Cardinal Health Inc.

Complete recall history across all FDA and CPSC categories — 240 total recalls

Cardinal Health Inc. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (213)

FDA drug safety enforcement actions by Cardinal Health Inc.. Showing most recent 50.

Date Product Reason Class
Aug 5, 2025 Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled ... Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection... Class II
Jul 30, 2025 Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech... CGMP Deviations - Product was exposed to temperatures outside the product's l... Class II
Jul 30, 2025 Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South ... CGMP Deviations - Product was exposed to temperatures outside the product's l... Class II
Jul 30, 2025 RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Take... CGMP Deviations - Product was exposed to temperatures outside the product's l... Class II
Apr 9, 2025 Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens ... Temperature abuse: Wegovy product was potentially exposed to temperatures out... Class II
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 F... Non-Sterility: FDA found insanitary conditions and positive bacterial test re... Class I
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL)... Non-Sterility: FDA found insanitary conditions and positive bacterial test re... Class I
Oct 31, 2023 LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (1... Non-Sterility: FDA found insanitary conditions and positive bacterial test re... Class I
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bot... Non-Sterility: FDA found insanitary conditions and positive bacterial test re... Class I
Oct 31, 2023 LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... Non-Sterility: FDA found insanitary conditions and positive bacterial test re... Class I
Oct 31, 2023 LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, ... Non-Sterility: FDA found insanitary conditions and positive bacterial test re... Class I
Apr 5, 2022 Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pe... TEMPERATURE ABUSE: Products were exposed to temperatures outside of the produ... Class II
Apr 5, 2022 Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Pr... TEMPERATURE ABUSE: Products were exposed to temperatures outside of the produ... Class I
Apr 5, 2022 Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose P... TEMPERATURE ABUSE: Products were exposed to temperatures outside of the produ... Class II
Mar 15, 2021 Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bo... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only ND... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Man... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With D... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured und... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured f... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (A... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. T... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/d... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Wee... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfize... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx onl... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg sema... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tabl... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietar... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplemen... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufact... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budeso... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II
Mar 15, 2021 Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II

View all 213 drug recalls →

Device Recalls (27)

FDA medical device enforcement actions by Cardinal Health Inc.

Date Product Reason Class
Mar 16, 2021 ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 FREESTYLE LANCETS 28G 100CT Item Number:2975670 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 BD UF PEN 32GX4MM 100 NANO Item Number: 4292272 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 VAPORIZER VICKS 1.5GAL Item Number: 2354942 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 DEXCOM G6 SENSOR 3 PACK Item Number: 5447552 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Mar 16, 2021 OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326 Due to shipping delays the devices were exposed to temperature excursions of ... Class II
Apr 20, 2020 Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product ... Three products requiring refrigerated storage conditions were incorrectly sto... Class II
Apr 20, 2020 B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is... Three products requiring refrigerated storage conditions were incorrectly sto... Class II
Apr 20, 2020 Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere P... Three products requiring refrigerated storage conditions were incorrectly sto... Class II
Dec 26, 2019 Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659 The feeding spike sets may leak at the interface of the tube and spike connec... Class II
Dec 26, 2019 Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559 The feeding spike sets may leak at the interface of the tube and spike connec... Class II
Dec 26, 2019 Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Prod... The feeding spike sets may leak at the interface of the tube and spike connec... Class II
Dec 26, 2019 Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Pr... The feeding spike sets may leak at the interface of the tube and spike connec... Class II
Dec 26, 2019 Kangaroo 924 Safety Screw Spike Set, Product Code 775759 The feeding spike sets may leak at the interface of the tube and spike connec... Class II
Dec 26, 2019 Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD The feeding spike sets may leak at the interface of the tube and spike connec... Class II
Nov 14, 2019 Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.... Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents ... Class II
Nov 14, 2019 S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent Syst... Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents ... Class II
Nov 14, 2019 Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent Sys... Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents ... Class II
Nov 16, 2018 Presource Kit Total Joint Pack containing a double-wrapped basin component. ... The double wrapping of this custom kit basin set is not supported by the curr... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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