--- title: "American Regent, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search American Regent, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/american-regent-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # American Regent, Inc. recall records **19** reported ongoing 23 records in this archive. Latest source date Sep 3, 2026. 2 published notices do not supply a closure status. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Sep 3, 2026 FDA company announcement ### [American Regent, Inc.: Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial](https://isitonrecall.com/recall/fdapress-be0db24ddef68063-american-regent-inc-epinephrine-injection-usp-30-mg-30-ml-1-mg-ml-multi-dose-vial/) Presence of particulate matter and lack of sterility assurance Not supplied Published notice; closure not supplied Distribution: Not supplied [Official source for American Regent, Inc.: Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-regent-inc-issues-voluntary-nationwide-recall-three-lots-epinephrine-injection-usp-30-mg-30) Aug 11, 2026 FDA drug enforcement ### [Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY,...](https://isitonrecall.com/recall/fda-drug-d-0865-2026-epinephrine-injection-usp-30-mg-30-ml-1mg-ml-30-ml-multiple-dose-vial-rx-only-for-intravenous-infusi/) Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials. Class I Reported ongoing Distribution: Nationwide within the U.S.A [Official source for Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intraven...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0865-2026%22) Jul 27, 2026 FDA company announcement ### [American Regent, Inc.: Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL](https://isitonrecall.com/recall/fdapress-ca189560b1a5bd76-american-regent-inc-papaverine-hydrochloride-injection-usp-60-mg-2-ml/) Products were found to contain particulate matter Not supplied Published notice; closure not supplied Distribution: Not supplied [Official source for American Regent, Inc.: Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-regent-inc-issues-voluntary-nationwide-recall-one-lot-papaverine-hydrochloride-injection) Jul 24, 2026 FDA drug enforcement ### [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, ...](https://isitonrecall.com/recall/fda-drug-d-0791-2026-nitroglycerin-injection-usp-50-mg-10-ml-5-mg-ml-packaged-in-a-10-ml-vials-ndc-0517-4810-01-b-25x10ml/) Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0791-2026%22) Jul 24, 2026 FDA drug enforcement ### [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 ...](https://isitonrecall.com/recall/fda-drug-d-0792-2026-cyanocobalamin-injection-usp-1-000-mcg-ml-for-im-or-sc-use-only-packaged-in-a-1-ml-multi-dose-vial-n/) Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0792-2026%22) Jul 24, 2026 FDA drug enforcement ### [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 (N...](https://isitonrecall.com/recall/fda-drug-d-0793-2026-cyanocobalamin-injection-usp-10-000-mcg-10-ml-1-000-mcg-ml-for-im-or-sc-use-only-packaged-in-a-10-ml/) Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0793-2026%22) Jul 24, 2026 FDA drug enforcement ### [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 05...](https://isitonrecall.com/recall/fda-drug-d-0794-2026-aminaocaproic-acid-injection-usp-250-mg-ml-5-g-20-ml-packaged-in-a-20-ml-multiple-dose-vial-for-iv-i/) Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0794-2026%22) Jul 24, 2026 FDA drug enforcement ### [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 0517-1001-2...](https://isitonrecall.com/recall/fda-drug-d-0795-2026-atropine-sulfate-injection-usp-1-mg-ml-for-intravenous-use-sterile-packaged-in-a-1-ml-single-dose-vi/) Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Singl...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0795-2026%22) Jul 24, 2026 FDA drug enforcement ### [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,...](https://isitonrecall.com/recall/fda-drug-d-0796-2026-acetylcysteine-solution-usp-10-100-mg-ml-packaged-in-a-4-ml-vial-not-for-injection-ndc-0517-7504-01/) Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 05...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0796-2026%22) Jul 24, 2026 FDA drug enforcement ### [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,...](https://isitonrecall.com/recall/fda-drug-d-0797-2026-acetylcysteine-solution-usp-20-200-mg-ml-packaged-in-a-4-ml-vial-not-for-injection-ndc-0517-7604-01/) Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 05...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0797-2026%22) Jul 24, 2026 FDA drug enforcement ### [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-...](https://isitonrecall.com/recall/fda-drug-d-0798-2026-selenious-acid-injection-usp-12-mcg-2-ml-6-mcg-2ml-for-intravenous-use-packaged-in-a-2ml-single-dose/) Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Si...