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 Ongoing

Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-012

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Terminated

Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators)

October 22, 2019 Glenmark Pharmaceuticals Inc., USA 216,840 cartons units
FDA Drug Class II Ongoing

Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-

October 22, 2019 Sanofi-Aventis U.S. LLC
CPSC Ongoing

Federal Cartridge Recalls Blackhawk Gun Holsters Due to Injury Hazard

October 22, 2019 Federal Cartridge Company, of Manhattan, Mont. d/b/a Blackhawk, Virginia Beach, Va. About 3,100 units
FDA Drug Class I Terminated

Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 (949) 426-8622.

October 22, 2019 Green Lumber Holdings, LLC approx. 30,000 capsules units
FDA Drug Class III Terminated

Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-258

October 22, 2019 Apotex Inc. 1968 bottles units
FDA Drug Class II Ongoing

Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8

October 22, 2019 Sanofi-Aventis U.S. LLC
NHTSA Ongoing

Trailer may Detach from Tow Vehicle

October 22, 2019 AIRSTREAM, INC. 1,888 units
NHTSA Ongoing

Helmets May Not Protect Occupant/FMVSS 218

October 22, 2019 H&H Sports Protection 4,218 units
NHTSA Ongoing

Tire Tread Can Detach

October 22, 2019 SUMITOMO RUBBER INDUSTRIES, LTD. 2,286 units
FDA Drug Class II Ongoing

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Drug Class II Ongoing

Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0

October 22, 2019 Sanofi-Aventis U.S. LLC
FDA Food Class II Terminated

Fire Roasted Medium Arriba! Bacon Salsa with Real Bacon NET WT 16 OZ. UPC Code: 033907 20513 1 packaged in a clear glass jar

October 21, 2019 Riba Foods Inc 1944 units (324 cases) units
NHTSA Ongoing

Brake Actuator Mounting Washer May Fracture

October 21, 2019 HENDRICKSON USA. L.L.C. 186 units
NHTSA Ongoing

Excessive Current may Damage Fuse Holder

October 21, 2019 Polaris Inc. 31,987 units
FDA Food Class II Terminated

Crab Rangoon 1.0 oz.

October 21, 2019 T & R Enterprises USA, Inc. 600/100/1 oz/eggrolls/cases units
FDA Food Class II Terminated

Vegetable eggroll 2 oz. and 3 oz.

October 21, 2019 T & R Enterprises USA, Inc. 322/120/2 oz/eggrolls/cases and 240/72/3 oz/eggrolls/cases units
NHTSA Ongoing

Trailer may Sway when being Towed

October 21, 2019 Vac-Tron Equipment, LLC 229 units
FDA Drug Class III Terminated

PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC

October 21, 2019 Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center 19,390 syringes units
NHTSA Ongoing

Incorrect Rear Carrier Capacity Weight

October 18, 2019 HONDA (AMERICAN HONDA MOTOR CO.) 645 units
FDA Food Class II Terminated

Arroyo Grande California Cilantro; Talley Farms; Product of USA - 30 or 60 Count Individual bunches tied with Talley Farms Arroyo Grande twist tie.

October 18, 2019 Talley Farms 8436 units
FDA Food Class II Terminated

Kroger Wild Caught Sockeye Salmon Boneless, Frozen, Raw, Skin-on, not ready to eat (NRTE), individually vacuum packed in a 12 oz retail plastic bag. Salmon is a product of USA. The label is read i

October 18, 2019 Cold Locker Processing LLC 2,520 lbs. units
FDA Drug Class II Terminated

Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA exclusively for Basic Reset 260 W. Main St., Ste 103 Hendersonville, TN 37075

October 18, 2019 Basic Reset Inc. 339 bottles units
NHTSA Ongoing

PCV Valve May Separate

October 18, 2019 SUBARU OF AMERICA, INC. 205,000 units
NHTSA Ongoing

ECM Software May Cause Stall

October 18, 2019 SUBARU OF AMERICA, INC. 466,205 units
FDA Drug Class II Terminated

Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

October 18, 2019 Basic Reset Inc. 554 bottles units
NHTSA Ongoing

Propane Supply Hose may Melt

October 18, 2019 KEYSTONE RV COMPANY 5 units
FDA Drug Class II Terminated

Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

October 18, 2019 Basic Reset Inc. 391 bottles units
FDA Drug Class II Terminated

Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93

October 18, 2019 Mylan Pharmaceuticals Inc. 4,272 bottles units
FDA Drug Class II Terminated

Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, TN 37075.

October 18, 2019 Basic Reset Inc. 949 bottles units
NHTSA Ongoing

PCV Valve May Separate

October 18, 2019 SUBARU OF AMERICA, INC. 251 units
CPSC Ongoing

Soft Play Recalls Spider Climb Playground Climbers Due to Fall Hazard (Recall Alert)

October 18, 2019 Soft Play LLC, of Huntersville, N.C. About 200 units
FDA Drug Class II Terminated

BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

October 18, 2019 Basic Reset Inc. 25 bottles units
FDA Drug Class II Terminated

BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

October 18, 2019 Basic Reset Inc. 25 bottles units
NHTSA Ongoing

Improper Warning Labels/FMVSS 213

October 18, 2019 Dorel China America, Inc. 28,800 units
FDA Drug Class II Terminated

Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

October 18, 2019 Basic Reset Inc. 98 bottles units
FDA Drug Class II Terminated

Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075

October 18, 2019 Basic Reset Inc. 1000 bottles units
NHTSA Ongoing

Missing Backup Camera/FMVSS 111

October 18, 2019 COLLINS BUS CORPORATION 24 units
NHTSA Ongoing

Stabilizer Bracket May Break

October 18, 2019 FOREST RIVER, INC. 14 units
FDA Drug Class II Terminated

BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

October 18, 2019 Basic Reset Inc. 25 bottles units
FDA Drug Class II Terminated

Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

October 18, 2019 Basic Reset Inc. 598 bottles units
FDA Drug Class II Terminated

Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN.

October 18, 2019 Basic Reset Inc. N/A units
NHTSA Ongoing

Water Heater May Scald Operator

October 18, 2019 Starcraft RV 5 units
NHTSA Ongoing

D-Cylinder Oxygen Tank Bracket May Loosen

October 17, 2019 Halcore Group, Inc. 11 units
NHTSA Ongoing

Air Hose Beam Clip may Detach

October 17, 2019 HYUNDAI TRANSLEAD 34,960 units
NHTSA Ongoing

VCU May Activate Anti-roll Back

October 17, 2019 CUMMINS, INC. 104 units
FDA Drug Class III Terminated

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540,

October 17, 2019 Sandoz, Inc 76,644 bottles units