Dublin, OH, United States
Cardinal Health Inc. recalls
16 recalls recorded since 2018, most recently on 5 August 2025. 10 are listed as ongoing. Status and classification are as published by the FDA.
Recalls16
Ongoing (FDA)10
Terminated or completed6
Class I (FDA)3
Ongoing Class II Drugs
- Recall started
- 5 August 2025
- 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
- Distribution
- KS
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0597-2025
- 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-
Ongoing Class II Drugs
- Recall started
- 30 July 2025
- Reason
- CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Distribution
- Nationwide Within the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0573-2025, D-0572-2025, D-0571-2025
- RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
- Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
- Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Ongoing Class II Drugs
- Recall started
- 9 April 2025
- 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.
- Distribution
- NC, SC, VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0393-2025
- 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, D
Ongoing Class I Drugs
- Recall started
- 31 October 2023
- Reason
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0135-2024, D-0131-2024, D-0134-2024, D-0132-2024, D-0136-2024, D-0133-2024
- 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
- 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 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);
- 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
- 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
- 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
Ongoing Class II Medical devices
- Recall started
- 1 November 2022
- Reason
- Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0356-2023, Z-0358-2023, Z-0360-2023, Z-0359-2023, Z-0361-2023, Z-0357-2023
- Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
- Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
- Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient
- Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
- Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladder of a patient.
- Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
Completed Class I, Class II Drugs
- Recall started
- 5 April 2022
- Reason
- TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
- Distribution
- NM only
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0884-2022, D-0882-2022, D-0883-2022
- 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
- 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 NDC 002-7516-59
- 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
Ongoing Class II Medical devices
- Recall started
- 2 November 2021
- Reason
- Potential for open packaging seals compromising the sterility of the surgical gowns
- Distribution
- Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0376-2022, Z-0375-2022, Z-0371-2022, Z-0370-2022, Z-0372-2022, Z-0369-2022, Z-0377-2022, Z-0374-2022, Z-0368-2022, Z-0373-2022, Z-0378-2022
- RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
- RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
- SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
- SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
- Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
- SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
- RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
- Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
- and 3 more product lines
Ongoing Class I Medical devices
- Recall started
- 4 August 2021
- Reason
- Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
- Distribution
- US Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2286-2021, Z-2285-2021, Z-2284-2021
- Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access d
- Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access
- Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access
Ongoing Class II Medical devices
- Recall started
- 16 March 2021
- Reason
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Distribution
- US Nationwide distribution in the states of FL, GA, SC.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1941-2021, Z-1942-2021, Z-1931-2021, Z-1930-2021, Z-1934-2021, Z-1936-2021, Z-1935-2021, Z-1939-2021, Z-1933-2021, Z-1938-2021, Z-1932-2021, Z-1929-2021 and 2 more
- OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
- ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
- FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
- FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
- DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
- ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
- VAPORIZER VICKS 1.5GAL Item Number: 2354942
- ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
- and 6 more product lines
Terminated Class II Drugs
- Recall started
- 15 March 2021
- Terminated
- 17 June 2024
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Distribution
- FL, GA, SC
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0429-2021, D-0435-2021, D-0448-2021, D-0503-2021, D-0401-2021, D-0451-2021, D-0484-2021, D-0467-2021, D-0471-2021, D-0424-2021, D-0529-2021, D-0414-2021 and 186 more
- Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328
- xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squi
- Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612.
- Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA
- NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS
- NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)
- EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS
- Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110
- and 190 more product lines
Terminated Class III Drugs
- Recall started
- 9 March 2021
- Terminated
- 4 November 2021
- Reason
- Temperature Abuse
- Distribution
- AL, LA, MS, TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0314-2021
- Tremfya (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.
Terminated Class II Medical devices
- Recall started
- 20 April 2020
- Terminated
- 23 July 2020
- Reason
- Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
- Distribution
- US Nationwide distribution NC, KS, and AL.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2050-2020, Z-2049-2020, Z-2051-2020
- Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensi
- B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
- Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for
Terminated Class II Medical devices
- Recall started
- 11 January 2020
- Terminated
- 19 January 2023
- Reason
- The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Distribution
- Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1016-2020, Z-1020-2020, Z-1012-2020, Z-1025-2020, Z-1037-2020, Z-1030-2020, Z-1008-2020, Z-1014-2020, Z-1024-2020, Z-1033-2020, Z-1022-2020, Z-1005-2020 and 27 more
- AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
- AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
- AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
- AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
- AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
- AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
- AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
- ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
- and 31 more product lines
Ongoing Class II Medical devices
- Recall started
- 26 December 2019
- Reason
- The feeding spike sets may leak at the interface of the tube and spike connector.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2102-2020, Z-2105-2020, Z-2103-2020, Z-2100-2020, Z-2101-2020, Z-2104-2020
- Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
- Kangaroo 924 Safety Screw Spike Set, Product Code 775759
- Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
- Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
- Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
- Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
Ongoing Class II Medical devices
- Recall started
- 14 November 2019
- Reason
- Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
- Distribution
- Worldwide distribution - US Nationwide including Puerto Rico and countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaiian, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Repulic, Denmark, Dominican Republic, Ecua
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0729-2020, Z-0728-2020, Z-0730-2020
- Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F
- S.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 Fr
- Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre
Terminated Class II Medical devices
- Recall started
- 16 November 2018
- Terminated
- 4 November 2019
- Reason
- The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
- Distribution
- US state of Florida
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0702-2019
- Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.