Cardinal Health Inc.

Dublin, OH, United States

213

Total Recalls

7

Class I Recalls

11

Ongoing Recalls

Recalls by Cardinal Health Inc.

FDA Drug Class II Terminated

Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 1

March 15, 2021 Cardinal Health Inc. 37 bottles units
FDA Drug Class II Terminated

Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 US

March 15, 2021 Cardinal Health Inc. 284 bottles units
FDA Drug Class II Terminated

xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850

March 15, 2021 Cardinal Health Inc. 378 bottles units
FDA Drug Class II Terminated

DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS

March 15, 2021 Cardinal Health Inc. 318 droptainers units
FDA Drug Class II Terminated

LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES

March 15, 2021 Cardinal Health Inc. 298 bottles units
FDA Drug Class II Terminated

FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES

March 15, 2021 Cardinal Health Inc. 106 BOXES units
FDA Drug Class II Terminated

METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 51 bottles units
FDA Drug Class II Terminated

VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS

March 15, 2021 Cardinal Health Inc. 53 BOTTLE units
FDA Drug Class II Terminated

Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA

March 15, 2021 Cardinal Health Inc. 71 bottles units
FDA Drug Class II Terminated

Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, IL 60045. NDC 61703-350-38.

March 15, 2021 Cardinal Health Inc. 341 vials units
FDA Drug Class II Terminated

Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850

March 15, 2021 Cardinal Health Inc. 1278 bottles units
FDA Drug Class II Terminated

LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL

March 15, 2021 Cardinal Health Inc. 463 boxes units
FDA Drug Class II Terminated

Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 Manufactured by: Boehringer Ingelheim (BI) Pharma GmbH &

March 15, 2021 Cardinal Health Inc. 2611 inhalers units
FDA Drug Class II Terminated

Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20

March 15, 2021 Cardinal Health Inc. 37 bottles units
FDA Drug Class II Terminated

Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each week

March 15, 2021 Cardinal Health Inc. 210 cartons units
FDA Drug Class II Terminated

edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328

March 15, 2021 Cardinal Health Inc. 244 bottles units
FDA Drug Class II Terminated

Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets Rx only NDC 00006-0033-30 Merck

March 15, 2021 Cardinal Health Inc. 119 cartons units
FDA Drug Class II Terminated

Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefie

March 15, 2021 Cardinal Health Inc. 751 bottles units
FDA Drug Class II Terminated

Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manufactured by: Glenmark Generics Ltd Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Generics Inc.,

March 15, 2021 Cardinal Health Inc. 513 bottles units
FDA Drug Class II Terminated

HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11

March 15, 2021 Cardinal Health Inc. 35 BOTTLE units
FDA Drug Class II Terminated

BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 75 bottles units
FDA Drug Class II Terminated

ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET

March 15, 2021 Cardinal Health Inc. 55 Boxes units
FDA Drug Class II Terminated

Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield,

March 15, 2021 Cardinal Health Inc. 52 bottles units
FDA Drug Class II Terminated

FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

March 15, 2021 Cardinal Health Inc. 237 inhalers units
FDA Drug Class II Terminated

ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

March 15, 2021 Cardinal Health Inc. 122 inhalers units
FDA Drug Class II Terminated

Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Akorn, Inc.

March 15, 2021 Cardinal Health Inc. 424 bottles units
FDA Drug Class II Terminated

THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS

March 15, 2021 Cardinal Health Inc. 55 bottles units
FDA Drug Class II Terminated

Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceu

March 15, 2021 Cardinal Health Inc. 357 bottles units
FDA Drug Class II Terminated

Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30 Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Pars

March 15, 2021 Cardinal Health Inc. 57 bottles units
FDA Drug Class II Terminated

HYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, Allegan, MI 49010, NDC: 0574-7093-12

March 15, 2021 Cardinal Health Inc. 95 suppositories units
FDA Drug Class II Terminated

Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, I

March 15, 2021 Cardinal Health Inc. 1040 cartons units
FDA Drug Class II Terminated

AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

March 15, 2021 Cardinal Health Inc. 122 bottles units
FDA Drug Class II Terminated

Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241

March 15, 2021 Cardinal Health Inc. 2 bottles units
FDA Drug Class II Terminated

Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.

March 15, 2021 Cardinal Health Inc. 15 bottles units
FDA Drug Class II Terminated

PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES

March 15, 2021 Cardinal Health Inc. 16 bottles units
FDA Drug Class II Terminated

Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla USA Inc. 9100 S. Dadeland Blvd., Suite 1599 Miami, FL 33156

March 15, 2021 Cardinal Health Inc. 40 bottles units
FDA Drug Class II Terminated

Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02

March 15, 2021 Cardinal Health Inc. 10 bottles units
FDA Drug Class II Terminated

Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156

March 15, 2021 Cardinal Health Inc. 576 bottles units
FDA Drug Class II Terminated

ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES

March 15, 2021 Cardinal Health Inc. 64 BOXES units
FDA Drug Class II Terminated

Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

March 15, 2021 Cardinal Health Inc. 215 bottles units
FDA Drug Class II Terminated

DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENT

March 15, 2021 Cardinal Health Inc. 701 CARTON units
FDA Drug Class II Terminated

VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080

March 15, 2021 Cardinal Health Inc. 796 bottles units
FDA Drug Class II Terminated

Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray. 0.1 mL intranasal spray per unit For use in the nose only Rx only NDC 695

March 15, 2021 Cardinal Health Inc. 11189 plungers units
FDA Drug Class II Terminated

Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler containing 30 doses (60 blisters total) Rx Only NDC 0173-0887-10 GlaxoS

March 15, 2021 Cardinal Health Inc. 903 inhalers units
FDA Drug Class II Terminated

Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc. 750 Lexington Avenue, 20th Floor New York, NY 10022 US

March 15, 2021 Cardinal Health Inc. 136 bottles units
FDA Drug Class II Terminated

Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811

March 15, 2021 Cardinal Health Inc. 60 bottles units
FDA Drug Class II Terminated

Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

March 15, 2021 Cardinal Health Inc. 828 inhalers units
FDA Drug Class II Terminated

Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612

March 15, 2021 Cardinal Health Inc. 47 cartons units
FDA Drug Class II Terminated

Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma, LLC, Laurelton, NY 11413, NDC 42806-011-01

March 15, 2021 Cardinal Health Inc. 92 bottles units
FDA Drug Class II Terminated

VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS

March 15, 2021 Cardinal Health Inc. 19 BOTTLE units