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0798-2026%22) Jul 24, 2026 FDA drug enforcement ### [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)...](https://isitonrecall.com/recall/fda-drug-d-0799-2026-multrys-trace-elements-injection-4-usp-for-intravenous-infusion-packaged-in-a-1-ml-single-dose-vial/) Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-D...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0799-2026%22) Jul 24, 2026 FDA drug enforcement ### [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, AMERIC...](https://isitonrecall.com/recall/fda-drug-d-0800-2026-papaverine-hcl-injection-usp-60-mg-2-ml-30-mg-ml-packaged-in-a-2ml-single-dose-vial-ndc-0517-4002-01/) Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde Class I Reported ongoing Distribution: Nationwide within the U.S [Official source for Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 05...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0800-2026%22) Jul 24, 2026 FDA drug enforcement ### [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...](https://isitonrecall.com/recall/fda-drug-d-0801-2026-tralement-trace-elements-injection-4-usp-packaged-in-a-1ml-single-dose-vials-ndc-0517-9305-01-and-b/) Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for Tralement (trace elements injection 4\*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0801-2026%22) Jul 24, 2026 FDA drug enforcement ### [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), ...](https://isitonrecall.com/recall/fda-drug-d-0802-2026-nicardipine-hydrochloride-injection-usp-25-mg-10ml-2-5-mg-ml-packaged-in-a-10-ml-single-dose-vial-nd/) Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde Class II Reported ongoing Distribution: Nationwide within the U.S [Official source for niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dos...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0802-2026%22) Apr 16, 2026 FDA drug enforcement ### [Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01](https://isitonrecall.com/recall/fda-drug-d-0494-2026-levocarnitine-injection-usp-1-g-5-ml-200-mg-ml-5-ml-single-dose-vial-for-intravenous-use-rx-only-ame/) Labeling: Missing Label Class III Reported ongoing Distribution: U.S. Nationwide [Official source for Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, R...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0494-2026%22) Apr 18, 2025 FDA drug enforcement ### [niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Alba...](https://isitonrecall.com/recall/fda-drug-d-0398-2025-nicardipine-hydrochloride-injection-usp-25-mg-10-ml-2-5-mg-ml-10-ml-single-dose-vial-rx-only-mfd-for/) Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Onl...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0398-2025%22) Apr 18, 2025 FDA drug enforcement ### [niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial...](https://isitonrecall.com/recall/fda-drug-d-0399-2025-nicardipine-hydrochloride-injection-usp-25-mg-10-ml-2-5-mg-ml-10-ml-single-dose-vial-rx-only-america/) Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Onl...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0399-2025%22) Nov 11, 2024 FDA drug enforcement ### [Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Car...](https://isitonrecall.com/recall/fda-drug-d-0080-2025-venofer-iron-sucrose-injection-usp-100-mg-elemental-iron-per-5-ml-20-mg-ml-5-ml-single-dose-vials-rx/) Presence of Particulate Matter: Potential for glass delamination from the vials. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0080-2025%22) Nov 11, 2024 FDA drug enforcement ### [Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical ...](https://isitonrecall.com/recall/fda-drug-d-0081-2025-venofer-iron-sucrose-injection-usp-50-mg-elemental-iron-per-2-5-ml-20-mg-ml-2-5-ml-single-dose-vials/) Presence of Particulate Matter: Potential for glass delamination from the vials. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-D...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0081-2025%22) ## Reasons in these listed records - Presence of particulate matter and lack of sterility assurance - Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials. - Products were found to contain particulate matter - Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde These examples come from this result page and are not a ranking of every recall reason. ## Checking American Regent, Inc. ### Is there a recall on american regent, inc. right now? This archive contains 23 records, including 19 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search American Regent, Inc.](https://isitonrecall.com/check/?q=American%20Regent%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)