Product Recalls in 2018

4,897 recalls issued this year

258

CPSC

1,977

FDA Food

1,681

FDA Drug

981

NHTSA

NHTSA Ongoing

Fuel Diaphragm Cracks may cause Fuel Leak

June 27, 2018 Toyota Motor Engineering & Manufacturing 114,998 units
NHTSA Ongoing

Incorrect Rim Size on Federal Label

June 27, 2018 KEYSTONE RV COMPANY 20 units
FDA Drug Class III Terminated

Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30

June 27, 2018 Aidarex Pharmaceuticals LLC 25, 30-count bottles units
NHTSA Ongoing

Tire Strength Does not Meet Standards/FMVSS 119

June 26, 2018 Achieva Rubber Corp. 2,900 units
FDA Drug Class III Terminated

Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distribut

June 26, 2018 MAJOR PHARMACEUTICALS 3,397 cartons units
CPSC Ongoing

Huish Outdoors Recalls Scuba Diving Regulators Due to Drowning Hazard

June 26, 2018 About 4,500 (In addition, 330 were sold in Canada) units
NHTSA Ongoing

Passenger Frontal Air Bag Inflator May Explode

June 26, 2018 Volkswagen Group of America, Inc. 237,947 units
NHTSA Ongoing

Curtain Air Bags may not Deploy Properly/FMVSS 226

June 26, 2018 MAZDA NORTH AMERICAN OPERATIONS 682 units
CPSC Ongoing

Baccus Recalls Stanley Workbench LED Light and Power Stations Due to Shock and Electrocution Hazards (Recall Alert)

June 26, 2018 Hairishen Electric (Shenzhen) Co. Ltd., of China About 20,000 units
FDA Drug Class I Terminated

Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3.

June 26, 2018 World Organix, LLC 164 2oz bottles units
FDA Drug Class I Terminated

Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed by World Organix LLC Las Vegas Nevada. UPC#7 14983 56525 7

June 26, 2018 World Organix, LLC 681 12 mL-bottle units
FDA Drug Class I Terminated

Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist. by World Organix LLC, Las Vegas Nevada UPC# 6 02401 88900 2

June 26, 2018 World Organix, LLC 545 50-count pouches, 27,250 capsules units
FDA Drug Class I Terminated

Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3

June 26, 2018 World Organix, LLC 789 50-count pouches, total of 39,450 capsules units
FDA Drug Class III Terminated

Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed

June 26, 2018 MAJOR PHARMACEUTICALS 5,933 cartons units
NHTSA Ongoing

Trailer Brakes May Not Be Applied

June 26, 2018 Syncro Corporation 1,944 units
NHTSA Ongoing

Electrical Short may Result from Incorrect Wiring

June 26, 2018 REV Recreation Group 5 units
FDA Drug Class I Terminated

Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organix LLC, Las Vegas Nevada UPC# 7 11583 27057 4

June 26, 2018 World Organix, LLC 553 50-count pouch, 27,650 capsules units
FDA Drug Class II Terminated

Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500

June 25, 2018 La Vita Compounding Pharmacy, LLC 191 vials units
FDA Drug Class III Terminated

Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [6

June 25, 2018 American Health Packaging 1285 cartons (cartons of 100 individual unit doses) units
FDA Drug Class II Terminated

Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500

June 25, 2018 La Vita Compounding Pharmacy, LLC 17,610 mL total dispensed in 10 mL and 30 mL vials units
NHTSA Ongoing

Random Characters on Certification Label

June 25, 2018 HONDA (AMERICAN HONDA MOTOR CO.) 13 units
NHTSA Ongoing

Wheelchair Lift may Raise too High/FMVSS 403

June 25, 2018 RICON CORPORATION 4,262 units
FDA Drug Class II Terminated

Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500

June 25, 2018 La Vita Compounding Pharmacy, LLC 19,040 mL total dispensed in 10 mL and 30 mL vials units
NHTSA Ongoing

Aerial Ladder may Crack

June 25, 2018 E-One Incorporated 8 units
NHTSA Ongoing

Air Bags/Seat Belt Pretensioners may be Disabled

June 25, 2018 TRW AUTOMOTIVE INC 3,619,897 units
NHTSA Ongoing

Solenoid Corrosion may Hinder Fire Fighting

June 25, 2018 Spartan Motors USA 1,243 units
NHTSA Ongoing

Water may Enter the Trailer Tow Module

June 25, 2018 TRIPLE E RECREATIONAL VEHICLES 9 units
FDA Food Class III Terminated

