Product Recalls in 2021

3,955 recalls issued this year

219

CPSC

1,491

FDA Food

1,152

FDA Drug

1,093

NHTSA

FDA Drug Class II Terminated

Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07

March 15, 2021 Cardinal Health Inc. 160 bottles units
FDA Drug Class II Terminated

Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827

March 15, 2021 Cardinal Health Inc. 523 bottles 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

Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-01 Distributed by Perrigo Allegan, MI 49010

March 15, 2021 Cardinal Health Inc. 163 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
NHTSA Ongoing

Asphyxiation Danger Warning Label Missing

March 15, 2021 LGS Industries Inc 60 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
FDA Drug Class II Terminated

Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc.

March 15, 2021 Cardinal Health Inc. 31 tubes units
FDA Drug Class II Terminated

INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES

March 15, 2021 Cardinal Health Inc. 534 syringes units
FDA Drug Class II Terminated

Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Zhejiang 317024 China For Par Pharmaceutical Companes, Inc. Sp

March 15, 2021 Cardinal Health Inc. 131 bottles units
FDA Drug Class II Terminated

Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A.

March 15, 2021 Cardinal Health Inc. 362 bottles units
FDA Drug Class II Terminated

Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-5

March 15, 2021 Cardinal Health Inc. 848 bottles units
FDA Drug Class II Terminated

Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC 50096-502-10 Manufactured for: Rosemar Labs, LLC 2100 West Loop South Su

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

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

March 15, 2021 Cardinal Health Inc. 353 inhalers units
FDA Drug Class II Terminated

IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS)

March 15, 2021 Cardinal Health Inc. 345 CARTONS units
FDA Drug Class II Terminated

SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID

March 15, 2021 Cardinal Health Inc. 78 bottles units
FDA Drug Class II Terminated

CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIAL

March 15, 2021 Cardinal Health Inc. 6 boxes units
FDA Drug Class II Terminated

TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES

March 15, 2021 Cardinal Health Inc. 25 boxes units
FDA Drug Class II Terminated

Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) NDC 45802-101-96 Distributed By Perrigo Allegan, MI 49010

March 15, 2021 Cardinal Health Inc. 5 tubes units
FDA Drug Class II Terminated

NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS

March 15, 2021 Cardinal Health Inc. 47 bottles units