Cardinal Health Inc. Provisional
FDA Flags (14)
Class II RecallSep 2025
Cardinal Health Inc.
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 pref
Classification: Class II
Class II RecallAug 2025
Cardinal Health Inc.
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142
Classification: Class II
Class II RecallAug 2025
Cardinal Health Inc.
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Classification: Class II
Class II RecallAug 2025
Cardinal Health Inc.
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 5
Classification: Class II
Class II RecallMay 2025
Cardinal Health Inc.
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx O
Classification: Class II
Class I RecallNov 2023
Cardinal Health Inc.
LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, S
Classification: Class I
Class I RecallNov 2023
Cardinal Health Inc.
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL
Classification: Class I
Class I RecallNov 2023
Cardinal Health Inc.
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, St
Classification: Class I
Class I RecallNov 2023
Cardinal Health Inc.
LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed
Classification: Class I
Class I RecallNov 2023
Cardinal Health Inc.
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By
Classification: Class I
Class I RecallNov 2023
Cardinal Health Inc.
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Dist
Classification: Class I
Class II RecallMay 2022
Cardinal Health Inc.
Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, India
Classification: Class II
Class I RecallMay 2022
Cardinal Health Inc.
Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA
Classification: Class I
Class II RecallMay 2022
Cardinal Health Inc.
Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indiana
Classification: Class II