Product Recalls in 2023

4,662 recalls issued this year

324

CPSC

2,220

FDA Food

1,122

FDA Drug

996

NHTSA

FDA Drug Class II Terminated

Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highwa

July 10, 2023 Sun Pharmaceutical Industries Inc. 8,880 30-count bottles units
NHTSA Ongoing

Ball Joint Failure May Cause Loss of Steering

July 10, 2023 Ironman 4x4 USA II LLC 6,345 units
FDA Food Class III Terminated

Natural Systems, Naturasys MULTI VITAMIN HIGH POTENCY AND FORMULATION, Dietary Supplement 60 Tablets

July 10, 2023 Emceta International Inc. 554 bottles/60 tablets each units
FDA Drug Class II Ongoing

Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL

July 10, 2023 Tenn South Distillery LLC dba Big Machine Distillery 540 gallons units
FDA Drug Class II Terminated

SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10

July 10, 2023 New England Life Care, Inc. dba Advanced Compounding Solutions 493 syringes units
FDA Drug Class II Terminated

ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05

July 10, 2023 New England Life Care, Inc. dba Advanced Compounding Solutions 500 Syringes units
NHTSA Ongoing

Front Brake Caliper May Detach

July 10, 2023 YAMAHA MOTOR CORPORATION, USA 211 units
FDA Drug Class II Terminated

Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;

July 10, 2023 New England Life Care, Inc. dba Advanced Compounding Solutions 209 Bags units
FDA Food Class I Terminated

365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kits 12 oz plastic bags 9 bags per case UPC: 9948246932 Item#: 9770522

July 10, 2023 Braga Fresh Foods 673 cases units
NHTSA Ongoing

Knee Air Bag Manufactured Incorrectly

July 10, 2023 BMW OF NORTH AMERICA, LLC 1,981 units
FDA Drug Class II Terminated

PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;

July 10, 2023 New England Life Care, Inc. dba Advanced Compounding Solutions 82 Bags units
FDA Food Class III Terminated

Lipton Diet Green Tea Citrus, 24 pack of 16.9floz bottles. UPC # 0-12000-01722-3

July 8, 2023 Pepsico Inc 300, 24 packs (retail unit) units
FDA Drug Class II Terminated

Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 703

July 7, 2023 SterRx, LLC 132,299 bags units
NHTSA Ongoing

Spare Tire Carrier Assembly Chain May Break

July 7, 2023 Toyota Motor Engineering & Manufacturing 1,398 units
FDA Drug Class II Terminated

Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC

July 7, 2023 SterRx, LLC 92,148 bags units
FDA Food Class II Terminated

Ziyad Brand Jameed Soup Starter sold in a 35.2 fluid ounce tetra pak container with UPC code 0 74265 00597 1. 12 units per wholesale case

July 7, 2023 ZB Importing LLC 60,109 cases units
FDA Drug Class II Terminated

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, ND

July 7, 2023 SterRx, LLC 137,304 bags units
FDA Drug Class II Terminated

Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 7

July 7, 2023 SterRx, LLC 2,088 bags units
FDA Drug Class II Terminated

Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 703

July 7, 2023 SterRx, LLC 125,598 bags units
NHTSA Ongoing

Seat Belt Mounting Bracket May Fail/FMVSS 210

July 7, 2023 NEWMAR CORPORATION 372 units
NHTSA Ongoing

Loss of Drive Power from Improperly Welded Axle

July 7, 2023 Daimler Trucks North America LLC 82 units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Champagne Bulk Truffles, perishable, sold individual pieces out of retail display cases. The display placard declares milk in the ingredients statement, but the Contains s

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Himalayan Pink Salt Bulk Caramels, perishable, sold individual pieces out of retail display cases. The display placard declares cream and butter in the ingredients stateme

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Dark Raspberry Bulk Truffles, perishable, sold individual pieces out of retail display cases. The display placard declares cream and butter in the ingredients statement, b

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Alderwood Smoked Bulk Caramels, perishable, sold individual pieces out of retail display cases. The display placard declares milk in the ingredients statement, but the Con

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Amaretto Bulk Truffle, perishable, sold individual pieces out of retail display cases. The display placard declares milk chocolate and almond extract in the ingredients st

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Espresso Bulk Caramels, perishable, sold individual pieces out of retail display cases. The display placard declares milk in the ingredients statement, but the Contains st

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Praline Bulk Truffles, perishable, sold individual pieces out of retail display cases. The display placard declares milk, pecans, and almonds in the ingredients statement,

