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 III
Terminated
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutic
October 4, 2023
Sun Pharmaceutical Industries Inc.
144 bottles units
NHTSA
Ongoing
Fuel Sensor May Leak Fuel
October 3, 2023
HARLEY-DAVIDSON MOTOR COMPANY
1,139 units
FDA Drug
Class III
Terminated
Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 E
October 3, 2023
Imprimis NJOF, LLC
364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag) units
NHTSA
Ongoing
Stowed Griddle Can Cause Fire
October 3, 2023
REV Recreation Group
14 units
NHTSA
Ongoing
Tires Contain Metal Fragments
October 3, 2023
CONTINENTAL TIRE THE AMERICAS, LLC.
3,472 units
NHTSA
Ongoing
Incorrect Fuse May Cause Fire
October 2, 2023
FOREST RIVER, INC.
50 units
FDA Drug
Class II
Terminated
Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 141
October 2, 2023
Pine Pharmaceuticals, LLC
2484 syringes units
NHTSA
Ongoing
ABS Unit May Cause Engine Compartment Fire
October 2, 2023
Mando America Corporation
3,372,743 units
FDA Drug
Class II
Terminated
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
2176 syringes units
FDA Drug
Class II
Terminated
Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
130 units
FDA Drug
Class II
Terminated
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
860 syringes units
FDA Drug
Class II
Terminated
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
4972 syringes units
FDA Drug
Class I
Terminated
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5
October 2, 2023
Pfizer Inc.
24,900 vials units
NHTSA
Ongoing
Undersized Wire in Power Control System
October 2, 2023
Precision Circuits Inc.
176 units
FDA Drug
Class II
Terminated
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
662 dropper units
NHTSA
Ongoing
Incorrect Information on Federal Placard
October 2, 2023
FOREST RIVER, INC.
370 units
NHTSA
Ongoing
Cables May Contact Brackets Causing Short Circuit
October 2, 2023
WINNEBAGO INDUSTRIES, INC.
4,968 units
NHTSA
Ongoing
Incorrectly Adjusted Headlights/FMVSS 108
October 2, 2023
MERCEDES-BENZ USA, LLC.
32 units
FDA Drug
Class II
Terminated
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
881 pre-filled syringes units
FDA Drug
Class II
Terminated
Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
201 kits units
FDA Drug
Class II
Terminated
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
2862 Syringes units
FDA Drug
Class II
Terminated
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
9673 vials units
FDA Drug
Class I
Terminated
1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 040
October 2, 2023
Pfizer Inc.
21,390 vials units
NHTSA
Ongoing
Undersized Wire in Power Control System
October 2, 2023
Brinkley RV
143 units
FDA Food
Class II
Terminated
Maisie Jane's Smooth almond butter, 12 oz glass jar, 6 units per case, shelf stable
October 2, 2023
Maisie Jane's California Sunshine Products Inc.
4,834 jars units
FDA Drug
Class II
Terminated
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
1598 droppers units
FDA Drug
Class II
Terminated
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
1693 droppers units
FDA Drug
Class I
Terminated
2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 04
October 2, 2023
Pfizer Inc.
3,200 vials units
FDA Drug
Class II
Terminated
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
2181 droppers units
NHTSA
Ongoing
Delayed Trailer Brake Release/FMVSS 121
October 2, 2023
PACCAR, INCORPORATED
254 units
FDA Drug
Class II
Terminated
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
26 vials units
FDA Drug
Class II
Terminated
Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
136 syringes units
FDA Drug
Class II
Terminated
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
October 2, 2023
Pine Pharmaceuticals, LLC
128 bags units
NHTSA
Ongoing
Damaged Relays May Short Circuit
September 29, 2023
Firefly Integrations, LLC
113 units
FDA Drug
Class II
Terminated
ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA
September 29, 2023
Biomic Sciences, LLC dba ION Intelligence of Nature
N/A units
FDA Food
Class I
Terminated
FreshPoint Bix Produce Company, Cantaloupe. Item # 03143. 3 melons per bag.
September 29, 2023
Bix Produce Company LLC
61 - 3 packs units
NHTSA
Ongoing
Missing Secondary Emergency Exit
September 29, 2023
FOREST RIVER, INC.
6 units
FDA Drug
Class II
Terminated
Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
September 29, 2023
Biomic Sciences, LLC dba ION Intelligence of Nature
N/A units
CPSC
Ongoing
Future Motion Recalls Onewheel Self-Balancing Electric Skateboards Due to Crash Hazard; Four Deaths Reported
September 29, 2023
Future Motion Inc., of Santa Cruz, California
300000 units
NHTSA
Ongoing
Steering Column Shaft Pinch Bolt Not Secured
September 29, 2023
AUTOCAR, LLC
1,131 units
FDA Drug
Class I
Terminated
ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
September 29, 2023
Biomic Sciences, LLC dba ION Intelligence of Nature
N/A units
NHTSA
Ongoing
Loss of Drive Power from Inverter Software Error
September 29, 2023
NISSAN NORTH AMERICA, INC.
9,813 units
NHTSA
Ongoing
Spare Tire Winch System May Fail
September 29, 2023
Diamond C Trailer MFG.
2,523 units
FDA Food
Class III
Terminated
ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.
September 28, 2023
ActiPharma, Inc.
607 bottles of 100 tablets each units
FDA Drug
Class II
Ongoing
Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular
September 28, 2023
Eugia US LLC
1,626 vials units
CPSC
Ongoing
Trek Recalls Allant+ 7 Bicycles Due to Crash Hazard
September 28, 2023
About 7,000 units
CPSC
Ongoing
Secura Recalls Air Fryers Due to Fire and Burn Hazards (Recall Alert)
September 28, 2023
About 6,400 (In addition, about 680 were sold in Canada) units
CPSC
Ongoing
Rust-Oleum Recalls Fluorescent Pink Spray Paint Due to Injury Hazard
September 28, 2023
Rust-Oleum Corp., of Vernon Hills, Illinois
About 84,000 units
CPSC
Ongoing
Procter & Gamble Recalls Zevo Fly, Gnat and Fruit Fly Insect Spray Due to Injury and Laceration Hazards
September 28, 2023
The Procter & Gamble Company, of Cincinnati, Ohio
About 8,600 units
CPSC
Ongoing
Polaris Recalls Ranger Recreational Off-Highway Vehicles and Pro XD Utility Vehicles, Gravely ATLAS Utility Vehicles, and Bobcat Utility Vehicles Due to Injury Hazard (Recall Alert)
September 28, 2023
Polaris Industries Inc., of Medina, Minnesota
About 280 (In addition, 2 were sold in Canada) units