Product Recalls in 2018
4,897 recalls issued this year
258
CPSC
1,977
FDA Food
1,681
FDA Drug
981
NHTSA
FDA Drug
Class II
Terminated
Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply
April 3, 2018
Kroger Specialty Pharmacy, Inc.
Unknown units
FDA Drug
Class II
Terminated
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
April 3, 2018
Kroger Specialty Pharmacy, Inc.
Unknown units
FDA Drug
Class II
Terminated
Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply
April 3, 2018
Kroger Specialty Pharmacy, Inc.
Unknown units
FDA Drug
Class II
Terminated
Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply
April 3, 2018
Kroger Specialty Pharmacy, Inc.
Unknown units
FDA Drug
Class II
Terminated
Ibrance 125 mg cap NDC 00069-0189-21 28 days supply
April 3, 2018
Kroger Specialty Pharmacy, Inc.
Unknown units
FDA Drug
Class II
Terminated
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
April 3, 2018
Kroger Specialty Pharmacy, Inc.
Unknown units
FDA Drug
Class II
Terminated
Temozolomide 20 mg NDC 43975-0253-05 28 days supply
April 3, 2018
Kroger Specialty Pharmacy, Inc.
Unknown units
FDA Drug
Class II
Terminated
Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply
April 3, 2018
Kroger Specialty Pharmacy, Inc.
Unknown units
FDA Drug
Class II
Terminated
MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply.
April 3, 2018
Kroger Specialty Pharmacy, Inc.
N/A units
FDA Drug
Class II
Terminated
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
April 3, 2018
Kroger Specialty Pharmacy, Inc.
Unknown units
NHTSA
Ongoing
Front Axle Spindle may Fracture
April 2, 2018
Spartan Motors USA
11 units
NHTSA
Ongoing
Air Bag Inflator Housing Material Failure
April 2, 2018
MERCEDES-BENZ USA, LLC.
57 units
CPSC
Ongoing
Polaris Recalls RZR XP 1000 Recreational Off-Highway Vehicles (ROVs) Due to Fire Hazard
April 2, 2018
Polaris Industries, Inc., of Minn.
About 107,000 units
NHTSA
Ongoing
Brake and Lighting Wiring Damage/FMVSS 135, 108
April 2, 2018
Futura Trailers Ltd
204 units
NHTSA
Ongoing
Seat Belt Buckle Casings may Fail
April 2, 2018
VAN HOOL, N.V.
1,528 units
NHTSA
Ongoing
Seatbacks may Not Lock
April 2, 2018
MERCEDES-BENZ USA, LLC.
3,088 units
FDA Drug
Class II
Terminated
WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 66670 03988 6.
April 2, 2018
Diamond Wipes International, Inc.
5,148,792 pouches units
NHTSA
Ongoing
Front Axle Spindle may Fracture
April 2, 2018
Timoney Technology
146 units
FDA Drug
Class II
Terminated
ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Lauderdale, FL 33316, UPC 8 54049 00358 0.
April 2, 2018
Diamond Wipes International, Inc.
51,840 pouches units
FDA Food
Class I
Terminated
Club 13 Kratom Maeng Da Red capsules; 5, 25, 50, 100, 120 capsule bottles, and Club 13 Kratom Maeng Da Red capsules in bulk bags.
March 31, 2018
Club 13 Enterprises Warehouse
7,683 units and 128 kg of capsules in bulk bags units
FDA Food
Class I
Terminated
Club 13 Kratom Maeng Da Red XS capsules; 5, 20, 25, 40, 50 capsule bottles
March 31, 2018
Club 13 Enterprises Warehouse
873 units units
FDA Food
Class I
Terminated
Club 13 Kratom Maeng Da Red powder; Pouches of 15, 30, 90, 150, 454 grams, and Club 13 Kratom Maeng Da Red powder in bulk bags.
March 31, 2018
Club 13 Enterprises Warehouse
10,237 units and 48 kg of bulk bags units
FDA Food
Class I
Terminated
Pain Out Thai Kratom all packages, all quantities
March 30, 2018
Nutrizone LLC
851 units units
FDA Food
Class I
Terminated
Cali Maeng Da Kratom all packages, all quantities
March 30, 2018
Nutrizone LLC
3000 units units
NHTSA
Ongoing
Satellite Dish May Detach from Roof
March 30, 2018
REV Recreation Group
2,055 units
FDA Food
Class III
Terminated
funky chunky Chocolate Pretzels. Pretzels, Caramel, Chocolate, Pecans. Sold in the following packaging configurations: 1. Small Bag Net Wt. 2 oz. (56g) UPC 91056-00045; 2. Large Bag Net Wt.
