The Recall Desk

Manufacturer

Cardinal Health Inc.

240 recalls in our database name Cardinal Health Inc. as the manufacturing or recalling firm.

What the numbers show

Total
240
Critical
2
Severe
8
Most recent
2025-09-03

Of the 240 recalls from Cardinal Health Inc. we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (3%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 240

  • ModerateFDA (Drugs)·D-0573-2025·2025-08-13

    Recombinate antihemophilic factor vials exposed to temperatures outside labeled storage

    Recombinate [Antihemophilic Factor (Recombinant)] 5 mL vials are being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 3 units affected.

    Product
    RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0571-2025·2025-08-13

    Xolair auto-injectors exposed to temperatures outside labeled storage requirements

    Xolair (omalizumab injection) 150 mg/mL auto-injectors are being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 6 units affected.

    Product
    XOLAIR — XOLAIR (OMALIZUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0393-2025·2025-05-07

    Wegovy injection recalled due to temperature exposure during shipping

    Cardinal Health is recalling Wegovy (semaglutide) 2.4 mg injection due to temperature abuse during shipping. Product was removed from refrigerated storage for an extended period due to a distribution center error.

    Product
    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.
    Category
    Drug
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-0131-2024·2023-11-29

    Eye Drops Recalled for Non-Sterility Issues from Manufacturing Facility

    Cardinal Health is recalling LEADER brand Eye Irritation Relief drops due to non-sterility concerns. FDA testing found insanitary conditions and positive bacterial results at the manufacturing facility, affecting 11,629 units distributed nationwide.

    Product
    EYES IRRITATION RELIEF — EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0132-2024·2023-11-29

    FDA Recalls Non-Sterile Dry Eye Relief Drops Due to Bacterial Contamination

    Cardinal Health is recalling all lots of LEADER brand Dry Eye Relief nationwide due to non-sterility. FDA found insanitary manufacturing conditions and positive bacterial test results.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0136-2024·2023-11-29

    LEADER Lubricant Eye Drops Recalled for Non-Sterility and Bacterial Contamination

    Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops due to non-sterility issues. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility in India.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0135-2024·2023-11-29

    Eye drops recalled for non-sterility due to bacterial contamination

    Cardinal Health's LEADER brand Dry Eye Relief eye drops are recalled nationwide due to non-sterility concerns. FDA found insanitary conditions and positive bacterial results from environmental sampling at the manufacturing facility.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0134-2024·2023-11-29

    FDA Recalls LEADER Brand Lubricant Eye Drops Due to Non-Sterility Risk

    Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results from the manufacturing facility.

    Product
    LUBRICANT DROPS — LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0133-2024·2023-11-29

    LEADER Lubricant Eye Drops Recalled Nationwide for Non-Sterility Concerns

    LEADER brand Lubricant Eye Drops are being recalled nationwide due to non-sterility issues. FDA testing found insanitary conditions and positive bacterial contamination at the manufacturing facility.

    Product
    LUBRICANT DROPS — LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0883-2022·2022-05-25

    Trulicity Injection Recalled Due to Temperature Exposure During Shipment

    A batch of Trulicity (dulaglutide) injection was recalled due to temperature exposure during distribution in New Mexico. The product was exposed to temperatures outside its labeled storage requirements due to inclement weather.

    Product
    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
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1941-2021·2021-06-30

    OptiChamber Diamond Spacer Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling 375 OptiChamber Diamond Spacer devices due to temperature exposure during shipping that may cause inaccurate medication delivery results. Affected devices were distributed to Florida, Georgia, and South Carolina.

    Product
    OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2021·2021-06-30

    FREESTYLE LIBRE 14 DAY glucose monitoring system recalled for temperature exposure

    Cardinal Health is recalling 8,959 glucose monitoring kits due to temperature exposure during shipping that may result in inaccurate readings. Affected devices were distributed nationwide.

    Product
    FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2021·2021-06-30

    Prefilled Pen Needles Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling 1,599 boxes of prefilled pen needles that were exposed to low temperatures during shipping, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1937-2021·2021-06-30

    OneTouch Ultrasoft Lancets recalled due to temperature exposure during shipping

    Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.

    Product
    ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2021·2021-06-30

    FreeStyle Libre 2 Glucose Monitoring System Recalled for Inaccurate Results

    Cardinal Health is recalling FreeStyle Libre 2 glucose monitoring systems shipped between February and March 2021 due to temperature exposure during shipment that may cause inaccurate readings.

    Product
    FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1938-2021·2021-06-30

    OneTouch Ultra Test Strips Recalled for Potential Inaccurate Glucose Readings

    Cardinal Health Inc. is recalling OneTouch Ultra Test Strips (item 3510443) because temperature excursions during shipping may have compromised glucose measurement accuracy.

    Product
    ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2021·2021-06-30

    OneTouchDelica Lancets Recalled Due to Temperature Exposure During Shipping

    Cardinal Health Inc. is recalling OneTouchDelica Lancets 33G because devices were exposed to freezing temperatures (31.9°F) during shipping, which may cause inaccurate test results.

    Product
    ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1934-2021·2021-06-30

    Dexcom G6 Sensor 3-Pack Recalled for Temperature-Related Measurement Errors

    Cardinal Health is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack due to temperature exposure during shipping that may cause inaccurate glucose readings. Affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1936-2021·2021-06-30

    OneTouch Ultra Blue test strips recalled for temperature exposure damage

    Cardinal Health is recalling 5,356 boxes of OneTouch Ultra Blue test strips after units were exposed to freezing temperatures during shipping, which may cause inaccurate glucose readings.

    Product
    ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1939-2021·2021-06-30

    OneTouch Delica Lancets Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.

    Product
    ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2021·2021-06-30

    AeroChamber PLS Spacer Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling AeroChamber PLS spacers exposed to freezing temperatures during shipping, which may cause inaccurate drug delivery results. Affected units shipped between February and March 2021 in Florida, Georgia, and South Carolina.

    Product
    AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Cardinal Health

Healthcare company

Country
United States
Founded
1971

Official website

Source: Wikidata (Q902397), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.