Product Recalls in 2022

4,158 recalls issued this year

292

CPSC

1,425

FDA Food

1,391

FDA Drug

1,050

NHTSA

FDA Drug Class II Ongoing

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only,

October 13, 2022 Akorn, Inc. 314,543 10ml,3ml, 5ml bottles units
FDA Drug Class II Ongoing

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated,

October 13, 2022 Akorn, Inc. 163,996 bottles units
FDA Food Class II Terminated

Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case

October 13, 2022 Abbott Laboratories 14,588,544 bottles TOTAL units
FDA Drug Class II Ongoing

Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35

October 13, 2022 Akorn, Inc. 524,506 tubes units
NHTSA Ongoing

Front Seat Belt Pretensioners May Fail

October 13, 2022 Chrysler (FCA US LLC) 2,802 units
FDA Food Class II Terminated

Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton

October 13, 2022 Abbott Laboratories 14,588,544 bottles TOTAL units
FDA Drug Class III Terminated

Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA.

October 13, 2022 Aadi Bioscience 2,333 vials units
FDA Drug Class II Ongoing

Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19

October 13, 2022 Akorn, Inc. 2,563 bottles units
NHTSA Ongoing

Delayed Rearview Camera Image/FMVSS 111

October 13, 2022 Volkswagen Group of America, Inc. 5 units
FDA Drug Class II Ongoing

Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest,

October 13, 2022 Akorn, Inc. 2,369,258 tubes units
FDA Drug Class II Ongoing

Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25

October 13, 2022 Akorn, Inc. 1,584 bottles units
FDA Drug Class II Ongoing

ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35

October 13, 2022 Akorn, Inc. 1,109,600 tubes units
FDA Food Class II Terminated

Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton

October 13, 2022 Abbott Laboratories 14,588,544 bottles TOTAL units
NHTSA Ongoing

Unsecured Fuse inside High Voltage Battery

October 13, 2022 Chrysler (FCA US LLC) 13,722 units
FDA Drug Class II Ongoing

Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05

October 13, 2022 Akorn, Inc. 91,692 bottles units
FDA Drug Class II Ongoing

Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10

October 13, 2022 Akorn, Inc. 2,095,068 bottles units
NHTSA Ongoing

Fuel Pump Failure

October 13, 2022 Chrysler (FCA US LLC) 390 units
FDA Drug Class II Ongoing

AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35

October 13, 2022 Akorn, Inc. 36,025 tubes units
CPSC Ongoing

U.P. Fashion Recalls Children's Rings Due to Violation of Federal Lead Content Ban

October 13, 2022 About 1,800 units
CPSC Ongoing

Children's Sleepwear Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by Jammers Apparel Group; Sold Exclusively at JCPenney

October 13, 2022 About 450 units
FDA Drug Class II Ongoing

Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05

October 13, 2022 Akorn, Inc. 1,752 bottles units
FDA Food Class II Terminated

Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit

October 13, 2022 Abbott Laboratories 14,588,544 bottles TOTAL units
FDA Food Class II Terminated

Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case

October 13, 2022 Abbott Laboratories 14,588,544 bottles TOTAL units
FDA Drug Class II Ongoing

PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12

October 13, 2022 Akorn, Inc. 51,601 bottles units
CPSC Ongoing

U-Line Recalls Outdoor Freezers Due to Fire Hazard

October 13, 2022 U-Line Corporation, of Milwaukee, Wisconsin About 90 units
FDA Drug Class II Ongoing

Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05

October 13, 2022 Akorn, Inc. 65,006 bottles units
FDA Drug Class II Ongoing

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05

October 13, 2022 Akorn, Inc. 121,176 bottles units
CPSC Ongoing

Newair Recalls Magic Chef Air Fryers Due to Fire and Burn Hazards

October 13, 2022 About 11,750 units
FDA Drug Class II Ongoing

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15

October 13, 2022 Akorn, Inc. 23,026 bottles units
CPSC Ongoing

Early Learning Centre Little Senses Lights & Sounds Shape Sorter Toys Due to Choking Hazard; Manufactured by Addo Play; Sold Exclusively at Amazon.com

October 13, 2022 Addo Play Ltd., of United Kingdom About 9,300 units
FDA Food Class II Terminated

Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packaged as: 48 count case

October 13, 2022 Abbott Laboratories 14,588,544 bottles TOTAL units
FDA Drug Class II Ongoing

Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12

October 13, 2022 Akorn, Inc. 967,075 bottles units
FDA Drug Class II Ongoing

Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10

October 13, 2022 Akorn, Inc. 3108 bottles units
FDA Drug Class II Ongoing

Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35

October 13, 2022 Akorn, Inc. 2,082 tubes units
FDA Food Class I Terminated

Hammond's Salted Caramel Cookies, NET WT. 5 OZ (142g), UPC 6 91355 89889 5, Manufactured for: Hammond's Candies, 5735 Washington St, Denver, CO 80216. Cookies are packaged in sealed, opaque, white, pl

October 13, 2022 Hammond's Candies Since 1920 II, LLC 216-496 units (27-62 cases) units
CPSC Ongoing

Cressi-Sub USA Recalls Scuba Diver Buoyancy Compensator Devices Due to Drowning Hazard

October 13, 2022 About 1,350 units
FDA Food Class II Terminated

Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case

October 13, 2022 Abbott Laboratories 15,865,104 TOTAL bottles units
FDA Drug Class II Ongoing

Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35

October 13, 2022 Akorn, Inc. 1,164,171 tubes units
CPSC Ongoing

Children's Sleepwear Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by Ekouaer; Sold Exclusively at Amazon.com

October 13, 2022 About 9,200 units
FDA Drug Class II Ongoing

Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10

October 13, 2022 Akorn, Inc. 6,273 bottles units
FDA Drug Class II Ongoing

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05

October 13, 2022 Akorn, Inc. 31,073 bottles units
CPSC Ongoing

Bombardier Recreational Products (BRP) Recalls Snowmobiles Due to Fire Hazard (Recall Alert)

October 13, 2022 About 6,200 (In addition, about 3,900 were sold in Canada) units
FDA Food Class II Terminated

Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case

October 13, 2022 Abbott Laboratories 14,588,544 bottles TOTAL units
NHTSA Ongoing

Loss of Drive Power

October 12, 2022 Kia America, Inc. 69,038 units
NHTSA Ongoing

Entrance Door Handrail Incorrect Diameter

October 12, 2022 BLUE BIRD BODY COMPANY 20 units
FDA Food Class II Terminated

"***Nestle***STUFFED***CHOCOLATE CHIP COOKIE DOUGH***4 JUMBO COOKIES***NET WT 8 OZ***"

October 12, 2022 Nestle-USA, Inc. (Corporate Office) 38,972 cases units
NHTSA Ongoing

Hopper Hydraulic Lift System Malfunction

October 12, 2022 Alamo Group Inc. 3 units
NHTSA Ongoing

Insufficient Roof Panel Joint Strength/FMVSS 221

October 12, 2022 Daimler Trucks North America LLC 17,613 units
FDA Drug Class III Terminated

NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Str

October 11, 2022 LNK International, Inc. 66,384 boxes of twenty tablets each units
NHTSA Ongoing

Window may be Missing Emergency Exit

October 11, 2022 KZRV, L.P. 42 units