Product Recalls in 2019

4,851 recalls issued this year

241

CPSC

1,807

FDA Food

1,788

FDA Drug

1,015

NHTSA

FDA Food Class I Terminated

Ottogi Beijing Spicy Seafood Noodle 5PK 1lb 5.16oz x 8pk Item #32142408 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Food Class I Terminated

Ottogi Spicy Seafood flavor Udon Odongtong 5PK 1lb 5.16oz x 8pk Item #32142410 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Food Class I Terminated

Ottogi Jin Ramen Mild Bowl, 5PK 3.88oz x 12ea, 1 lb 5.16oz x 8pk, 4.23oz x 12ea, cup 2.29 oz x 6 cup Item #21309025, 32142401, 21501201, 32143021 Manufactured by: Ottogi Ramyon Co. Ltd. Distribute

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Food Class I Terminated

Ottogi Ramen Sari (Extra Noodle) 3.88oz x 48ea Item #21101009 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Drug Class II Terminated

Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ

January 15, 2019 LUPIN SOMERSET 24,180 bottles units
FDA Food Class I Terminated

Ottogi Yeul Ramen (Bowl) 4.06oz x 12ea Item #21305007 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Food Class I Terminated

Ottogi Snack Ramen 5PK, Cup 1lb 3.05oz x 8pk, 2.18oz x 6ea Item #21501281, 21502161 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Food Class I Terminated

Ottogi Ramen Bokki (Cup) 4.23oz x 12ea Item #21309009 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Food Class I Terminated

Ottogi Ppushu Ppushu Spicy Flavor 3.17oz x 40ea Item #21503008 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Food Class I Terminated

Ottogi BuckwheatChilli Noodle PK 1lb 6.93oz x 8pk Item #32143061 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Drug Class II Terminated

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716,

January 15, 2019 Tris Pharma Inc. 35,328 bottles units
FDA Food Class I Terminated

Ottogi Jin Jjambbong Spicy Seafood Noodle 4.58 oz x 4 ea Item #32142443 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Food Class I Terminated

Ottogi Jin Ramen Spicy, Bowl, 5PK 4.23oz x 20ea, 3.88oz x 12ea, 1lb 5.16oz x 8pk Item #21501202, 21502155, 32142402 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 165

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Food Class I Terminated

Ottogi Ppushu Ppushu Bulgogi Flavor 3.17oz x 40ea Item #21503005 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Drug Class II Terminated

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS

January 15, 2019 Tris Pharma Inc. 46,080 bottles units
FDA Food Class I Terminated

Ottogi Ppushu Ppushu Grilled Chicken Flavor 3.17oz x 40ea Item #21503006 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249

January 15, 2019 Ottogi America Inc 1,594,338 units units
FDA Food Class II Terminated

Snak Club Praline Pecans Made With Cane Sugar NET Wt. 2.25 oz (64 g) Produced By: Century Snack Commerce, CA 90040 centurysnacks.com

January 14, 2019 Century Snacks LLC 25 packages units
FDA Food Class II Terminated

CTFO Sleep Support Oral Spray with pure CBD Hemp Oil isolate Dietary Supplement, 1oz/30ml.

January 11, 2019 Nutrafuels, Inc. 676 units units
FDA Drug Class III Terminated

Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi

January 11, 2019 Oxalis Labs 53,358 bottles units
FDA Food Class I Terminated

El Guapo Chile Habanero Habanero Chili Pepper 0.5oz

January 11, 2019 McCormick & Company, Inc. - Flavor Manufacturing Center 47,044 pouches units
FDA Food Class I Terminated

El Guapo Pasilla-Ancho Chile Pods 2oz, 7.5oz, 11oz

January 11, 2019 McCormick & Company, Inc. - Flavor Manufacturing Center 2 oz, 22,848 pouches ; 7.5oz, 13,896 pouches ; 11oz, 2,064 pouches units
FDA Food Class II Terminated

CTFO Pain Relief Oral Spray with pure CBD Hemp Oil isolate Dietary Supplement, 1oz/30ml.

