Product Recalls in 2020

3,187 recalls issued this year

257

CPSC

1,117

FDA Food

930

FDA Drug

883

NHTSA

CPSC Ongoing

Kawasaki USA Recalls Off-Highway Utility Vehicles Due to Fuel Leak, Fire Hazards (Recall Alert)

March 19, 2020 Kawasaki Motors Manufacturing Corp., U.S.A., of Lincoln, Neb. About 72,000 units
FDA Drug Class II Terminated

Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01

March 18, 2020 Aurobindo Pharma USA Inc 14707 units units
NHTSA Ongoing

Doors May Not Open From The Inside

March 18, 2020 Lamborghini (Automobili Lamborghini) 26 units
NHTSA Ongoing

Improperly Tightened Instrument Panel Casing

March 18, 2020 BMW OF NORTH AMERICA, LLC 15 units
FDA Drug Class II Terminated

Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34

March 18, 2020 Aurobindo Pharma USA Inc 56208 units units
FDA Drug Class II Terminated

Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90

March 18, 2020 Aurobindo Pharma USA Inc 26976 units units
CPSC Ongoing

Belle Chemical Recalls Drain Cleaner Product Due to Violation of FHSA Labeling Requirement

March 18, 2020 Belle Chemical, of Billings, Mont. About 6,400 units
FDA Drug Class II Terminated

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99

March 18, 2020 Aurobindo Pharma USA Inc 4332 units units
FDA Drug Class II Terminated

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01

March 18, 2020 Aurobindo Pharma USA Inc 14194 units units
FDA Drug Class II Terminated

Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99

March 18, 2020 Aurobindo Pharma USA Inc 26625 units units
FDA Food Class II Terminated

Aseltines 100% JUICE Apple Cider 1/2 gallon UPC 5169600064 and 1 gallon UPC 5169600128

March 18, 2020 Aseltines 3816 1/2 gallons and 3576 gallons units
FDA Drug Class II Terminated

Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08

March 18, 2020 Aurobindo Pharma USA Inc 8040 units units
CPSC Ongoing

Earthroma Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

March 18, 2020 Earthroma LLC, of Fayetteville, Arkansas About 140 units
FDA Food Class II Terminated

Lindt & Sprungli (USA), Inc.; Excellence 85% Cocoa Dark Chocolate; Net WT 3.5OZ (100g)

March 18, 2020 Lindt & Sprungli (USA), Inc. 174,288 bars (1210 cases) units
FDA Drug Class II Terminated

Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01

March 18, 2020 Aurobindo Pharma USA Inc 2101 units units
CPSC Ongoing

Earth Sonnets Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

March 18, 2020 Butterfly Express, of Clifton, Idaho About 20 units
CPSC Ongoing

Boyer Recalls Six Brands of Sodium and Potassium Hydroxide Due to Failure to Meet Child-Resistant Packaging Requirement; Injuries Reported

March 18, 2020 The Boyer Corporation Inc., LaGrange, Ill. About 329,000 units
CPSC Ongoing

NumbSkin Pain Relief Cream Recalled by SeeNext Venture Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

March 18, 2020 About 8,000 units
FDA Drug Class II Terminated

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01

March 18, 2020 Aurobindo Pharma USA Inc 57337 units units
CPSC Ongoing

Belle Chemical Recalls Sodium Hydroxide and Potassium Hydroxide Products Due to Failure to Meet Child-Resistant Packaging Requirement and Violation of FHSA Labeling Requirement

March 18, 2020 Belle Chemical, of Billings, Mont. About 103,000 units
CPSC Ongoing

Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning

March 18, 2020 About 73,000 units
NHTSA Ongoing

Shifter Cable May Disconnect from Transmission

March 17, 2020 THOR MOTOR COACH 227 units
CPSC Ongoing

American Honda Recall of Portable Generators Due to Fire and Burn Hazards

March 17, 2020 About 340,000 (about 200,000 units were previously recalled in 2019) units
NHTSA Ongoing

Front Brake Hose may be Improperly Routed

March 17, 2020 TRIUMPH MOTORCYCLES (AMERICA) LTD 1,585 units
NHTSA Ongoing

Possible Loss of Steering Control

March 17, 2020 Volkswagen Group of America, Inc. 229 units
NHTSA Ongoing

Possible Tread/Bead Detachment

March 17, 2020 YOKOHAMA TIRE CORPORATION 3,154 units
FDA Drug Class II Terminated

succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04

March 16, 2020 Pharmedium Services, LLC 2475 units units
FDA Drug Class II Terminated

Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. b

March 16, 2020 Glaxosmithkline Consumer Healthcare Holdings 471,024 blisters units
FDA Drug Class II Terminated

nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019

March 16, 2020 Pharmedium Services, LLC 80 units units
NHTSA Ongoing

Seat Belt May Not Secure Occupant/FMVSS 210

March 16, 2020 Eldorado National- Kansas 667 units
FDA Drug Class II Terminated

Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952

March 16, 2020 The Medicine Shoppe Pharmacy 4 bottles units
FDA Drug Class II Terminated

fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33

March 16, 2020 Pharmedium Services, LLC 75 units units
FDA Drug Class II Terminated

Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)

March 16, 2020 Glaxosmithkline Consumer Healthcare Holdings 151,056 bottles units
FDA Drug Class II Terminated

rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05

March 16, 2020 Pharmedium Services, LLC 2250 units units
FDA Drug Class I Terminated

Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories I

March 16, 2020 Dr. Reddy's Laboratories, Inc. 10943 cartons units
FDA Food Class I Terminated

Kudzu Root (Pueraria montana var. lobata), This product was packaged in a clear plastic bag or poly-woven bags sold in bulk form net weight ranges from 4 ounces to 20 pounds. The label is read in p

March 16, 2020 Mountain Rose Inc. dba Mountain Rose Herbs Lot 24247 = 31.75 lbs.; Lot 24247 X = 267.25 lbs. units
FDA Drug Class II Terminated

rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10

March 16, 2020 Pharmedium Services, LLC 4625 units units
FDA Drug Class II Terminated

fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cl

March 16, 2020 Pharmedium Services, LLC 290 units units
NHTSA Ongoing

Brake Lights Flash During Braking/FMVSS 108

March 16, 2020 BMW OF NORTH AMERICA, LLC 4,026 units
FDA Drug Class II Terminated

fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28

March 16, 2020 Pharmedium Services, LLC 1350 units units
FDA Drug Class II Terminated

ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02

March 16, 2020 Pharmedium Services, LLC 1500 units units
FDA Drug Class II Terminated

Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (or

March 16, 2020 Glaxosmithkline Consumer Healthcare Holdings 566 blister packs units
FDA Drug Class II Terminated

ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09

March 16, 2020 Pharmedium Services, LLC 900 units units
FDA Drug Class I Terminated

Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501

March 16, 2020 Y-O Management LLC, dba Natural Remedy Store 19156 packets estimated distributed units
FDA Drug Class II Terminated

fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50

March 16, 2020 Pharmedium Services, LLC 210 units units
FDA Drug Class II Terminated

Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB

March 16, 2020 Glaxosmithkline Consumer Healthcare Holdings 4,104 bottles units
FDA Drug Class II Terminated

ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12

March 16, 2020 Pharmedium Services, LLC 1075 units units
FDA Drug Class II Terminated

HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44

March 16, 2020 Pharmedium Services, LLC 1840 units units
FDA Drug Class II Terminated

Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95

March 16, 2020 Glaxosmithkline Consumer Healthcare Holdings 446,628 bottles units
FDA Drug Class II Terminated

ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09

March 16, 2020 Pharmedium Services, LLC 375 units units