March 30, 2018
Funky Chunky LLC
172 lbs. units
NHTSA
Ongoing
Rear Liftgate May Open Unexpectedly
March 30, 2018
Chrysler (FCA US LLC)
12,595 units
FDA Food
Class I
Terminated
Pain Out Maeng Da Kratom all packages, all quantities
March 30, 2018
Nutrizone LLC
2487 units units
FDA Food
Class I
Terminated
Cali Thai Kratom all packages, all quantities
March 30, 2018
Nutrizone LLC
1500 units units
FDA Food
Class I
Terminated
Nirvanio Green Malay Kratom all packages, all quantities
March 30, 2018
Nutrizone LLC
Approximately 3341 units units
FDA Food
Class I
Terminated
Nirvanio Bali Kratom all packages, all quantities
March 30, 2018
Nutrizone LLC
Unknown units
NHTSA
Ongoing
Axle Spindle Weld Failure
March 30, 2018
LGS Industries Inc
132 units
FDA Food
Class I
Terminated
Nirvanio Maeng Da Kratom all packages, all quantities
March 30, 2018
Nutrizone LLC
Approximately 5517 units units
FDA Drug
Class II
Terminated
PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tube, UPC #851357003004, NDC #75940-111-60
March 30, 2018
Marcas Usa Llc
69,238 60 oz. tubes units
FDA Food
Class II
Terminated
Original Smoked Oysters, packaged in vacuum pouches, net wt. 2.25 oz. or 16 oz.. UPC 47094 20002
March 30, 2018
Taylor Shellfish Co
219/2.25 oz vacuum pouches and 28/16 oz vacuum pouches units
FDA Food
Class I
Terminated
Cali Green Malay Kratom all packages, all quantities
March 30, 2018
Nutrizone LLC
1500 units units
FDA Food
Class II
Terminated
AdvoCare Nighttime Recovery Amino Acid and Herbal Dietary Supplement Product code, P3201
March 30, 2018
AdvoCare International, LP
48,176 units units
NHTSA
Ongoing
Water Leak at Front of Vehicle
March 30, 2018
Chrysler (FCA US LLC)
12,595 units
FDA Food
Class I
Terminated
Nirvanio Special Reserve Kratom all packages, all quantities
March 30, 2018
Nutrizone LLC
4624 units units
FDA Food
Class I
Terminated
Pain Out Green Malay Kratom all packages, all quantities
March 30, 2018
Nutrizone LLC
1340 units units
NHTSA
Ongoing
Loss of Power Steering Assist Due to Corrosion
March 30, 2018
Tesla, Inc.
70,421 units
FDA Food
Class II
Terminated
AdvoCare Muscle Strength Dietary Supplement with HMB and Suma Product code, P3221
March 30, 2018
AdvoCare International, LP
15,640 units units
FDA Drug
Class II
Terminated
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
March 30, 2018
AVKARE Inc.
2135 cartons units
FDA Drug
Class III
Terminated
24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech
March 29, 2018
Akorn, Inc.
48,176 unit dose cups units
NHTSA
Ongoing
Fire Extinguisher May Be Clogged or Inoperable
March 29, 2018
LAZY DAZE, INC.
109 units
NHTSA
Ongoing
Power Steering Fluid Leak May Cause Fire
March 29, 2018
NEWMAR CORPORATION
2,139 units
CPSC
Ongoing
H-E-B Recalls Halogen Lightbulbs Due to Laceration and Fire Hazards
March 29, 2018
About 2.5 million units
CPSC
Ongoing
Octane Fitness Recalls Cross Trainers Due to Fall Hazard (Recall Alert)
March 29, 2018
About 570 units
FDA Drug
Class II
Terminated
Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
March 29, 2018
United Pacific Co Ltd
15,190 boxes units
FDA Drug
Class III
Terminated
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co.
March 29, 2018
Akorn, Inc.
56,1800 unit dose cups units