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 I Ongoing

CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20)

November 13, 2023 Kilitch Healthcare India Limited 137,784 bottles units
NHTSA Ongoing

Incorrect Shift Selector May Result in Rollaway

November 13, 2023 HINO MOTORS SALES U.S.A., INC. 985 units
FDA Drug Class I Ongoing

Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1

November 13, 2023 Kilitch Healthcare India Limited 12,960 bottles units
FDA Drug Class I Ongoing

Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA

November 13, 2023 Kilitch Healthcare India Limited 9,216 bottles units
FDA Drug Class I Ongoing

CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 7616

November 13, 2023 Kilitch Healthcare India Limited 45,408 bottles units
FDA Drug Class I Ongoing

Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite

November 13, 2023 Kilitch Healthcare India Limited 7,296 bottles units
FDA Drug Class I Ongoing

Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3

November 13, 2023 Kilitch Healthcare India Limited 7,776 bottles units
FDA Drug Class I Ongoing

Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5

November 13, 2023 Kilitch Healthcare India Limited 7,200 bottles units
FDA Drug Class I Ongoing

CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI

November 13, 2023 Kilitch Healthcare India Limited 110,832 bottles units
FDA Drug Class II Ongoing

KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-096-02,

November 13, 2023 KINDER FARMS LLC 376,370 bottles units
FDA Drug Class I Ongoing

LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5

November 13, 2023 Kilitch Healthcare India Limited 6,024 bottles units
NHTSA Ongoing

Incorrect Load Carrying Capacity Label/FMVSS 110

November 13, 2023 SOUTHEAST TOYOTA DISTRIBUTORS, LLC 534 units
FDA Drug Class I Ongoing

Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30

November 13, 2023 Kilitch Healthcare India Limited 137,544 bottles units
NHTSA Ongoing

Improperly Cured Tire Tread May Separate

November 13, 2023 Sentury Tire Thailand 8,900 units
FDA Drug Class II Ongoing

KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04, U

November 13, 2023 KINDER FARMS LLC 591,684 bottles units
FDA Drug Class I Ongoing

Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94

November 13, 2023 Kilitch Healthcare India Limited 1,492,344 bottles units
FDA Drug Class I Ongoing

Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30

November 13, 2023 Kilitch Healthcare India Limited 2,820 bottles units
FDA Drug Class I Ongoing

CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 7

November 13, 2023 Kilitch Healthcare India Limited 386,256 bottles units
FDA Drug Class I Ongoing

Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000

November 13, 2023 Kilitch Healthcare India Limited 210,192 bottles units
FDA Drug Class I Ongoing

CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 7616

November 13, 2023 Kilitch Healthcare India Limited 150,720 bottles units
FDA Drug Class I Ongoing

CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI

November 13, 2023 Kilitch Healthcare India Limited 253,080 bottles units
FDA Drug Class I Ongoing

EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC

November 13, 2023 Kilitch Healthcare India Limited 33,984 bottles units
FDA Drug Class I Ongoing

Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (T

November 13, 2023 Kilitch Healthcare India Limited 401,568 bottles units
FDA Drug Class I Ongoing

Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94

November 13, 2023 Kilitch Healthcare India Limited 56,520 bottles units
FDA Drug Class I Ongoing

Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0089-1

November 13, 2023 Kilitch Healthcare India Limited 23,208 bottles units
FDA Food Class I Terminated

Fruit Medley Cup 16/6 oz 3300-3 Cantaloupe Cube (2/5 lb) 3338-3 Fruit Mix Kit (4/5 lb) (Tray) 2963-3 3 Melon 16/6 oz cups 3330-3 Fruit Mix (2/5 lb) 3301-3 Cantaloupe Cube (5 lb) 3304-3 Cantaloupe Cube

November 10, 2023 Vinyard Fruit & Vegetable Co., LLC 599 cases and 459 each units
FDA Drug Class III Terminated

Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30

November 10, 2023 Teva Pharmaceuticals USA, Inc.
FDA Food Class I Terminated

GreenGate Fresh Standard Cello Spinach; 4 - 2.5lb plastic bags per box; SKU 465; Perishable hence require refrigeration at all times of its shelflife

