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 Ongoing

buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceut

December 29, 2023 Rising Pharma Holding, Inc. 47,976 bottles units
FDA Drug Class II Terminated

Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380

December 29, 2023 Strides Pharma INC 396 50-count bottles units
FDA Food Class I Terminated

Soy Bean Sprouts in a package labeled in part: Sam Sung Soy Bean Sprouts, Net Wt. 1LB have a Sell By date of December 21, 2023.

December 29, 2023 Samsung Bean Sprout 500 bags units
FDA Food Class III Terminated

365 Whole Foods Vegan Ultimate Veggie, Thin Cust Pizza. Item # 999209512 Topped with Vegan Mozzarella-Style Cheese, Green and Red Bell Peppers, Mushrooms, Black Olives and Red Onions. Net Wt 13.7 o

December 29, 2023 Richelieu Foods, Inc. 183 cases units
FDA Food Class I Terminated

201000 TUNA, HAWAII #1 USA W LB 201002 TUNA HAWAII #1 USA W LB 201200 TUNA FRESH, WILD Y/F,B/E #2 GRADE 201300 TUNA BLUEFIN SPAIN SPA F LB 201301 TUNA BLUEFIN SPAIN (SE) SPAIN F LB 201304 TUNA BL

December 29, 2023 Ocean Group Inc. 166 pieces units
FDA Food Class I Terminated

202225 SALMON BAKKA FROST FILLET 6/7KG FR FRO F LB 202002 SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB 202012 SALMON BAKKAFROST FAROE ISLANDS 6/7KG FR FRO F LB 202022 SALMON BAKKAFROST FAROE I

December 29, 2023 Ocean Group Inc. 18,042 fillet pieces units
FDA Drug Class II Ongoing

Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 678

December 29, 2023 Ascend Laboratories LLC 3,288 bottles units
FDA Drug Class II Ongoing

DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.

December 28, 2023 Fresenius Medical Care Holdings, Inc. 69,590 bags units
FDA Drug Class II Ongoing

Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancas

December 28, 2023 Seaway Pharma Inc. 4,176 bottles units
FDA Drug Class II Ongoing

Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI

December 28, 2023 Seaway Pharma Inc. 8,160 bottles units
CPSC Ongoing

BlendJet Recalls 4.8 Million BlendJet 2 Portable Blenders Due to Fire and Laceration Hazards

December 28, 2023 BlendJet Inc., of Benicia, California About 4.8 million (in addition, about 117,000 were sold in Canada) units
CPSC Ongoing

FNA Group Recalls Simpson Pressure Washers Due to Burn Hazard; Sold Exclusively at Lowe's

December 28, 2023 FNA Group Inc., of Pleasant Prairie, Wisconsin About 2,930 units
CPSC Ongoing

High-Powered Magnetic Balls Recalled Due to Ingestion Hazard; Sold Exclusively on Walmart.com through Joybuy

December 28, 2023 About 4,240 units
FDA Food Class II Terminated

Wellsley Farms Assorted Mini Quiches NET WT 36 OZ (2LB 4 OZ) 1.02kb Keep Frozen UPC: 8867002630. Packaged in plastic trays in a cardboard box. 2 sealed trays in a box, 10 boxes per case

December 28, 2023 The Fillo Factory Inc. approximately 3412 retail units units
FDA Drug Class I Ongoing

VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.

December 28, 2023 Denver Solutions, LLC DBA Leiters Health 10,152 IV bags units
FDA Drug Class I Ongoing

FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.

December 28, 2023 Denver Solutions, LLC DBA Leiters Health 8,976 IV bags units
FDA Drug Class I Ongoing

VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.

December 28, 2023 Denver Solutions, LLC DBA Leiters Health 7,548 IV bags units
FDA Drug Class I Ongoing

FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.

December 28, 2023 Denver Solutions, LLC DBA Leiters Health 13,920 IV bags units
FDA Drug Class I Ongoing

PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.

December 28, 2023 Denver Solutions, LLC DBA Leiters Health 29,016 IV bags units
FDA Drug Class II Ongoing

Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, M

December 28, 2023 Seaway Pharma Inc. 7,992 bottles units
FDA Drug Class I Ongoing

PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.

