"],"rxcui":["307718","307719"],"spl_id":["2bcb9dd3-17f8-439e-a395-aa081c5cc4bf"],"spl_set_id":["f56b4087-db48-4fd7-84ec-9c927962b805"],"package_ndc":["0517-7504-25","0517-7604-25","0517-7510-03","0517-7610-03","0517-7630-03","0517-7504-01"],"is_original_packager":[true],"upc":["0305177510032","0305177604250","0305177504253","0305177610039"],"nui":["N0000175429","N0000175961","N0000008867","N0000175960","N0000175776","N0000175547"],"pharm_class_epc":["Antidote [EPC]","Antidote for Acetaminophen Overdose [EPC]","Mucolytic [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Glutathione Concentration [PE]"],"pharm_class_moa":["Reduction Activity [MoA]"],"unii":["WYQ7N0BPYC"]},"product_type":"Drugs","event_id":"99503","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0796-2026","product_description":"ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","product_quantity":"316,450 vials","reason_for_recall":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde","recall_initiation_date":"20260724","center_classification_date":"20260826","report_date":"20260826","code_info":"Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date:  8/31/2027","more_code_info":""},{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA072489"],"brand_name":["ACETYLCYSTEINE"],"generic_name":["ACETYLCYSTEINE"],"manufacturer_name":["American Regent, Inc."],"product_ndc":["0517-7504","0517-7604","0517-7510","0517-7610","0517-7630"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["RESPIRATORY (INHALATION)"],"substance_name":["ACETYLCYSTEINE"],"rxcui":["307718","307719"],"spl_id":["2bcb9dd3-17f8-439e-a395-aa081c5cc4bf"],"spl_set_id":["f56b4087-db48-4fd7-84ec-9c927962b805"],"package_ndc":["0517-7504-25","0517-7604-25","0517-7510-03","0517-7610-03","0517-7630-03","0517-7604-01"],"is_original_packager":[true],"upc":["0305177510032","0305177604250","0305177504253","0305177610039"],"nui":["N0000175429","N0000175961","N0000008867","N0000175960","N0000175776","N0000175547"],"pharm_class_epc":["Antidote [EPC]","Antidote for Acetaminophen Overdose [EPC]","Mucolytic [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Glutathione Concentration [PE]"],"pharm_class_moa":["Reduction Activity [MoA]"],"unii":["WYQ7N0BPYC"]},"product_type":"Drugs","event_id":"99503","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0797-2026","product_description":"ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","product_quantity":"169,200 vials","reason_for_recall":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde","recall_initiation_date":"20260724","center_classification_date":"20260826","report_date":"20260826","code_info":"Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.","more_code_info":""},{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["NDA209379"],"brand_name":["SELENIOUS ACID"],"generic_name":["SELENIOUS ACID"],"manufacturer_name":["American Regent, Inc."],"product_ndc":["0517-6502","0517-6560"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["SELENIUM"],"rxcui":["2176324","2591522"],"spl_id":["4f6657ea-8dfd-4a74-8a36-9855ca7fd34a"],"spl_set_id":["49324999-50e3-43ed-a8dd-156d6dbedd9f"],"package_ndc":["0517-6560-01","0517-6560-05","0517-6502-01","0517-6502-10"],"is_original_packager":[true],"upc":["0305176502106"],"unii":["H6241UJ22B"]},"product_type":"Drugs","event_id":"99503","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0798-2026","product_description":"Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","product_quantity":"41,680 vials","reason_for_recall":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde","recall_initiation_date":"20260724","center_classification_date":"20260826","report_date":"20260826","code_info":"Lot #: 25090, Exp. Date 2/28/2027.","more_code_info":""},{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["NDA209376"],"brand_name":["MULTRYS"],"generic_name":["TRACE ELEMENTS INJECTION 4"],"manufacturer_name":["American Regent, Inc."],"product_ndc":["0517-9302"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["ZINC SULFATE","CUPRIC SULFATE","MANGANESE SULFATE","SELENIOUS