DL DrugLabelsHubFDA Drug Label Lookup

FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets. Rx only NDC 0006-0335-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08880, USA Cardinal Health Inc. Class II Terminated 20210602
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 Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA Cardinal Health Inc. Class II Terminated 20210602
PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA Cardinal Health Inc. Class II Terminated 20210602
CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-01; RX; TABLETS Cardinal Health Inc. Class II Terminated 20210602
VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS Cardinal Health Inc. Class II Terminated 20210602
BENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUID Cardinal Health Inc. Class II Terminated 20210602
DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENT Cardinal Health Inc. Class II Terminated 20210602
VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS Cardinal Health Inc. Class II Terminated 20210602
VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS Cardinal Health Inc. Class II Terminated 20210602
VITAMIN D3 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAP Cardinal Health Inc. Class II Terminated 20210602
Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories 31778 Enterprise Drive, Livonia, MI 48150 Cardinal Health Inc. Class II Terminated 20210602
Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA Cardinal Health Inc. Class II Terminated 20210602
MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM Cardinal Health Inc. Class II Terminated 20210602
TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETS Cardinal Health Inc. Class II Terminated 20210602
Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India Cardinal Health Inc. Class II Terminated 20210602
TRI-LO-MARZIA 0.180MG/0.025MG; 0.215 MG/0.025MG AND 0.250MG/0.025MG 3X28 BPK; NDC/UPC 68180-837-73; RX; TABLETS Cardinal Health Inc. Class II Terminated 20210602
NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046 Cardinal Health Inc. Class II Terminated 20210602
Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA Cardinal Health Inc. Class II Terminated 20210602
SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID Cardinal Health Inc. Class II Terminated 20210602
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 Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA Cardinal Health Inc. Class II Terminated 20210602
Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA Cardinal Health Inc. Class II Terminated 20210602
PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES Cardinal Health Inc. Class II Terminated 20210602
PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES Cardinal Health Inc. Class II Terminated 20210602
Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd Nagoya 462-0024 Japan Cardinal Health Inc. Class II Terminated 20210602
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 USA Cardinal Health Inc. Class II Terminated 20210602
INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES Cardinal Health Inc. Class II Terminated 20210602
Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20 Cardinal Health Inc. Class II Terminated 20210602
Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650-30 Manufactured for: JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584 Cardinal Health Inc. Class II Terminated 20210602
TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES Cardinal Health Inc. Class II Terminated 20210602
Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC 0143-9721-24 West-Ward Pharmaceutical Corp Eatontown, NJ 07724 USA Cardinal Health Inc. Class II Terminated 20210602
LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS Cardinal Health Inc. Class II Terminated 20210602
LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES Cardinal Health Inc. Class II Terminated 20210602
Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 Cardinal Health Inc. Class II Terminated 20210602
AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 Cardinal Health Inc. Class II Terminated 20210602
bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 Cardinal Health Inc. Class II Terminated 20210602
FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement 100 Tablets Distributed by: H2-Pharma, LLC 2010 Berry Chase Place Montgomery, AL 36117 Cardinal Health Inc. Class II Terminated 20210602
Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28902 Cardinal Health Inc. Class II Terminated 20210602
Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Healthcare Research Triangle Park, NC 27709 by GlaxoSmithKline Research Triangle Park, NC 27709 Cardinal Health Inc. Class II Terminated 20210602
Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Cardinal Health Inc. Class II Terminated 20210602
EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS Cardinal Health Inc. Class II Terminated 20210602
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., USA Mahwah, NJ 07430 Cardinal Health Inc. Class II Terminated 20210602
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 GlaxoSmithKline Research Triangle Park, NC 27709 Cardinal Health Inc. Class II Terminated 20210602
TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL Cardinal Health Inc. Class II Terminated 20210602
Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0876-10 GlaxoSmithKline Research Triangle Park, NC 27709 Cardinal Health Inc. Class II Terminated 20210602
ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL Cardinal Health Inc. Class II Terminated 20210602
ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL Cardinal Health Inc. Class II Terminated 20210602
FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL Cardinal Health Inc. Class II Terminated 20210602
cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech Cardinal Health Inc. Class II Terminated 20210602
Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals Cardinal Health Inc. Class II Terminated 20210602
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP Cardinal Health Inc. Class II Terminated 20210602