Cardinal Health recalls
FDA enforcement reports naming Cardinal Health as the recalling firm.
- Recall reports
- 215
- Class I (serious)
- 7
- Most recent report
- Sep 3, 2025
- Sep 3, 2025Enoxaparin Sodium Injection, USP, 30 mg/0Drug · Cardinal Health Inc.Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mLClass II
- Aug 13, 2025Xolair (omalizumab injection), 75 mg/0Drug · Cardinal Health Inc.CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.Class II
- Aug 13, 2025Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, Sou…Drug · Cardinal Health Inc.CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.Class II
- Aug 13, 2025RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmac…Drug · Cardinal Health Inc.CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.Class II
- May 7, 2025Wegovy (semaglutide) injection, 2Drug · Cardinal Health Inc.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, pr…Class II
- Nov 29, 2023LEADER brand Lubricant Eye Drops (Propylene Glycol, 0Drug · Cardinal Health Inc.Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Class I
- Nov 29, 2023LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0Drug · Cardinal Health Inc.Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Class I
- Nov 29, 2023LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0Drug · Cardinal Health Inc.Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Class I
- Nov 29, 2023LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%)Drug · Cardinal Health Inc.Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Class I
- Nov 29, 2023LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0Drug · Cardinal Health Inc.Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.Class I
- LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0
- Trulicity (dulaglutide) injection, 0
- Trulicity (dulaglutide) injection, 1
- Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pe…
- CATAPRES-TTS-2 1X4
- Synjardy (empagliflozin and metformin hydrochloride) Tablets 12
- Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distrib…
- PREGABALIN CAPSULES 300MG 90
- Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4…
- TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62
- Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets…
- LITHIUM CARB 150MG 100
- Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Sil…
- MICONAZOLE 7 2% 45GM APL
- VITAMIN D3 25MCG 90 TABLETS
- Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aeroso…
- Triamcinolone Acetonide Ointment, USP, 0
- Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx…
- PROMETHAZINE PLAIN ORAL SOLUTION 6
- Intrarosa Prasterone Vaginal Inserts 6
- Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syr…
- medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distrib…
- Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories…
- Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrati…
- OFLOXACIN 0
- LIDOCAINE HCL VISC 2% 100ML
- Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile…
- COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hyd…
- BROMFENAC OPHTHALMIC SOLUTION 0
- RESTASIS 0
- Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per ca…
- Rectiv (nitroglycerin) Ointment 0
- Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distribu…
- Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manuf…
- BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLIN…
- Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir b…
- TRAVOPROST OPHTHALMIC SOLUTION, USP 0
- Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2
- Timolol Maleate Ophthalmic Solution, USP 0
- GEMCITABINE INJECTION 200MG/5
- Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4
- BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5
- MURO-128 2% 15ML OPTH
- TOBRAMY/DEX 0
- Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 bucca…
- SYMPROIC (NAIDEMEDINE) TABLETS 0
- ATROVENT HFA 17MCG 12
- Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597…
- Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/…
- Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12
- Sodium Sulfacetamide 9
- Meloxicam Tablets, USP 7
- Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla…
- BENICAR 40MG 30
- Phenobarbital Tablets, USP 32
- Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of…
- BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMI…
- Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant…
- cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech
- ADVAIR HFA 45-21MCG 12GM
- ARNUITY ELLIPTA 100MCG 30INH
- Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler conta…
- Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 1…
- Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Ma…
- Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-…
- Hydrocortisone Ointment USP 1% Maximum Strength Net Wt
- FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2
- bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufac…
- Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for:…
- Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL…
- TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules
- Enbrace HR 30 ct
- INVEGA SUSTENNA 156MG/1ML
- Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Manufactu…
- Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license…
- PHENTERMINE HCL 30MG 100 C4
- Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1
- SILADRYL 12
- Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-18…
- NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl
- TRI-LO-MARZIA 0
- Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-19…
- TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD
- Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distrib…
- Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1
- VITAMIN D3 50MCG 100 SOFTGELS
- VITAMIN D3 25MCG 180 TABLETS
- BENZOYL PEROXIDE WASH 5% 148ML
- VITAMIN D3 50MCG 100 CALC
- CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS
- PEDIA-LAX 66ML
- Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant
- Levothyroxine Sodium Tablets, USP 125 mcg (0
- Estradiol Transdermal System, USP 0
- Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactur…
- NAT B VIT D3 2000U 100
- Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 M…
- Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Ma…
- TOBREX 0
- Ilevro (nepafenac ophthalmic suspension) 0
- CIPRODEX (CIPROFLOXACIN 0
- Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured…
- Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufac…
- ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3
- HySept Solution 0
- RISPERIDONE 1MG/ML 30ML
- Benzoyl Peroxide 2
- Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Al…
- Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4
- POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Pa…
- Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg…
- LORATADINE 10MG 100 ND 24H
- Cetirizine Hydrochloride Tablets, 10 mg, 300 Count
- Podofilox Topical Solution 0
- HYDROCORTISONE ACET 30MG 12
- LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Dav…
- Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x…
- Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x…
- Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0
- LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc
- Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary Suppleme…
- Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4
- Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactur…
- Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Uni…
- CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured…
- COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx O…
- Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufact…
- Colcrys (colchicine, USP) tablets 0
- Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counte…
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2
- PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufact…
- EPINEPHRINE INJECTION USP, 0
- Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations N…
- Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30 Manuf…
- Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma,…
- Darifenacin Extended-release Tablets 7
- Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules…
- TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: R…
- Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supp…
- INTEGRA 325/40/3mg 90-count bottle
- VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle
- Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc
- HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith La…
- Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed b…
- CYANOCOBAL Injection 1000MCG/ML 25X1ML
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromid…
- Enalapril Maleate Tablets, USP 2
- Orilissa elagolix tablets 150 mg per tablet equivalent to 155
- THERAPEUTIC M 130
- Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1…
- edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12
- Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Un…
- METHOCARBAMOL 500MG 500
- FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04
- Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx onl…
- Vaniqa (eflornithine hydrochloride) Cream, 13
- UBRELVY 100MG 10UD CPLT
- ERYTHROMYCIN TABLETS, USP 250MG 30
- Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufac…
- xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablet…
- xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablet…
- ONDANSETRON HCL 4MG 30
- DEXAMETH SOD PHOS 0
- Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 bucca…
- Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Dist…
- Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispen…
- VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc
- HYDROCORTISONE 1% 30gm cream
- Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 7…
- Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upshe…
- Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30…
- NIACIN 250MG 110
- NURTEC ODT (RIMEGEPANT) 75MG 8 BPK
- EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30
- Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant
- LEUCOVORIN 15MG 24
- Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torren…
- Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules…
- EPINEPHRINE INJECTION USP, 0
- PHENTERMINE HCL 37
- LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0
- NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Phar…
- Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 m…
- FLOVENT DISKUS 100MCG 60
- ASMANEX TWST 220MCG 60INH PWD
- AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for…
- ESZOPICLONE 3MG 100 C4
- Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by:…
- Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc
- edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet co…
- CIPROFLOX/D5W 400/200 24X200ML
- AMOXICILLIN 500MG 100
- ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES
- Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf
- DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM
- IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML
- Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor…
- Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by…
- Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-6…
- Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20…
- Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd
- PRAVACHOL 40MG 90
- Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton…
- Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of…
- Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackag…
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