ACID"],"rxcui":["2568573","2568579"],"spl_id":["5c07b457-1143-440c-9975-90c16852a103"],"spl_set_id":["995f1efa-aca0-4b6c-9099-f8e757c2133a"],"package_ndc":["0517-9302-01","0517-9302-25"],"is_original_packager":[true],"upc":["0305178201250"],"unii":["89DS0H96TB","LRX7AJ16DT","W00LYS4T26","F6A27P4Q4R"]},"product_type":"Drugs","event_id":"99503","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0799-2026","product_description":"Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","product_quantity":"185,775 vials","reason_for_recall":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde","recall_initiation_date":"20260724","center_classification_date":"20260826","report_date":"20260826","code_info":"Lot #: 25163, Exp. Date: 4/30/2027.","more_code_info":""},{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class I","openfda":{"brand_name":["PAPAVERINE HYDROCHLORIDE"],"generic_name":["PAPAVERINE HYDROCHLORIDE"],"manufacturer_name":["American Regent, Inc."],"product_ndc":["0517-4002"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["PAPAVERINE HYDROCHLORIDE"],"rxcui":["1789947"],"spl_id":["402161da-fe45-4b0f-a5ca-a230593cc434"],"spl_set_id":["9e5e2ce4-7a57-4c61-a826-64c8d11d038e"],"package_ndc":["0517-4002-01","0517-4002-25"],"is_original_packager":[true],"upc":["0305174002257"],"unii":["23473EC6BQ"]},"product_type":"Drugs","event_id":"99503","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0800-2026","product_description":"Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","product_quantity":"86,100 vials","reason_for_recall":"Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde","recall_initiation_date":"20260724","center_classification_date":"20260826","report_date":"20260826","code_info":"Lot #: 25202, Exp. Date: 11/30/2026.","more_code_info":""},{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["NDA209376"],"brand_name":["TRALEMENT"],"generic_name":["TRACE ELEMENTS INJECTION 4"],"manufacturer_name":["American Regent, Inc."],"product_ndc":["0517-9305"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["ZINC SULFATE","CUPRIC SULFATE","MANGANESE SULFATE","SELENIOUS ACID"],"rxcui":["2693627","2693633"],"spl_id":["98253bed-5ff4-478f-aff5-c35944fad08a"],"spl_set_id":["a49ffb90-f307-433e-a86e-aaea6d6a9982"],"package_ndc":["0517-9305-01","0517-9305-25"],"is_original_packager":[true],"upc":["0305178201250"],"unii":["89DS0H96TB","LRX7AJ16DT","W00LYS4T26","F6A27P4Q4R"]},"product_type":"Drugs","event_id":"99503","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0801-2026","product_description":"Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.","product_quantity":"323,000 vials","reason_for_recall":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde","recall_initiation_date":"20260724","center_classification_date":"20260826","report_date":"20260826","code_info":"Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.","more_code_info":""},{"status":"Ongoing","city":"Shirley","state":"NY","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA090534"],"brand_name":["NICARDIPINE HYDROCHLORIDE"],"generic_name":["NICARDIPINE HYDROCHLORIDE"],"manufacturer_name":["Civica, Inc."],"product_ndc":["72572-470"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["NICARDIPINE HYDROCHLORIDE"],"rxcui":["858607"],"spl_id":["fba70df6-5d37-4a12-bce3-e6fb1b0c72b2"],"spl_set_id":["30fb3a4d-fa75-42fd-b4b6-2a21f202027f"],"package_ndc":["72572-470-01","72572-470-10"],"is_original_packager":[true],"unii":["K5BC5011K3"]},"product_type":"Drugs","event_id":"99503","recalling_firm":"American Regent, Inc.","address_1":"5 Ramsay Rd","address_2":"","postal_code":"11967-4701","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0802-2026","product_description":"niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.","product_quantity":"43,460 vials","reason_for_recall":"Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde","recall_initiation_date":"20260724","center_classification_date":"20260826","report_date":"20260826","code_info":"Lot #: 25295N0C0, Exp. Date: 04/30/2027.","more_code_info":""}]}}