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

Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Hea

February 7, 2023 Accord Healthcare, Inc. 36,773 bottles units
FDA Drug Class II Terminated

Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceu

February 7, 2023 Accord Healthcare, Inc. 322 vials units
FDA Drug Class II Terminated

Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle ND

February 7, 2023 Accord Healthcare, Inc. 665,469 bottles units
FDA Drug Class II Terminated

BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382

February 7, 2023 Accord Healthcare, Inc. 10992 bottles units
FDA Drug Class II Terminated

Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 21

February 7, 2023 Accord Healthcare, Inc. 120 bottles units
NHTSA Ongoing

Cooktop Gas Valves May Fracture Causing Gas Leak

February 7, 2023 Pleasant Valley Teardrop Trailers LLC 640 units
FDA Drug Class II Terminated

Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 2; Manufactured for: Acco

February 7, 2023 Accord Healthcare, Inc. 63,247 bottles units
FDA Drug Class II Terminated

Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17 UPC 3 16729 41517 0; Manufactured for: Accord Healthcare, Inc.

February 7, 2023 Accord Healthcare, Inc. 31,116 bottles units
FDA Drug Class II Terminated

Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottle NDC 16729-285-17, UPC 3 16729 28517 9; Manufactured for: Acco

February 7, 2023 Accord Healthcare, Inc. 56,862 bottles units
FDA Drug Class II Terminated

Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-count bottle NDC 16729-211-17 UPC 3 16729 21117 8; Manufactured for: Accord Healthc

February 7, 2023 Accord Healthcare, Inc. 44,068 bottles units
FDA Drug Class II Terminated

Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC

February 7, 2023 Accord Healthcare, Inc. 2641 bottles units
NHTSA Ongoing

Power Steering Hose May Detach

February 7, 2023 Nova Bus (US) Inc. 17 units
NHTSA Ongoing

Seat Belt Assembly Malfunction

February 7, 2023 TOKAI RIKA Co LTD 106 units
FDA Drug Class II Terminated

BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-38

February 7, 2023 Accord Healthcare, Inc. 23,784 bottles units
FDA Drug Class II Terminated

Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles NDC 16729-286-17, UPC 3 16729 28617 6; Manufactured for: Accord

February 7, 2023 Accord Healthcare, Inc. 43,302 bottles units
FDA Drug Class II Terminated

Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-count bottle NDC 16729-156-17, UPC 3 16729 15617 2; Manufactured for: Accord Healt

February 7, 2023 Accord Healthcare, Inc. 256,648 bottles units
FDA Drug Class II Terminated

rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, N

February 7, 2023 Accord Healthcare, Inc. 14,928 bottles units
FDA Drug Class II Terminated

Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez,

February 7, 2023 Accord Healthcare, Inc. 9,888 vials units
FDA Drug Class II Terminated

Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Heal

February 7, 2023 Accord Healthcare, Inc. 205,631 bottles units
FDA Drug Class II Terminated

rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA.

February 7, 2023 Accord Healthcare, Inc. 25,344 bottles units
NHTSA Ongoing

Battery Disconnect Switch May Fail

February 7, 2023 NEWELL COACH CORP. 13 units
FDA Drug Class II Terminated

Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle NDC 16729-004-17, UPC 3 16729 00417 6; Manufactured for: Accord H

February 7, 2023 Accord Healthcare, Inc. 291,378 bottles units
FDA Drug Class II Terminated

Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213

February 7, 2023 Accord Healthcare, Inc. 113,571 bottles units
FDA Drug Class II Terminated

Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Heal

February 7, 2023 Accord Healthcare, Inc. 613,553 bottles units
FDA Drug Class II Terminated

BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382

February 7, 2023 Accord Healthcare, Inc. 3,784 bottles units
FDA Drug Class II Terminated

Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16 UPC 3 16729 00216 5; Manufactured for: Accord Healthcare, Inc.

February 7, 2023 Accord Healthcare, Inc. 992,622 bottles units
FDA Drug Class II Terminated

Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmac

February 7, 2023 Accord Healthcare, Inc. 5,273 vials units
FDA Drug Class II Terminated

Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-count NDC 16729-414-17 UPC 3 16729 41417 3; Manufactured for: Accord Healthcare, I

February 7, 2023 Accord Healthcare, Inc. 69,122 bottles units
FDA Drug Class II Terminated

BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382

February 7, 2023 Accord Healthcare, Inc. 25,812 bottles units
FDA Drug Class II Terminated

Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-count bottle NDC 16729-287-15, UPC 3 16729 28715 9; c) 1,000-count bottle NDC 167

February 7, 2023 Accord Healthcare, Inc. 102,360 bottles units
FDA Drug Class II Terminated

Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; Manufactured for: Accord Healthcar

February 7, 2023 Accord Healthcare, Inc. 72,376 bottles units
FDA Drug Class II Terminated

rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, ND

February 7, 2023 Accord Healthcare, Inc. 5,112 bottles units
FDA Drug Class II Terminated

Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16729-045-17 UPC 3 16729 04517 9, Manufactured for: Accord Health

February 7, 2023 Accord Healthcare, Inc. 241,585 bottles units
FDA Drug Class II Terminated

Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; Manufactured for: Accord Healt

February 7, 2023 Accord Healthcare, Inc. 176,323 bottles units
NHTSA Ongoing

Rearview Mirror May Detach

February 6, 2023 BOMBARDIER RECREATIONAL PRODUCTS INC. 2,077 units
FDA Food Class I Terminated

JSJ DMC Leaf Cake 3.35 oz (95g) 28 units per case produced date: 2022/11/08

February 6, 2023 Titans Global Inc. 12,432 units total units
FDA Food Class II Terminated

Arroyabe Bonito Flakes White Meat Tuna Flakes in Oil From the Basque region of Spain. Product is packaged in metal can, Net wt: 32oz (900g), Drained Weight: 21oz (590g). Ingredients: White Tuna, Sunf

February 6, 2023 Power Selles Imports dba Culinary Collective 28 cases (12 cans per case) units
FDA Food Class I Terminated

JSJ ZSR Cake 3.35 oz (95g) 28 units per case produced date: 2022/11/08

February 6, 2023 Titans Global Inc. 12,432 units total units
FDA Drug Class II Terminated

Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.

February 6, 2023 Alvogen, Inc 21,276 bottles units
NHTSA Ongoing

Over-pressurized Fluid Dispenser Lid May Detach

February 6, 2023 Harbor Freight Tools 34,570 units
NHTSA Ongoing

Awning Fabric May Detach Causing Awning to Drop

February 6, 2023 Nexus RVs, LLC 103 units
FDA Food Class I Terminated

JSJ Chocolate Cake 3.35 oz (95g) 28 units per case produced date: 2022/11/08

February 6, 2023 Titans Global Inc. 12,432 units total units
FDA Food Class II Terminated

Danncy Vainilla Pure Mexican Vanilla Extract Clear Gluten Free Produced by Juan Miguel Anzaldua Gutierrez NET 33.8 FL OZ (1.0L) UPC 7503000781137 packaged in clear plastic bottles and Danncy Vainilla

February 5, 2023 Danncy Vainilla ~1,542 boxes units
FDA Food Class I Terminated

Orchard Bistro, Egg Salad Wheat, Net . Wt. 5.5 Oz. Single Serving, Keep refrigerated

February 3, 2023 FRESH IDEATION FOOD GROUP, LLC dba Fresh Creative Cuisine 16 units
FDA Food Class I Terminated

Fresh Creative Cuisine White Label, Egg Salad Wheat Wedge, Single Serve, Keep refrigerated

February 3, 2023 FRESH IDEATION FOOD GROUP, LLC dba Fresh Creative Cuisine 11 units
FDA Food Class I Terminated

Fresh Creative Cuisine White Label, Petite Gouda & Fig Flat. Single Serving, Keep refrigerated

February 3, 2023 FRESH IDEATION FOOD GROUP, LLC dba Fresh Creative Cuisine 90 units
FDA Food Class I Terminated

Naval Academy 1845 Coffee, Ham, Swiss & Honey Mustard Bialy, Net . Wt. 6.5 Oz. Single Serving, Keep refrigerated

February 3, 2023 FRESH IDEATION FOOD GROUP, LLC dba Fresh Creative Cuisine 10 units
FDA Food Class I Terminated

Orchard Bistro, Fresh Mixed Berries, Net . Wt. 6 Oz. Single Serving, Keep refrigerated

February 3, 2023 FRESH IDEATION FOOD GROUP, LLC dba Fresh Creative Cuisine 10 units
FDA Food Class I Terminated

Quick & Fresh, Turkey Wheat, Net Wt. 4 Oz. Single Serving, Keep refrigerated

February 3, 2023 FRESH IDEATION FOOD GROUP, LLC dba Fresh Creative Cuisine 12 units
FDA Food Class I Terminated

Fresh Creative Cuisine, Blueberry Low Fat Yogurt, Fruit & Granola Parfait, Net . Wt. 9 Oz. Single Serving, Keep refrigerated

February 3, 2023 FRESH IDEATION FOOD GROUP, LLC dba Fresh Creative Cuisine 121 units units