December 28, 2023 Denver Solutions, LLC DBA Leiters Health 12,564 IV bags units
FDA Drug Class II Ongoing

Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 6386

December 28, 2023 Seaway Pharma Inc. 7,992 bottles units
NHTSA Ongoing

Vehicle Rollaway from Incorrect Gear Shifter

December 27, 2023 Daimler Trucks North America LLC 2,547 units
NHTSA Ongoing

120-Volt Passenger Outlets May Detach

December 27, 2023 Daimler Coaches North America 66 units
NHTSA Ongoing

Engine Compartment Fire from Short Circuit

December 27, 2023 HYUNDAI MOTOR AMERICA 10,984 units
NHTSA Ongoing

Rear Axle Hub Bolt May Break

December 27, 2023 FORD MOTOR COMPANY 112,965 units
NHTSA Ongoing

Overloaded Electrical System May Cause Fire

December 27, 2023 Rosenbauer America 543 units
NHTSA Ongoing

Software Error May Cause Unintended Acceleration

December 27, 2023 NEW FLYER OF AMERICA, INC. 246 units
NHTSA Ongoing

Software Error May Cause Unintended Acceleration

December 27, 2023 NEW FLYER OF AMERICA, INC. 211 units
NHTSA Ongoing

Steering Gear Assembled Incorrectly

December 27, 2023 MACK TRUCKS, INC 284 units
NHTSA Ongoing

Steering Gear Assembled Incorrectly

December 27, 2023 VOLVO TRUCKS NORTH AMERICA 1 units
NHTSA Ongoing

Drag Link May Become Deformed or Break

December 27, 2023 CRANE CARRIER COMPANY 1,327 units
FDA Drug Class II Terminated

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewate

December 26, 2023 Amneal Pharmaceuticals of New York, LLC. 21,452/100 count bottles units
FDA Drug Class III Ongoing

Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose

December 26, 2023 Amerisource Health Services LLC 6,344 cartons units
FDA Drug Class I Ongoing

Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 0705

December 26, 2023 Haleon US Holdings LLC a) 31,632 bottles; b) 336,528 bottles units
NHTSA Ongoing

Fuel Pump Shutdown May Cause Loss of Drive Power

December 26, 2023 MERCEDES-BENZ USA, LLC. 79,676 units
NHTSA Ongoing

Awning May Extend Unintentionally

December 26, 2023 CAREFREE OF COLORADO 8,115 units
NHTSA Ongoing

Missing Frame Member Reinforcement Fasteners

December 26, 2023 Daimler Vans USA, LLC 3,739 units
NHTSA Ongoing

Partition Wall May Detach

December 26, 2023 Daimler Vans USA, LLC 387 units
NHTSA Ongoing

Fuel Pump Shutdown May Cause Loss of Drive Power

December 26, 2023 Daimler Vans USA, LLC 13,726 units
NHTSA Ongoing

Improper Seal May Allow Oil and Fuel to Leak

December 26, 2023 MERCEDES-BENZ USA, LLC. 7 units
NHTSA Ongoing

Bumper Mounted Spare Tire Carrier May Detach

December 26, 2023 Winnebago Towable 1,313 units
NHTSA Ongoing

Crossmember Connection May Loosen

December 26, 2023 Daimler Vans USA, LLC 9 units
NHTSA Ongoing

Engine Compartment Fire

December 26, 2023 Kia America, Inc. 79,812 units
NHTSA Ongoing

Loss of Drive Power from Unsecured Inverter Cable

December 26, 2023 Daimler Trucks North America LLC 26 units
NHTSA Ongoing

Inversion Valve Failure/FMVSS 121

December 26, 2023 HALDEX COMMERCIAL VEHICLE SYSTEMS 4,717 units
NHTSA Ongoing

Loose Bolts May Cause A Loss of Steering Control

December 26, 2023 NISSAN NORTH AMERICA, INC. 5 units
NHTSA Ongoing

Overloaded Electrical System May Cause Fire

December 26, 2023 REV Ambulance Group Orlando, INC. 210 units
NHTSA Ongoing

Auto-Hold or Park May Not Activate as Intended

December 26, 2023 Rivian Automotive, LLC 7,873 units
NHTSA Ongoing

Dump Truck Hoist May Fail

December 26, 2023 Alamo Group Inc. 195 units