--- title: "Cardinal Health Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Cardinal Health 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/cardinal-health-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Cardinal Health Inc. recall records **11** reported ongoing 14 records in this archive. Latest source date Aug 5, 2025. 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 Aug 5, 2025 FDA drug enforcement ### [Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton...](https://isitonrecall.com/recall/fda-drug-d-0597-2025-enoxaparin-sodium-injection-usp-30-mg-0-3-ml-packaged-in-0-3-ml-prefilled-syringes-further-packaged/) Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL Class II Reported ongoing Distribution: KS [Official source for Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further pac...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0597-2025%22) Jul 30, 2025 FDA drug enforcement ### [Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.](https://isitonrecall.com/recall/fda-drug-d-0571-2025-xolair-omalizumab-injection-150-mg-ml-1-auto-injector-rx-only-genentech-inc-south-san-francisco-ca-9/) CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. Class II Reported ongoing Distribution: Nationwide Within the U.S. [Official source for Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Fra...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0571-2025%22) Jul 30, 2025 FDA drug enforcement ### [Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55](https://isitonrecall.com/recall/fda-drug-d-0572-2025-xolair-omalizumab-injection-75-mg-0-5-ml-rx-only-genentech-inc-south-san-francisco-ca-94080-ndc-5024/) CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. Class II Reported ongoing Distribution: Nationwide Within the U.S. [Official source for Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0572-2025%22) Jul 30, 2025 FDA drug enforcement ### [RECOMBINATE, (Antihemophilic Factor (Recombinant)), 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01](https://isitonrecall.com/recall/fda-drug-d-0573-2025-recombinate-antihemophilic-factor-recombinant-5-ml-vials-rx-only-takeda-pharmaceuticals-usa-cambridg/) CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. Class II Reported ongoing Distribution: Nationwide Within the U.S. [Official source for RECOMBINATE, (Antihemophilic Factor (Recombinant)), 5 mL vials, Rx Only, Takeda Pharmaceuticals U...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0573-2025%22) Apr 9, 2025 FDA drug enforcement ### [Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ ...](https://isitonrecall.com/recall/fda-drug-d-0393-2025-wegovy-semaglutide-injection-2-4-mg-0-75-ml-4-single-dose-prefilled-pens-per-carton-for-subcutaneous/) Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated st... Class II Reported ongoing Distribution: NC, SC, VA [Official source for Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subc...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0393-2025%22) Oct 31, 2023 FDA drug enforcement ### [LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Card...](https://isitonrecall.com/recall/fda-drug-d-0131-2024-leader-brand-eye-irritation-relief-polyvinyl-alcohol-0-5-povidone-0-6-tetrahydrozoline-hydrochloride/) Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Class I Reported ongoing Distribution: Nationwide in the USA [Official source for LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydro...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0131-2024%22) Oct 31, 2023 FDA drug enforcement ### [LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India ND...](https://isitonrecall.com/recall/fda-drug-d-0132-2024-leader-brand-dry-eye-relief-carboxymethylcellulose-sodium-1-0-5-fl-oz-15-ml-dropper-bottle-sterile-d/) Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Class I Reported ongoing Distribution: Nationwide in the USA [Official source for LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0132-2024%22) Oct 31, 2023 FDA drug enforcement ### [LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in I...](https://isitonrecall.com/recall/fda-drug-d-0133-2024-leader-brand-lubricant-eye-drops-carboxymethylcellulose-sodium-0-5-0-5-fl-oz-15-ml-dropper-bottles-s/) Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Class I Reported ongoing Distribution: Nationwide in the USA [Official source for LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0133-2024%22) Oct 31, 2023 FDA drug enforcement ### [LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017...](https://isitonrecall.com/recall/fda-drug-d-0134-2024-leader-brand-lubricant-eye-drops-carboxymethylcellulose-sodium-0-5-2-bottles-0-5-fl-oz-15-ml-dropper/) Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Class I Reported ongoing Distribution: Nationwide in the USA [Official source for LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0134-2024%22) Oct 31, 2023 FDA drug enforcement ### [LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 4301...](https://isitonrecall.com/recall/fda-drug-d-0135-2024-leader-brand-dry-eye-relief-polyethylene-glycol-400-0-4-propylene-glycol-0-3-0-33-fl-oz-10-ml-droppe/) Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Class I Reported ongoing Distribution: Nationwide in the USA [Official source for LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (1...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0135-2024%22) Oct 31, 2023 FDA drug enforcement ### [LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70...](https://isitonrecall.com/recall/fda-drug-d-0136-2024-leader-brand-lubricant-eye-drops-propylene-glycol-0-6-0-33-fl-oz-10-ml-dropper-bottles-sterile-distr/) Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Class I Reported ongoing Distribution: Nationwide in the USA [Official source for LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, St...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0136-2024%22) Apr 5, 2022 FDA drug enforcement ### [Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen ...](https://isitonrecall.com/recall/fda-drug-d-0882-2022-humalog-kwikpen-insulin-lispro-injection-u-100-100-units-per-ml-5x3-ml-prefilled-pens-per-box-market/) TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather. Class I Reported completed Distribution: NM only [Official source for Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0882-2022%22) Apr 5, 2022 FDA drug enforcement ### [Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80](https://isitonrecall.com/recall/fda-drug-d-0883-2022-trulicity-dulaglutide-injection-1-5-mg-0-5ml-once-weekly-4-single-dose-pens-rx-only-eli-lilly-and-co/) TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather. Class II Reported completed Distribution: NM only [Official source for Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lil...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0883-2022%22) Apr 5, 2022 FDA drug enforcement ### [Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80](https://isitonrecall.com/recall/fda-drug-d-0884-2022-trulicity-dulaglutide-injection-0-75-mg-0-5ml-once-weekly-4-single-dose-pens-rx-only-eli-lilly-and-c/) TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions Class II Reported completed Distribution: NM only [Official source for Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Li...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0884-2022%22) ## Reasons in these listed records - Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL - CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. - Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extende... - Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. These examples come from this result page and are not a ranking of every recall reason. ## Checking Cardinal Health Inc. ### Is there a recall on cardinal health inc. right now? This archive contains 14 records, including 11 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 Cardinal Health Inc.](https://isitonrecall.com/check/?q=Cardinal%20Health%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)