Product Recalls in 2018

4,897 recalls issued this year

258

CPSC

1,977

FDA Food

1,681

FDA Drug

981

NHTSA

CPSC Ongoing

Signature Hardware Recalls Wall-Mounted Shower Seats Due to Fall and Laceration Hazards

December 4, 2018 About 7,200 (in addition, about 80 were sold in Canada) units
FDA Food Class II Terminated

1 lb QVC combo, 1 lb combo, 2 lb combo, 12 oz combo, 8 oz combo, holiday combo

December 4, 2018 Bauer's Candies, Inc. 24 lbs units
FDA Food Class II Terminated

Sea Salt Bauer's Candies Modjeskas NET WT 8 oz bag, bulk, 4 oz bag, 1 lb, 2 lb, 8 oz box

December 4, 2018 Bauer's Candies, Inc. 21 units
FDA Food Class I Terminated

HomeFresh FOODS Suya Barbecue Seasoning, UPC: 6 033000120298, Net Wt: 240g/0.53 lbs; Produced in Ghana by: ELSSY KESS COMPANY LTD GHANA

December 4, 2018 Ellgof Inc. 144 jars units
FDA Food Class II Terminated

Modjeskas Bauer's Candies NET WT 8 oz, 12 oz, 16 oz, 32 oz. boxes & 4 oz, 8 oz bags, 400 pc case, 216 pc case

December 4, 2018 Bauer's Candies, Inc. 97 lbs, 2 cases, 15 bulk units
FDA Food Class II Terminated

Diatomaceous Earth packaged in the following ways: 1) Perma-Guard, Fossil Shell Flour, Anti-caking agent, Food Chemical Codex Grade, Weight: 50 lb/22.6 kg, Bountiful, UT; 2) 100% Food Grade Diat

December 4, 2018 Earthworks Health N/A units
FDA Food Class II Terminated

bulk chocolate bourbon caramels

December 4, 2018 Bauer's Candies, Inc. 1 bulk case units
FDA Food Class II Terminated

8 oz assorted modjeska/chocolate modjeskas

December 4, 2018 Bauer's Candies, Inc. 1 case units
FDA Food Class II Terminated

Bauer's Candies Caramels NET WT 4 oz (bag) & bulk, QVC 4 pack caramels

December 4, 2018 Bauer's Candies, Inc. 3 bags and 3 bulk units
FDA Food Class II Terminated

QVC 40 ct vanilla & dark choc modjeskas

December 4, 2018 Bauer's Candies, Inc. 5 lbs units
FDA Food Class II Terminated

Bauer's Candies Chocolate Modjeskas NET WT 4 oz & 8 oz bags, 8 oz box, bulk, & 1 lb box

December 4, 2018 Bauer's Candies, Inc. 8 bags, 16 boxes, 1 bulk units
FDA Food Class II Terminated

Bourbon Sea Salt Bauer's Candies Caramels NET WT 4 oz & 8 oz (bag) & bulk

December 4, 2018 Bauer's Candies, Inc. 3 bags, 2 bulk units
FDA Food Class II Terminated

bulk chocolate caramels

December 4, 2018 Bauer's Candies, Inc. 1 bulk case units
FDA Food Class II Terminated

1 lb salted combo modjeskas

December 4, 2018 Bauer's Candies, Inc. 4 lbs units
FDA Food Class II Terminated

Bulk assorted

December 4, 2018 Bauer's Candies, Inc. 2 cases units
FDA Drug Class II Ongoing

Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceutic

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 32,284 HDPE bottles units
FDA Drug Class II Ongoing

Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceutic

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 22,813 HDPE bottles units
FDA Drug Class II Ongoing

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceut

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 50,595 HDPE bottles units
FDA Drug Class II Ongoing

Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 129,754 HDPE bottles units
FDA Drug Class II Ongoing

Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 119,761 HDPE bottles units
FDA Drug Class II Ongoing

Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1722-93.

