Cardinal Health Inc. Recalls Recalls by year
A bar chart of the number of recalls naming this company by year.
Recalls by year
Year Recalls 2021 86 2022 3 2023 6 2025 5
Download CSV FDA Recall
Ongoing
Historical record Class II
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, NJ 08540, Outer package - NDC 55154-3543-5, Inner label - NDC 0781-3238-01 by Cardinal Health Inc.
Reason
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL Published
September 3, 2025 Distribution
KS
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FDA Recall
Ongoing
Historical record Class II
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01 by Cardinal Health Inc.
Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. Published
August 13, 2025 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class II
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55 by Cardinal Health Inc.
Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. Published
August 13, 2025 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class II
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55. by Cardinal Health Inc.
Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. Published
August 13, 2025 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class II
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 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14. by Cardinal Health Inc.
Reason
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 extended period of time and inappropriately released. Published
May 7, 2025 Distribution
Multiple states
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FDA Recall
Ongoing
Historical record Class I
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: 70000-0587-1 by Cardinal Health Inc.
Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Published
November 29, 2023 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class I
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 43017, Made in India NDC: 70000-0088-1 by Cardinal Health Inc.
Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Published
November 29, 2023 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class I
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, Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle) by Cardinal Health Inc.
Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Published
November 29, 2023 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class I
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 India NDC: 70000-0090-1 by Cardinal Health Inc.
Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Published
November 29, 2023 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class I
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 NDC: 70000-0089-1 by Cardinal Health Inc.
Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Published
November 29, 2023 Distribution
Nationwide
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FDA Recall
Ongoing
Historical record Class I
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 Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1 by Cardinal Health Inc.
Reason
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. Published
November 29, 2023 Distribution
Nationwide
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FDA Recall
Completed
Historical record Class II
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 by Cardinal Health Inc.
Reason
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions Published
May 25, 2022 Distribution
NM only
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This page lists recalls that name Cardinal Health Inc. as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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