November 10, 2023 GreenGate Fresh LLLP 11 cases units
FDA Drug Class III Ongoing

Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug,

November 10, 2023 Fagron Compounding Services 756 bottles units
FDA Drug Class II Terminated

PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., To

November 10, 2023 Golden State Medical Supply Inc. 5626 bottles units
FDA Drug Class II Terminated

PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., To

November 10, 2023 Golden State Medical Supply Inc. 1941 bottles units
FDA Drug Class II Terminated

PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packag

November 10, 2023 Golden State Medical Supply Inc. 2502 bottles units
CPSC Ongoing

Textron Specialized Vehicles Recalls Arctic Cat and Tracker Side by Side Recreational Off Highway Vehicles Due to Crash Hazard (Recall Alert)

November 9, 2023 Textron Specialized Vehicles, of Augusta, Georgia About 6,800 (In addition, about 700 were sold in Canada) units
CPSC Ongoing

Polaris Recalls RANGER Off-Road Vehicles Due to Fire and Crash Hazards (Recall Alert)

November 9, 2023 Polaris Industries Inc., of Medina, Minnesota About 1,025 (In addition, about 40 were sold in Canada) units
CPSC Ongoing

Magnolia Market Recalls 3-Wick Glass Candles Due to Fire and Laceration Hazards (Recall Alert)

November 9, 2023 About 4,350 units
CPSC Ongoing

DR Power Equipment Recalls Tow-Behind Field & Brush Mowers Due to Fire and Burn Hazards

November 9, 2023 DR Power Equipment, of South Burlington, Vermont, a subsidiary of Generac Power Systems Inc., of Waukesha, Wisconsin (through January 2018) About 2,930 (In addition, 102 were sold in Canada) units
CPSC Ongoing

Children's Nightgowns Recalled Due to Burn Hazard and Violation of Federal Flammability Standards; Sold by iMOONZZZ Exclusively on Amazon.com

November 9, 2023 About 13,300 units
FDA Drug Class II Terminated

fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceutical

November 9, 2023 SCA Pharmaceuticals, LLC 412 cassettes units
FDA Drug Class II Terminated

PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816

November 9, 2023 SCA Pharmaceuticals, LLC 2,427 syringes units
FDA Food Class I Terminated

Freshly Made Signature Fruit 32oz bowl UPC 092538002298

November 9, 2023 Market Cuts LLC 8 individual units units
FDA Drug Class II Terminated

fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 B

November 9, 2023 SCA Pharmaceuticals, LLC 548 bags units
FDA Drug Class II Terminated

HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 700040300

November 9, 2023 SCA Pharmaceuticals, LLC 1,425 syringes units
FDA Drug Class III Terminated

LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 1

November 9, 2023 Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop 190 syringes units
FDA Drug Class II Terminated

SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 7000

November 9, 2023 SCA Pharmaceuticals, LLC 5,079 syringe units
FDA Food Class II Terminated

Bonta Natural Artisan Gelato Stracciatella is frozen dessert, packaged in blue cardboard pint cups (UPC 58745 00309) and in green cardboard half-gallon tubs (UPC 58745 00306). The 1 Pint label is rea

November 9, 2023 Bonta - Natural Artisan Gelato LLC 1 pint container = 20. Half-Gallon container = 4 units
CPSC Ongoing

Amer Sports Winter & Outdoor Recalls Ski Touring Bindings Due to Fall and Injury Hazards

November 9, 2023 About 4,250 (In addition, about 1,446 were sold in Canada) units
FDA Drug Class II Terminated

fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, ND

November 9, 2023 SCA Pharmaceuticals, LLC 1,259 syringes units
FDA Drug Class II Terminated

HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar

November 9, 2023 SCA Pharmaceuticals, LLC 256 cassettes units
FDA Drug Class II Terminated

HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Ba

November 9, 2023 SCA Pharmaceuticals, LLC 1,023 syringes units
FDA Drug Class II Terminated

PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-081

November 9, 2023 SCA Pharmaceuticals, LLC 10,017 syringes, expanded 2579 syringes units