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

RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX

March 15, 2021 Cardinal Health Inc. 3688 bottles units
FDA Drug Class II Terminated

Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532

March 15, 2021 Cardinal Health Inc. 2907 bottles units
FDA Drug Class II Terminated

Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677

March 15, 2021 Cardinal Health Inc. 30 bottles units
FDA Drug Class II Terminated

PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES

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

OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS

March 15, 2021 Cardinal Health Inc. 339 bottles units
FDA Drug Class II Terminated

Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA

March 15, 2021 Cardinal Health Inc. 205 bottles units
FDA Drug Class II Terminated

ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 29 bottles units
FDA Drug Class II Terminated

Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India

March 15, 2021 Cardinal Health Inc. 20 bottles units
FDA Drug Class II Terminated

Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30

March 15, 2021 Cardinal Health Inc. 1391 tubes units
FDA Drug Class II Terminated

Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01

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

LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORE

March 15, 2021 Cardinal Health Inc. 49 bottles units
FDA Drug Class II Terminated

Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036

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

VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS

March 15, 2021 Cardinal Health Inc. 427 BOTTLE units
FDA Drug Class II Terminated

Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13

March 15, 2021 Cardinal Health Inc. 52 bottles units
FDA Food Class I Terminated

Nuts.com brand Diced Dried Figs packaged in 1lb stand up gusset pouches.

March 15, 2021 Nuts.com 20 lbs units
FDA Drug Class II Terminated

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 Montgo

March 15, 2021 Cardinal Health Inc. 54 bottles units
FDA Drug Class II Terminated

bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

March 15, 2021 Cardinal Health Inc. 32 bottles units
FDA Drug Class II Terminated

Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A.

March 15, 2021 Cardinal Health Inc. 1669 bottles units
FDA Drug Class II Terminated

ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

March 15, 2021 Cardinal Health Inc. 297 inhalers units
FDA Drug Class II Terminated

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not for Household Use Rx Only NDC 60432-275-16 Distributed By: W

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

Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

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

Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612

March 15, 2021 Cardinal Health Inc. 1529 bottles units
FDA Drug Class II Terminated

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP

March 15, 2021 Cardinal Health Inc. 73 carton units
FDA Drug Class II Terminated

Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution) Rx Only NDC 47781-384-26 Distributed by: Alvoge

March 15, 2021 Cardinal Health Inc. 15885 bottles units
FDA Drug Class II Terminated

INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60

March 15, 2021 Cardinal Health Inc. 32 bottles units
FDA Drug Class II Terminated

CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-01; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 407 BOXES units
FDA Drug Class II Terminated

TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETS

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

LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)

March 15, 2021 Cardinal Health Inc. 240 bottles units
FDA Drug Class II Terminated

TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS

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

Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70

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

Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals

March 15, 2021 Cardinal Health Inc. 41 bottles units
FDA Drug Class II Terminated

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 L

March 15, 2021 Cardinal Health Inc. 33 bottles units
FDA Drug Class II Terminated

RISPERIDONE 1MG/ML 30ML; NDC/UPC 50458059601; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)

March 15, 2021 Cardinal Health Inc. 39 bottles units
NHTSA Ongoing

Steering Arm May Detach

March 15, 2021 DEXTER AXLE COMPANY 1,238 units
FDA Drug Class II Terminated

edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 T

March 15, 2021 Cardinal Health Inc. 273 bottles units
FDA Drug Class II Terminated

CIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK)

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

cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech

March 15, 2021 Cardinal Health Inc. 1473 vials units
FDA Drug Class II Terminated

PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS

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

Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66

March 15, 2021 Cardinal Health Inc. 101 bottles units
FDA Drug Class II Terminated

NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046

March 15, 2021 Cardinal Health Inc. 24 bottles units
FDA Drug Class II Terminated

NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01

March 15, 2021 Cardinal Health Inc. 41 bottles units
FDA Drug Class II Terminated

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 RX; TABLETS

March 15, 2021 Cardinal Health Inc. 235 bottles units
FDA Drug Class II Terminated

Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye Rx Only NDC 60505-1005-4 Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for:

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

Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

March 15, 2021 Cardinal Health Inc. 592 bottles units
FDA Drug Class II Terminated

AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 373 bottles units
FDA Drug Class II Terminated

ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 135 CARTON units
FDA Drug Class II Terminated

POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (17g) each NDC 45802-868-66

March 15, 2021 Cardinal Health Inc. 934 boxes units
FDA Drug Class II Terminated

Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21

March 15, 2021 Cardinal Health Inc. 406 vials units
FDA Drug Class II Terminated

Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336

March 15, 2021 Cardinal Health Inc. 504 cartons units
FDA Drug Class II Terminated

Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by Perrigo, Minneapolis, MN 55427, NDC 0574-0611-05.

March 15, 2021 Cardinal Health Inc. 180 bottles units