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Dark Ginger Bulk Truffles, perishable, sold individual pieces out of retail display cases. The display placard declares milk in the ingredients statement, but the Contains

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class I Terminated

Betty Lou's Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds, shelf-stable, 12-month shelf life, 1.5 oz (42g) package and 12/1.5 oz. packages per display box. Packages are sold i

July 6, 2023 Betty Lou's, Inc. 1174 bars units
FDA Food Class II Terminated

SPRING VALLEY brand POTATO BLINTZES; NET WT. 13 OZ (369g); KEEP FROZEN; READY TO COOK; INGREDIENTS: WHEAT FLOUR (WHET FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE, RIBOFLAVEN, ENZYME, FOLIC ACID),

July 6, 2023 Milmar Food Corp 100 cases units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Light Ephemere Bulk Truffles, perishable, sold in individual pieces out of retail display cases. The display placard declares cream and butter in the ingredients statement

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Rheingold White Bulk Toffee, perishable, sold individual pieces out of retail display cases. The display placard declares milk, pecans and hazelnuts in the first Contains

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Sriracha Bulk Caramels, perishable, sold individual pieces out of retail display cases. The display placard declares cream and butter in the ingredients statement, but the

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Rheingold Milk Bulk Toffee, perishable, sold individual pieces out of retail display cases. The display placard declares milk, pecans, and almonds in the ingredients state

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand L'Orange Dark Bulk Truffles, perishable, sold individual pieces out of retail display cases. The display placard declares milk in the ingredients statement, but the Contai

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
CPSC Ongoing

woom Bikes USA Recalls woom ORIGINAL Kids' Bicycles Due to Fall Hazard

July 6, 2023 woom Bikes USA, of Austin, Texas About 84,000 (In addition, 533 were sold in Canada) units
CPSC Ongoing

Husqvarna Recalls Residential 300 Series Snow Blowers Due to Injury Hazard

July 6, 2023 Husqvarna Professional Products Inc., of Charlotte, North Carolina About 2,700 (In addition, about 4,400 were sold in Canada) units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Espresso Bulk Truffles, perishable, sold individual pieces out of retail display cases. The display placard declares milk in the ingredients statement, but the Contains st

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
CPSC Ongoing

VRURC Portable Chargers Recalled Due to Fire Hazard; Sold Exclusively on Amazon.com by VRURC; Caught Fire on Commercial Flight

July 6, 2023 About 190,000 units
CPSC Ongoing

Yamaha Golf Car Company Recalls Model Year 2023 Golf Cars, Personal Transportation Vehicles And Umax Due to Crash and Injury Hazards and Risk of Death (Recall Alert)

July 6, 2023 Yamaha Motor Powered Products Co. Ltd., of Japan About 11,000 (In addition, about 2,200 were sold in Canada) units
NHTSA Ongoing

Improperly Tightened U-Bolt

July 6, 2023 Lippert 13,997 units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Dark Ephemere Bulk Truffles, perishable, sold individual pieces out of retail display cases. The display placard declares milk, cream, and butter in the ingredients statem

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Food Class III Terminated

Dilettante Mocha Cafe brand Rheingold Dark Bulk Toffees, perishable, sold individual pieces out of retail display cases. The display placard declares butter, pecans, and almonds in the ingredients st

July 6, 2023 Dilettante Chocolates Inc firm did not provide units
FDA Drug Class III Terminated

Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by

July 5, 2023 Sun Pharmaceutical Industries Inc. 20,884 cartons units
FDA Drug Class II Terminated

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00

July 5, 2023 B. Braun Medical Inc 79,880 bags units
FDA Drug Class II Terminated

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28

July 5, 2023 Teva Pharmaceuticals USA, Inc. 180 bottles units
NHTSA Ongoing

Improperly Tightened Windshield Wiper Arms

July 5, 2023 MACK TRUCKS, INC 204 units
NHTSA Ongoing

Rearview Camera Image May Not Display/FMVSS 111

July 5, 2023 POLARIS INDUSTRIES, INC. 22,218 units
FDA Food Class II Terminated

Semolina Fettuccine, net wt. 14oz. Product is packaged in a clear clamshell plastic container. Label declares: Fresh & Hand Crafted Bellingham Pasta Co. Ingredients Semolina Flour, Water, Egg, dusted

July 3, 2023 Bellingham Pasta Co 175 packages units