Recall Register

Cardinal Health Inc.: FDA recalls

FDA enforcement reports name Cardinal Health Inc. as the recalling firm in 12 events. The events have 240 product records. The recalls started from 2018 to 2025.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

12 events, newest first.

FDA enforcement events of Cardinal Health Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
5 Aug 2025Enoxaparin 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 0781-3238-01DrugClass II1Ongoing
30 Jul 2025Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.DrugClass II3Ongoing
9 Apr 2025Wegovy (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.DrugClass II1Ongoing
31 Oct 2023LEADER 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: 70000-0087-1DrugClass I6Ongoing
5 Apr 2022Humalog 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 NDC 002-7516-59DrugClass I3Completed
16 Mar 2021FREESTYLE LANCETS 28G 100CT Item Number:2975670DeviceClass II14Ongoing
15 Mar 2021THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETSDrugClass II198Terminated
9 Mar 2021Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01.DrugClass III1Terminated
20 Apr 2020B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.DeviceClass II3Terminated
26 Dec 2019Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100DeviceClass II6Ongoing
14 Nov 2019S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine…DeviceClass II3Ongoing
16 Nov 2018Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Cardinal Health Inc.: events for each product type
TypeEvents
Drug7
Device5
Cardinal Health Inc.: events in each class
ClassEvents
Class II9
Class I2
Class III1
Share of the events of the firm in Class I
17%
Share of all events on the register in Class I
18%
Events with the status Ongoing
7

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Cardinal Health Inc., by the year that the recall started. The largest year is 2021, with 3 events.

Official channels

Cite this page

Recall Register. Cardinal Health Inc.: FDA recalls. https://recallregister.com/firm/cardinal-health-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
OH

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Cardinal Health Inc. have?
Class II: 9 events. Class I: 2 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Cardinal Health Inc. have?
Drug: 7 events. Device: 5 events.
What is the newest FDA recall of Cardinal Health Inc.?
FDA event 97380, which the firm started on 5 Aug 2025. The first product in the record is: 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
How many FDA recalls of Cardinal Health Inc. have the status Ongoing?
7 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.