January 11, 2019 Nutrafuels, Inc. 840 units units
FDA Food Class II Terminated

CTFO Weight Loss Oral Spray with pure CBD Hemp Oil isolate Dietary Supplement, 1oz/30ml.

January 11, 2019 Nutrafuels, Inc. 1,011 units units
FDA Drug Class II Terminated

Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.

January 10, 2019 MAJOR PHARMACEUTICALS 3,102 Cartons (310,200 tablets) units
FDA Drug Class II Terminated

Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704

January 10, 2019 McGuff Compounding Pharmacy Services, Inc. 146 30 ml vials were dispensed units
FDA Drug Class II Terminated

Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-

January 9, 2019 Lupin Pharmaceuticals Inc. 14,400 bottles units
FDA Food Class I Terminated

Chips & Chocolate, A layered dessert with chocolate mousse layer on the bottom, with a white whipped topping layer on top topped with chocolate chips, 5 lb. tray, UPC Code 010742015408

January 8, 2019 Winter Gardens Quality Foods, Inc. 138/5 lb. trays (690 lbs.) units
FDA Drug Class I Terminated

5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644

January 8, 2019 Happy Together, Inc. N/A units
FDA Food Class I Terminated

Paul Revere's Pizza, Pizza Crust Mix, Manufactured by Pizza Blends Bellevue, WA packaged in 26.70 lb bags.

January 7, 2019 Pizza Blends, LLC 269 cases units
FDA Food Class I Terminated

FourStar Pizza & Subs, Pizza Dough Premix, Manufactured by Pizza Blends, Inc. San Antonio, TX. packaged in 26 lb bags.

January 7, 2019 Pizza Blends, LLC 1,680 cases units
FDA Food Class I Terminated

The Great American by Pizza Blends, Pizza Dough Mix No Yeast, Manufactured by Pizza Blends, Inc. San Antonio, TX. packaged in 24 lb bags.

January 7, 2019 Pizza Blends, LLC 1,004 cases units
FDA Food Class I Terminated

The Great American by Pizza Blends, Pizza Dough Mix With Yeast, Manufactured by Pizza Blends, Inc. San Antonio, TX. packaged in 24 lb bags.

January 7, 2019 Pizza Blends, LLC 1,280 cases units
FDA Food Class I Terminated

Village Pizza & Seafood, Custom Pizza Flour, Manufactured Exclusively for Village Pizza & Seafood League City, TX, packaged in 21.7 lb bags.

January 7, 2019 Pizza Blends, LLC 198 cases units
FDA Food Class I Terminated

Chicago's Pizza Base Mix, Manufactured Exclusively for Chicago's Pizza, Greenfield, IN packaged in 30 lb bags.

January 7, 2019 Pizza Blends, LLC 4,784 cases units
FDA Food Class I Terminated

Very Good Foods, Complete Round Dough Mix, Manufactured Exclusively for Askar Brands, Bloomfield Hills, MI, packaged in 27 lb bags.

January 7, 2019 Pizza Blends, LLC 1,966 cases units
FDA Food Class I Terminated

CEC Entertainment, Inc., Proprietary Pizza Dough Premix, Manufactured Exclusively for CEC Entertainment, Irving, TX packaged in 24 lb bags.

January 7, 2019 Pizza Blends, LLC 52,718 cases units
FDA Food Class I Terminated

CEC Entertainment, Inc., No Yeast Proprietary Pizza Dough Premix, Manufactured Exclusively for CEC Entertainment, Irving, TX packaged in 24 lb bags.

January 7, 2019 Pizza Blends, LLC 1,916 cases units
FDA Food Class I Terminated

Peter Piper, Two-N-One Dough, Manufactured Exclusively for Peter Piper Pizza, Phoenix, AZ. packaged in 26 lb bags.