Amino Life brand Product - L-Leucine Instant Sunflower 25 Kgs Fiber carton double layer polyethylene bag as liner

June 22, 2018 Prinova US LLC 1775 kgs units
NHTSA Ongoing

Fuel Pump Flange Weld may Fracture

June 22, 2018 Robert Bosch LLC 6,493 units
FDA Food Class III Terminated

Prinova brand Product - MRI Amintoten Strawberry Powder 25 Kgs Fiber carton double layer polyethylene bag as liner

June 22, 2018 Prinova US LLC 3350 kgs units
FDA Food Class II Terminated

Sparkling ICE Cherry Limeade Naturally Flavored Sparking Water, packaged in a PET bottles with a plastic cap, Net Wt. 17 ounces (502.8 ml). UPC code on bottle: 0 16571 95084 2. UPC on Single Pack

June 22, 2018 Talking Rain Beverage Co Inc 684,977 cases (single pack = 214,311 cases and variety pack = 470,666 cases) units
FDA Food Class III Terminated

Amino Life brand Product - BCAA 2:1:1 Instant Sunflower 25 Kgs Fiber carton double layer polyethylene bag as liner

June 22, 2018 Prinova US LLC 1225 kgs units
FDA Drug Class II Terminated

Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.

June 22, 2018 Akorn, Inc. 89,507 vials units
FDA Food Class III Terminated

Prinova brand Product - Reginator NV (41825) 25 Kgs Fiber carton double layer polyethylene bag as liner

June 22, 2018 Prinova US LLC 3000 kgs units
NHTSA Ongoing

Air in the Anti-Lock Brake System

June 22, 2018 INDIAN MOTORCYCLE COMPANY 4,185 units
FDA Food Class II Terminated

Brew Dr. Kombucha Clear Mind, item Code: FCG0002, 6 glass bottles per case, net volume: 32 FL OZ (946 ML). UPC: 51107 00369. The bottle's label is read in parts: "***CLEAR MIND***INGREDIENTS: Brewe

June 22, 2018 BREW DR KOMBUCHA LLC 3,150 bottles (525 cases) units
NHTSA Ongoing

Side Air Bags may not Deploy Properly/FMVSS 214

June 22, 2018 BUGATTI 2 units
FDA Drug Class II Terminated

eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Co

June 22, 2018 Eb5 Corporation 4,632 tubes units
NHTSA Ongoing

Turn Signal Flashing Rate Incorrect/FMVSS 108

June 22, 2018 Gillig LLC 25,579 units
NHTSA Ongoing

Fuel Line Damage Causing Fuel Leak

June 21, 2018 NAVISTAR, INC 19 units
NHTSA Ongoing

Improperly Torqued Brake Caliper Mounting Bolts

June 21, 2018 Daimler Trucks North America LLC 18,105 units
NHTSA Ongoing

Incorrect PSI on Federal Placard/FMVSS 110

June 21, 2018 FOREST RIVER, INC. 301 units
NHTSA Ongoing

Wheel Guards may Melt from Brake Heat

June 21, 2018 Simard Suspensions inc 89 units
NHTSA Ongoing

Flame on Stove May be Inverted

June 21, 2018 FOREST RIVER, INC. 435 units
FDA Food Class I Terminated

Honey Mama's Oregon Peppermint Cacao-Nectar Bar wrapped in quilon parchment paper with a sticker label. Net wt. 2.5 oz, 3" x 3" bar, 12 bars to a cardboard display case and 12 display cases to a cardb

June 21, 2018 Nectar Foods LLC 79 display cases or sleeves (948 bars total) units
NHTSA Ongoing

Water may Enter the Trailer Tow Module

June 21, 2018 THOR MOTOR COACH 158 units
FDA Food Class III Terminated

Blue Bell Ice Cream, Brand Homemade Vanilla Flavored, 3 FL OZ (88 mL), Cups, 24 per box, This Unit Not Labeled For Retail Sale

June 21, 2018 Blue Bell Creameries, L.P. 136 boxes units
FDA Drug Class I Terminated

Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

June 20, 2018 Gaia Ethnobotanical LLC unknown units
NHTSA Ongoing

Driver's Frontal Air Bag Inflator May Explode

June 20, 2018 Volkswagen Group of America, Inc. 2,564 units
FDA Drug Class I Terminated

Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com

June 20, 2018 Gaia Ethnobotanical LLC unknown units