Product Recalls in 2021

3,955 recalls issued this year

219

CPSC

1,491

FDA Food

1,152

FDA Drug

1,093

NHTSA

NHTSA Ongoing

Head-Thorax Air Bag May Not Deploy Correctly

March 16, 2021 BMW OF NORTH AMERICA, LLC 1,850 units
FDA Food Class II Terminated

EL Sembrador MIxed vegetables, Poly bags, 12/ 32 oz.

March 16, 2021 Bonduelle USA Inc. 123 cases units
FDA Food Class II Terminated

El Sembrador Peas and Carrots, poly bags, 12/16 oz

March 16, 2021 Bonduelle USA Inc. 104 cases units
FDA Drug Class II Terminated

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

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

LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS

March 15, 2021 Cardinal Health Inc. 2854 bottles units
FDA Drug Class II Terminated

Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328

March 15, 2021 Cardinal Health Inc. 328 bottles units
FDA Drug Class II Terminated

xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by

March 15, 2021 Cardinal Health Inc. 664 bottles units
FDA Drug Class II Terminated

Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612

March 15, 2021 Cardinal Health Inc. 96 cartons units
FDA Drug Class II Terminated

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

March 15, 2021 Cardinal Health Inc. 422 bottles units
FDA Drug Class II Terminated

NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS

March 15, 2021 Cardinal Health Inc. 4 bottles units
FDA Drug Class II Terminated

NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)

March 15, 2021 Cardinal Health Inc. 1240 CARTON units
FDA Drug Class II Terminated

EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 7 CARTON units
FDA Drug Class II Terminated

Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110

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

The Toasted Oat Bakehouse Blueberry Cobbler Soft Granola (6 -10 oz pouches per case); and Soft Granola Crumble Bars Blueberry Cobbler (5 - 28.3g bars per pack/6 packs per case)

March 15, 2021 The Toasted Oat 145,000 (total of 28.3g bars); 87905 (total of 10oz Pouches) units
FDA Drug Class II Terminated

Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10 Distributed by: Meda Pharmaceutical Inc. Somerset, New Jersey

March 15, 2021 Cardinal Health Inc. 834 aerosol containers units
FDA Drug Class II Terminated

Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612

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

MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM

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

Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36

March 15, 2021 Cardinal Health Inc. 178 tubes units
FDA Drug Class II Terminated

PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16

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

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 R

March 15, 2021 Cardinal Health Inc. 2264 bottles units
FDA Drug Class II Terminated

medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02

March 15, 2021 Cardinal Health Inc. 148 syringes units
FDA Drug Class II Terminated

CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES

March 15, 2021 Cardinal Health Inc. 17 patches units
FDA Drug Class II Terminated

ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 1935 bottles units
FDA Drug Class II Terminated

UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 964 bottles units
FDA Drug Class II Terminated

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

March 15, 2021 Cardinal Health Inc. 4065 CARTON units
FDA Drug Class II Terminated

Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec City, Canada, G1V 4M7 Distributed by: AMAG Pharmaceuticals, Inc. Waltam, MA 02451,

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

Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe Rx only NDC 59762-4538-2 Distributed by: Greenstone, LLC. Peapack, NJ 07977

March 15, 2021 Cardinal Health Inc. 286 syringes units
FDA Drug Class II Terminated

Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520

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

PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES

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

Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Lt

March 15, 2021 Sun Pharmaceutical Industries Inc. 91,211 syringes units
FDA Drug Class II Terminated

LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS

March 15, 2021 Cardinal Health Inc. 12 bottles units
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

TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10

March 15, 2021 Cardinal Health Inc. 86 BOTTLE 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

HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076

March 15, 2021 Cardinal Health Inc. 236 bottles 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