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

ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

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

Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By Perrigo Allegan, MI 49010

March 15, 2021 Cardinal Health Inc. 321 bottles units
FDA Drug Class II Terminated

GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL

March 15, 2021 Cardinal Health Inc. 3 CARTON units
FDA Drug Class II Terminated

Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650-30 Manufactured for: JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584

March 15, 2021 Cardinal Health Inc. 11 bottles units
FDA Drug Class II Terminated

BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS

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

Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9

March 15, 2021 Cardinal Health Inc. 38 bottles units
FDA Drug Class II Terminated

PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA

March 15, 2021 Cardinal Health Inc. 147 units
FDA Drug Class II Terminated

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: Glen

March 15, 2021 Cardinal Health Inc. 141 bottles units
FDA Drug Class II Terminated

Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 tablets each, Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 055

March 15, 2021 Cardinal Health Inc. 23 bottles units
FDA Drug Class II Terminated

HYDROCORTISONE 1% 30gm cream

March 15, 2021 Cardinal Health Inc. 143 tubes units
FDA Drug Class II Terminated

Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland

March 15, 2021 Cardinal Health Inc. 13 packets units
FDA Drug Class II Terminated

Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00

March 15, 2021 Cardinal Health Inc. 271 bottles units
FDA Drug Class II Terminated

TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS

March 15, 2021 Cardinal Health Inc. 325 CARTONS units
FDA Drug Class II Terminated

Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rock

March 15, 2021 Cardinal Health Inc. 490 bottles units
FDA Drug Class II Terminated

TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT

March 15, 2021 Cardinal Health Inc. 28 tubes units
FDA Drug Class II Terminated

Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432

March 15, 2021 Cardinal Health Inc. 1 bottle units
FDA Drug Class II Terminated

PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73

March 15, 2021 Cardinal Health Inc. 91 bottles units
FDA Drug Class II Terminated

BENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUID

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

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

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

Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL

March 15, 2021 Cardinal Health Inc. 123 bottles units
FDA Drug Class II Terminated

SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 67 BOXES units
FDA Drug Class II Terminated

BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM NDC/UPC 47781-0356-03; RX; FILM

March 15, 2021 Cardinal Health Inc. 249 CARTONS units
FDA Drug Class II Terminated

COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solut

March 15, 2021 Cardinal Health Inc. 12 bottles units
FDA Drug Class II Terminated

Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 inhalations Rx Only NDC 0310-4600-12 Mfd for: AstraZeneca Pharm

March 15, 2021 Cardinal Health Inc. 355 inhalers units
FDA Drug Class II Terminated

VITAMIN D3 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAP

March 15, 2021 Cardinal Health Inc. 380 BOTTLE units
FDA Drug Class II Terminated

Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

March 15, 2021 Cardinal Health Inc. 112 bottles units
FDA Drug Class II Terminated

Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA

March 15, 2021 Cardinal Health Inc. 88 bottles units
FDA Drug Class II Terminated

Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation Aerosol 120 inhalations Rx only Manufactured for: AstraZeneca

March 15, 2021 Cardinal Health Inc. 905 inhalers units
FDA Drug Class II Terminated

Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules Rx Only NDC 13811-539-90 Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872

March 15, 2021 Cardinal Health Inc. 80 bottles units
FDA Drug Class II Terminated

Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary Supplements Carefully Designed and Distributed by Nature's Truth LLC. Ronkonkoma, NY 11779, UPC 840093100672

March 15, 2021 Cardinal Health Inc. 8 bottles units
FDA Drug Class II Terminated

CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75; RX; DROPS

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

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

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

Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield

March 15, 2021 Cardinal Health Inc. 269 bottles units
FDA Drug Class II Terminated

Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A

March 15, 2021 Cardinal Health Inc. 1189 cartons units
FDA Drug Class II Terminated

Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134

March 15, 2021 Cardinal Health Inc. 348 droptainers units
FDA Drug Class II Terminated

Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054

March 15, 2021 Cardinal Health Inc. 759 bottles units
FDA Drug Class II Terminated

EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC

March 15, 2021 Cardinal Health Inc. 1776 boxes units
FDA Drug Class II Terminated

LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01

March 15, 2021 Cardinal Health Inc. 13 bottles units
FDA Drug Class II Terminated

Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01

March 15, 2021 Cardinal Health Inc. 620 injector units
FDA Drug Class II Terminated

BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS

March 15, 2021 Cardinal Health Inc. 152 CARTON units
FDA Drug Class II Terminated

ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

March 15, 2021 Cardinal Health Inc. 667 inhalers units
FDA Drug Class II Terminated

MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS

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

Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017

March 15, 2021 Cardinal Health Inc. 940 cartons units
FDA Drug Class II Terminated

Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

March 15, 2021 Cardinal Health Inc. 72 cartons units
FDA Drug Class II Terminated

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

March 15, 2021 Cardinal Health Inc. 299 cartons units
FDA Drug Class II Terminated

Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada

March 15, 2021 Cardinal Health Inc. 255 bottles units
FDA Drug Class II Terminated

EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 00

March 15, 2021 Cardinal Health Inc. 414 boxes units
FDA Drug Class II Terminated

Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS

March 15, 2021 Cardinal Health Inc. 1371 bottles units
FDA Drug Class II Terminated

VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35

March 15, 2021 Cardinal Health Inc. 882 bottles units
FDA Drug Class II Terminated

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 US

March 15, 2021 Cardinal Health Inc. 453 bottles units