January 7, 2019 Pizza Blends, LLC 826 cases units
FDA Drug Class II Terminated

Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- N

January 7, 2019 Lupin Pharmaceuticals Inc. 7,215 bottles units
FDA Food Class I Terminated

HyVee brand Strawberry-flavored cheese cakes packaged in the following ways: 1) Strawberry Cheesecake, Net Wt. 8 OZ, HyVee West Des Moines, IA UPC 02 80150 XXXXX packaged in clear plastic container

January 4, 2019 Hy-Vee Stores Inc 2,608 32 oz and other similar sizes; 4,367 8 oz and other similar sizes units
FDA Food Class II Terminated

WESTCREEK H&R SELF RISE AP FLR 25LB and 50LB

January 4, 2019 Ardent Mills, LLC
FDA Food Class I Terminated

HyVee brand Strawberry-flavored Bettercreme cheese cakes packaged in the following ways: 1) Strawberry Bettercreme Cheesecake, Net Wt. 8 OZ, HyVee West Des Moines, IA UPC 02 82317 XXXXX packaged in

January 4, 2019 Hy-Vee Stores Inc 2,608 32 oz and other similar sizes; 4,367 8 oz and other similar sizes units
FDA Food Class II Terminated

HILLTOP HEARTH SELF RISE FLR 25LB and 50LB

January 4, 2019 Ardent Mills, LLC
FDA Food Class I Terminated

HyVee brand Pumpkin-fluff -flavored cheese cakes packaged in the following ways: 1) Pumpkin-fluff Cheesecake, Net Wt. 7 OZ, HyVee West Des Moines, IA UPC 02 80148 XXXXX packaged in clear plastic co

January 4, 2019 Hy-Vee Stores Inc 2,608 32 oz and other similar sizes; 4,367 8 oz and other similar sizes units
FDA Food Class I Terminated

HyVee brand Oreo-flavored Bettercreme cheese cakes packaged in the following ways: 1) Oreo Bettercreme Cheesecake, Net Wt. 8 OZ, HyVee West Des Moines, IA UPC 02 82331 XXXXX packaged in clear plast

January 4, 2019 Hy-Vee Stores Inc 2,608 32 oz and other similar sizes; 4,367 8 oz and other similar sizes units
FDA Food Class I Terminated

HyVee brand Smores-flavored Bettercreme cheese cakes packaged in the following ways: 1) Smores Bettercreme Cheesecake, Net Wt. 7 OZ, HyVee West Des Moines, IA UPC 02 82333 XXXXX packaged in clear p

January 4, 2019 Hy-Vee Stores Inc 2,608 32 oz and other similar sizes; 4,367 8 oz and other similar sizes units
FDA Food Class I Terminated

Chocolate instant pudding and pie filling mix packaged in the following ways: 1) Classic Sysco Chocolate Instant Pudding & Pie Filling Mix, Net Wt. 24 OZ, Distributed by Sysco Corporation, Houston,

January 4, 2019 Diamond Crystal Brands Inc 6,480 cases units
FDA Food Class I Terminated

HyVee brand Oreo-flavored cheese cakes packaged in the following ways: 1) Oreo Cheesecake, Net Wt. 8 OZ, HyVee West Des Moines, IA UPC 02 80146 XXXXX packaged in clear plastic containers; 2) Ore

January 4, 2019 Hy-Vee Stores Inc 2,608 32 oz and other similar sizes; 4,367 8 oz and other similar sizes units
FDA Food Class II Terminated

MEMBERS MARK SELF RISE FLR 25LB

January 4, 2019 Ardent Mills, LLC
FDA Food Class I Terminated

HyVee brand Lemon-flavored Bettercreme cheese cakes packaged in the following ways: 1) Lemon Bettercreme Cheesecake, Net Wt. 7 OZ, HyVee West Des Moines, IA UPC 02 82319 XXXXX packaged in clear pla

January 4, 2019 Hy-Vee Stores Inc 2,608 32 oz and other similar sizes; 4,367 8 oz and other similar sizes units