Product Recalls in 2023

4,662 recalls issued this year

324

CPSC

2,220

FDA Food

1,122

FDA Drug

996

NHTSA

NHTSA Ongoing

Catalytic Converter and Exhaust Fasteners May Fail

April 27, 2023 BMW OF NORTH AMERICA, LLC 5 units
NHTSA Ongoing

Unsecured Transmission May Cause Rollaway

April 27, 2023 Chrysler (FCA US LLC) 165,503 units
FDA Food Class II Ongoing

reFORM

April 27, 2023 TruVision Health LLC 2,535 packs units
FDA Food Class II Ongoing

TruBoost 7 Day Experience Kit

April 27, 2023 TruVision Health LLC 14,510 packs units
FDA Food Class II Ongoing

truCONTROL 60 Count

April 27, 2023 TruVision Health LLC 73,450 packs units
NHTSA Ongoing

Blank LCD Display/FMVSS 101 & 138

April 27, 2023 Kia America, Inc. 108,936 units
FDA Food Class II Ongoing

TruControl 7 Day Trifold

April 27, 2023 TruVision Health LLC Unknown units
FDA Food Class II Ongoing

TruWeight and Energy Gen 2+ 60 Count

April 27, 2023 TruVision Health LLC 4,182 packs units
NHTSA Ongoing

HV Battery Cell Monitoring Circuit Not Secured

April 27, 2023 BMW OF NORTH AMERICA, LLC 31 units
FDA Food Class II Ongoing

Truvy 30-Day Experience Kit

April 27, 2023 TruVision Health LLC 9,693 packs units
FDA Food Class II Ongoing

truControl W/Dynamine 60 ct

April 27, 2023 TruVision Health LLC 31,353 packs units
FDA Food Class II Ongoing

TruBoost Drink - Ruby Rev

April 27, 2023 TruVision Health LLC 4,650 packs units
FDA Food Class II Ongoing

Truvy Boost 30-Day Experience Kit

April 27, 2023 TruVision Health LLC 22,125 packs units
NHTSA Ongoing

Rear Driveshafts May Fracture

April 27, 2023 HYUNDAI MOTOR AMERICA 1,790 units
FDA Drug Class III Terminated

Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28

April 27, 2023 Teva Pharmaceuticals USA, Inc. 1908 units
NHTSA Ongoing

Incorrectly Installed Spare Tire Carrier

April 27, 2023 TIFFIN MOTORHOMES, INC. 203 units
FDA Food Class II Ongoing

TruBoost Drink - Citrine Spark

April 27, 2023 TruVision Health LLC 1,789 packs units
CPSC Ongoing

Vornado Recalls Steamfast and Brookstone Travel Steam Irons Due to Fire, Burn and Shock Hazards

April 27, 2023 About 317,000 (In addition, about 5,000 in Canada) units
CPSC Ongoing

Pool Drain Covers Recalled Due to Violation of the Virginia Graeme Baker Pool and Spa Safety Act; Imported by Pickloud-US (Recall Alert)

April 27, 2023 About 100 units
CPSC Ongoing

Pool Drain Covers Recalled Due to Violation of the Virginia Graeme Baker Pool and Spa Safety Act and Entrapment Hazard; Imported by Vijayli-US (Recall Alert)

April 27, 2023 About 116 units
FDA Drug Class III Terminated

Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28

April 27, 2023 Teva Pharmaceuticals USA, Inc. 1272 units
CPSC Ongoing

Pool Drain Covers Recalled Due to the Violation of the Virginia Graeme Baker Pool and Spa Safety Act and Entrapment Hazard; Imported by Liusin (Recall Alert)

April 27, 2023 About 40 units
CPSC Ongoing

EGL Motor Recalls ACE-branded Youth All-Terrain Vehicles (ATVs) Due to Violation of Federal ATV Safety Standard; Risk of Serious Injury or Death

April 27, 2023 About 4,000 units
FDA Drug Class II Ongoing

Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Food Class II Completed

Culinaria Branded Roasted & Salted Colossal Cashew & Macadamia Mix. Net Wt 9oz (255g) UPC 0 41318-22428 3. Distributed by Schnuck Markets, Inc., St. Louis, MO 63146-6928.

April 26, 2023 A. L. Schutzman Company, Inc. 828 cans units
FDA Food Class II Terminated

Trader Joes Instant Cold Brew Coffee, 3.5 oz.(99g), 24 jars per case.

April 26, 2023 Regal Trading, Inc. 14,112 cases units
FDA Drug Class II Ongoing

Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
NHTSA Ongoing

Missing Belt Guard Reflector/FMVSS 108

April 26, 2023 INDIAN MOTORCYCLE COMPANY 4 units
NHTSA Ongoing

Brake Light Switch Malfunction/FMVSS 108 & 102

April 26, 2023 SUBARU OF AMERICA, INC. 4,030 units
FDA Food Class II Ongoing

TURKEY AND HAVARTI Sandwich NET WT. 8.55OZ (242g) CONTAINS MILK, SOY, WHEAT MAY CONTAIN EGG Distributed By Rennaissance Food Group, LLC 4322 Moreland Ave Conley, GA UPC 8 26766 15584 2

April 26, 2023 GARDEN HIGHWAY ATLANTA 1,147 sandwiches units
FDA Drug Class II Ongoing

Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

April 26, 2023 Akorn, Inc. N/A units
FDA Drug Class II Ongoing

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating C

April 26, 2023 Akorn, Inc. N/A units