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 76,516 HDPE bottles units
FDA Drug Class II Ongoing

Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 232,180 HDPE bottles units
FDA Drug Class II Terminated

Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01

December 4, 2018 Epic Pharma, LLC 2976 bottles units
FDA Drug Class II Ongoing

Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuti

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 32,696 HDPE bottles units
FDA Drug Class II Ongoing

Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 141,995 HDPE bottles units
FDA Drug Class II Ongoing

Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93.

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 109,314 HDPE bottles units
FDA Drug Class II Ongoing

Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceut

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 19,352 HDPE bottles units
FDA Drug Class II Ongoing

Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93.

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 160,300 HDPE bottles units
FDA Drug Class II Ongoing

Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93.

December 4, 2018 Mylan Laboratories Limited, (Nashik FDF) 84,066 HDPE bottles units
NHTSA Ongoing

Tailgate Spoiler May Detach

December 4, 2018 MERCEDES-BENZ USA, LLC. 16 units
NHTSA Ongoing

Trailer may Separate from Gooseball

December 4, 2018 Horizon Global 621 units
NHTSA Ongoing

Pillar Mounting Holes Incorrect Size/FMVSS 214 226

December 4, 2018 HONDA (AMERICAN HONDA MOTOR CO.) 404 units
NHTSA Ongoing

Steering Rack Locknut May Fail, Affecting Steering

December 4, 2018 MERCEDES-BENZ USA, LLC. 6,373 units
NHTSA Ongoing

Insufficient Grease on Bearings may cause Failure

December 4, 2018 JAYCO, INC. 149 units
FDA Food Class I Terminated

Hiland Chocolate Milk, 1/2 gallon (1.89 L). Hiland Dairy Springfield, MO 65803

December 3, 2018 Hiland Dairy Foods Company LLC 1,151 half-gallons units
NHTSA Ongoing

Missing or Insufficiently Tightened Fasteners

December 3, 2018 ALTEC INDUSTRIES INC. 49 units
NHTSA Ongoing

Brake Actuator Mounting Washer May Fracture

December 3, 2018 TSE Brakes 264 units
NHTSA Ongoing

School Bus Seats may Detach from Floor/FMVSS 210

December 3, 2018 BLUE BIRD BODY COMPANY 12 units
NHTSA Ongoing

Insufficient Grease on Bearings may cause Failure

December 3, 2018 KEYSTONE RV COMPANY 982 units
NHTSA Ongoing

Incorrect Thread may Allow Ski Bag to Detach

December 3, 2018 PORSCHE CARS NORTH AMERICA, INC. 142 units
NHTSA Ongoing

Incorrect Thread may Allow Ski Bag to Detach

December 3, 2018 PORSCHE CARS NORTH AMERICA, INC. 95 units
NHTSA Ongoing

Transmission Clutch Slip and Fluid Leak

December 3, 2018 FORD MOTOR COMPANY 2,828 units
FDA Food Class I Terminated

Salmon fillets packaged inside Styrofoam boxes fully surrounded and covered in ice, which were stored inside a temperature controlled cooler

November 30, 2018 K & T Oriental Imports Inc. 3,094 kgs (161 packs) units
FDA Drug Class III Terminated

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 658

November 30, 2018 Aurobindo Pharma USA Inc 4464 bottles units
FDA Drug Class III Terminated

NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml

November 30, 2018 VistaPharm, Inc. 4,065,550 5 ml cups units
NHTSA Ongoing

Incorrect Display of Passenger Air Bag Status

November 30, 2018 MERCEDES-BENZ USA, LLC. 104,663 units
NHTSA Ongoing

Loss of Electric Power Steering Assist

November 30, 2018 MERCEDES-BENZ USA, LLC. 7 units
NHTSA Ongoing

Observation Glass can Shatter from Road Debris

November 30, 2018 CHAMPION BUS, INC. 88 units
NHTSA Ongoing

Brake Line Corrosion may Affect Brake Performance

November 30, 2018 PORSCHE CARS NORTH AMERICA, INC. 112 units
NHTSA Ongoing

Water May Enter Windshield Wire Harness

November 30, 2018 Fujian Wanda Automobile Glass Industry C 8,202 units