Product Recalls in 2019

4,851 recalls issued this year

241

CPSC

1,807

FDA Food

1,788

FDA Drug

1,015

NHTSA

FDA Drug Class II Terminated

MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-901-05.

February 8, 2019 Avella of Deer Valley, Inc. Store 38 250 52 mL bags units
NHTSA Ongoing

Transmission Software May Cause Abrupt Downshift

February 8, 2019 MAZDA NORTH AMERICAN OPERATIONS 14,370 units
FDA Drug Class II Terminated

Indian Herb Paste (a dietary supplement) Ingredients: Galangal, Indian Paint, Yellow Dock & Licorice in an alloy of Life-Line tm and Zinc Chloride in 6 dram vials, McDaniel Life-Line LLC, Dimmitt, TX

February 8, 2019 McDaniel Life-Line LLC 150 vials units
NHTSA Ongoing

Break-Away Switch May Disconnect From Battery

February 8, 2019 FOREST RIVER, INC. 2,454 units
NHTSA Ongoing

Incorrect Odometer Display/FMVSS 101

February 8, 2019 Isuzu Technical Center of America, Inc. 264 units
NHTSA Ongoing

Brake Pedal May Separate From Pedal Assembly

February 8, 2019 Chrysler (FCA US LLC) 193,813 units
NHTSA Ongoing

Taillights May Loosen and Detach

February 8, 2019 BMW OF NORTH AMERICA, LLC 5,920 units
NHTSA Ongoing

Unintentional Front Brake Application

February 8, 2019 INDIAN MOTORCYCLE COMPANY 60 units
NHTSA Ongoing

Loss of Electric Power Steering Assist

February 8, 2019 SUBARU OF AMERICA, INC. 10,417 units
FDA Drug Class II Terminated

MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-902-05.

February 8, 2019 Avella of Deer Valley, Inc. Store 38 4,950 54 mL bags units
FDA Drug Class II Terminated

MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Specialty Pharmacy 24416 N 19 th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-907-05.

February 8, 2019 Avella of Deer Valley, Inc. Store 38 8,500 54 mL bags units
NHTSA Ongoing

Engine Oil Leak May Cause Stall or Fire

February 8, 2019 HYUNDAI MOTOR AMERICA 120,000 units
NHTSA Ongoing

Loss of Steering without Warning

February 8, 2019 Daimler Vans USA, LLC 4,358 units
FDA Drug Class II Terminated

Life-Line tm Catalytic Activated Energy Water, 1 gallon container, McDaniel Life-Line LLC 1775 US Hwy 385 806-647-1741 Dimmitt, TX 79027

February 8, 2019 McDaniel Life-Line LLC Unknown units
NHTSA Ongoing

Brake Lights May Randomly Illuminate

February 8, 2019 Life Line Emergency Vehicles 200 units
NHTSA Ongoing

Transmission Software May Cause Abrupt Downshift

February 8, 2019 Aisin World Corp. of America 24,265 units
FDA Food Class II Terminated

Watermelon, WTRMLNWTR Cold Pressured, 12fl oz, Watermelon Flavor, Refrigerated

February 8, 2019 World Waters, LLC dba WTRMLN WTR 277,230 units units
NHTSA Ongoing

Transmission Software May Cause Abrupt Downshift

February 8, 2019 Chrysler (FCA US LLC) 8,950 units
FDA Food Class I Terminated

DG Baby Gripe Water herbal supplement with organic ginger and fennel extracts, 4 FL OZ (120 mL) Liquid Dietary Supplement UPC: 8 54954 00246 3

February 7, 2019 Kingston Pharma LLC 138,752 bottles units
FDA Food Class II Terminated

Frozen IQF Strawberries packed in a flexible polybag. Each bag is 2 lbs (906.5g), 6 bags per case. UPC is UPC: 0 22518 87710 3. The label of 2 lb. bag is read in parts: "***STRAWBERRIES***KEEP F

February 7, 2019 Willamette Valley Pie Company, LLC. 1,448 cases (6/2 lb. bags per case) units
FDA Drug Class III Terminated

Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37

February 7, 2019 ACP Nimble Buyer, Inc. 58,176 units units
CPSC Ongoing

Delta Electronics Recalls Solar Inverters Due to Fire and Impact Hazards

February 7, 2019 About 2,600 units
FDA Food Class II Terminated

Frozen IQF Red Raspberries packed in a flexible polybag. Each bag is 2 lbs (906.5g), 6 bags per case. UPC is 0 22518 87750 9. The label of 2 lb. bag is read in parts: "***Red Raspberries ***WILLAM

