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Cardinal Health Recalls
316 recalls on record · January 30, 2013 to September 3, 2025 · Drugs, Food & Beverage, Medical Devices
Recalls by year
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25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 3, 2025DrugsFDA
Cardinal Health Inc. recalls Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 pref
Hazard: Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
August 13, 2025DrugsFDA
Cardinal Health Inc. recalls RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142
Hazard: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
August 13, 2025DrugsFDA
Cardinal Health Inc. recalls Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Hazard: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
August 13, 2025DrugsFDA
Cardinal Health Inc. recalls Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 5
Hazard: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
May 7, 2025DrugsFDA
Cardinal Health Inc. recalls Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx O
Hazard: 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.
November 29, 2023DrugsFDA
Cardinal Health Inc. recalls LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 29, 2023DrugsFDA
Cardinal Health Inc. recalls LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, S
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 29, 2023DrugsFDA
Cardinal Health Inc. recalls LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, St
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 29, 2023DrugsFDA
Cardinal Health Inc. recalls LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Dist
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 29, 2023DrugsFDA
Cardinal Health Inc. recalls LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 29, 2023DrugsFDA
Cardinal Health Inc. recalls LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
December 14, 2022Medical DevicesFDA
Cardinal Health recalls Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag P
Hazard: 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
December 14, 2022Medical DevicesFDA
Cardinal Health recalls Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag P
Hazard: 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
December 14, 2022Medical DevicesFDA
Cardinal Health recalls Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a
Hazard: 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
December 14, 2022Medical DevicesFDA
Cardinal Health recalls Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended fo
Hazard: 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
December 14, 2022Medical DevicesFDA
Cardinal Health recalls Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for
Hazard: 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
December 14, 2022Medical DevicesFDA
Cardinal Health recalls Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary
Hazard: 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
May 25, 2022DrugsFDA
Cardinal Health Inc. recalls Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, India
Hazard: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
May 25, 2022DrugsFDA
Cardinal Health Inc. recalls Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indiana
Hazard: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
May 25, 2022DrugsFDA
Cardinal Health Inc. recalls Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA
Hazard: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
December 22, 2021Medical DevicesFDA
Cardinal Health recalls RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Hazard: Potential for open packaging seals compromising the sterility of the surgical gowns
December 22, 2021Medical DevicesFDA
Cardinal Health recalls RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
Hazard: Potential for open packaging seals compromising the sterility of the surgical gowns
December 22, 2021Medical DevicesFDA
Cardinal Health recalls RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Hazard: Potential for open packaging seals compromising the sterility of the surgical gowns
December 22, 2021Medical DevicesFDA
Cardinal Health recalls RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Hazard: Potential for open packaging seals compromising the sterility of the surgical gowns
December 22, 2021Medical DevicesFDA
Cardinal Health recalls Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
Hazard: Potential for open packaging seals compromising the sterility of the surgical gowns
December 22, 2021Medical DevicesFDA
Cardinal Health recalls Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
Hazard: Potential for open packaging seals compromising the sterility of the surgical gowns
December 22, 2021Medical DevicesFDA
Cardinal Health recalls Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Hazard: Potential for open packaging seals compromising the sterility of the surgical gowns
December 22, 2021Medical DevicesFDA
Cardinal Health recalls SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Hazard: Potential for open packaging seals compromising the sterility of the surgical gowns
December 22, 2021Medical DevicesFDA
Cardinal Health recalls SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
Hazard: Potential for open packaging seals compromising the sterility of the surgical gowns
December 22, 2021Medical DevicesFDA
Cardinal Health recalls SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Hazard: Potential for open packaging seals compromising the sterility of the surgical gowns