February 7, 2019 Willamette Valley Pie Company, LLC. 1,221 cases (6/2 lb. bags per case) units
FDA Food Class II Terminated

Craft Granola Goldenola Turmeric & Ginger, packaged in 3 oz. and 11 oz. poly bag, UPC: 860157002028 and 8601570020135

February 7, 2019 Birdseed Food Co LLC 440 packages total units
FDA Drug Class III Terminated

Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally

February 6, 2019 Dr. Reddy's Laboratories, Inc. 40,592, 90 and 1,000 count bottles units
CPSC Ongoing

Dell Recalls Hybrid Power Adapters Sold with Power Banks Due to Shock Hazard

February 6, 2019 Lite-On Technology Corporation of Taipei, Taiwan About 8,900 (in addition, about 475 were sold in Canada) units
FDA Drug Class II Terminated

Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bottles (NDC 47593-488-31) Ecolab, 370 Wabasha Street N, St. Paul

February 6, 2019 Ecolab Inc a) 118 units, b) 3,783 units units
FDA Drug Class II Terminated

Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC 47593-487-33), and c) 540 mL (18 fl oz) bottles (NDC47593-487-3

February 6, 2019 Ecolab Inc a) 22 units b) 314 units c) 3511 units units
FDA Drug Class III Terminated

Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77

February 6, 2019 Advanced Pharma Inc. 672 bags units
FDA Drug Class II Terminated

Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49

February 6, 2019 Ecolab Inc 105 units units
FDA Drug Class III Terminated

Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77

February 6, 2019 Advanced Pharma Inc. 12 bags units
FDA Drug Class II Terminated

Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-489-33

February 6, 2019 Ecolab Inc 30 units units
FDA Drug Class II Terminated

Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (87

February 6, 2019 Advanced Pharma Inc. 100 syringes units
FDA Drug Class III Terminated

Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 7705

February 6, 2019 Advanced Pharma Inc. 1460 bottles units
FDA Drug Class II Terminated

Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85

February 6, 2019 Ecolab Inc 67 units units
CPSC Ongoing

Fisher-Price Recalls Children's Power Wheels Barbie Campers Due to Injury Hazard

February 5, 2019 About 44,000 units
CPSC Ongoing

DeWALT Recalls Drills Due to Shock Hazard

February 5, 2019 DeWALT Industrial Tool Company, of Towson, Md. About 122,000 (in addition, about 8,000 were sold in Canada) units
FDA Drug Class II Terminated

Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.

February 4, 2019 Akorn, Inc. 78120 dropper bottles units
FDA Food Class II Terminated

Jacques Big Daddy Dark Chocolate Bar. The product comes in un-coded 2.2 lbs. (1kg) clear plastic package overwrapped with reddish brown paper label.

February 4, 2019 Jacques Torres Manufacturing , llc. 293 bars units
FDA Drug Class II Terminated

0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09

February 4, 2019 ICU Medical Inc 475320 bags units
FDA Food Class I Terminated

Stacy's Simply Naked Pita Chips 7 1/3 ounce bags

February 4, 2019 Frito-Lay, Inc 288 bags units
FDA Food Class I Terminated

Whole Foods Hipster Chipster Cookies; 9 oz. container with 6 cookies; UPC 0247449 006990 Sold at Whole Foods, Yulupa Ave., Santa Rosa, CA

February 1, 2019 Whole Foods Market 8 containers sold units
FDA Drug Class I Terminated

Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30

February 1, 2019 Mylan Institutional Inc 11,964 cartons of 30 vials units
FDA Drug Class III Terminated

Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 77

February 1, 2019 Lupin Pharmaceuticals Inc. 43,860 3ml bottles units
FDA Food Class III Terminated

Hikari Enjuku Koji Miso Mutenka; 26.6 oz. plastic tub with lid. UPC 4 905663 003007

February 1, 2019 Hikari Miso International, Inc. 224 cases ( 8 tubs per case) units
FDA Drug Class II Terminated

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India,

February 1, 2019 Mylan Pharmaceuticals Inc. 10,390 bottles units
NHTSA Ongoing

Brake Application Timing/FMVSS 121

January 31, 2019 Spartan Motors USA 138 units
NHTSA Ongoing

Insufficient Tire Load Range

January 31, 2019 HEARTLAND RECREATIONAL VEHICLES, LLC 14 units
NHTSA Ongoing

Crankshaft Pulley Bolt May Fracture

January 31, 2019 JAGUAR LAND ROVER NORTH AMERICA, LLC 443 units
NHTSA Ongoing

Improperly Welded Fuel Rails May Leak Fuel

January 31, 2019 Volkswagen Group of America, Inc. 74,881 units