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 III Terminated

VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06,

November 25, 2019 Apothecus Pharmaceutical Corp. a) 34,417 cans b)142 cases 5,112 cans units
FDA Drug Class II Terminated

Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.

November 25, 2019 AuroMedics Pharma LLC 275,060 vials units
NHTSA Ongoing

Roof Hatch External Handle May Break/FMVSS 217

November 25, 2019 Transportation Collaborative, Inc. 9 units
NHTSA Ongoing

Unintended Activation of One Rear Brake

November 25, 2019 HARLEY-DAVIDSON MOTOR COMPANY 12,624 units
NHTSA Ongoing

LP Tank May Become Dislodged

November 25, 2019 ENTEGRA COACH 447 units
NHTSA Ongoing

Vehicle GVWR Exceeds GVWR Hitch Coupler

November 25, 2019 FOREST RIVER, INC. 328 units
FDA Drug Class II Terminated

Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA

November 25, 2019 Medisca Inc. 640,325 grams units
FDA Drug Class II Ongoing

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

November 22, 2019 Amneal Pharmaceuticals, Inc. N/A units
FDA Drug Class II Ongoing

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

November 22, 2019 Amneal Pharmaceuticals, Inc. N/A units
FDA Drug Class II Ongoing

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

November 22, 2019 Amneal Pharmaceuticals, Inc. N/A units
FDA Food Class II Terminated

Whole Foods Market Raspberry Cheesecake Italian Gelato 1 Pint (473mL) UPC 9948248024 packaged in a clear plastic container

November 22, 2019 Whole Foods Market 32,024 pints; (4,003 cartons) units
FDA Food Class II Terminated

Tuna King Tuna Saku 12-16oz 1x10lb Production date 06/13/2019 Expiration: 06/13/2021 UPC: 815838022267 Lot: 0058801

November 22, 2019 Northern Fisheries Ltd. 1 case units
FDA Food Class II Terminated

Tuna King 2-3 oz. Tuna Medallions (1 lb. packages) Production date 06/13/2019 Expiration: 06/13/2021 UPC: 815838020638 Lot: 0058797

November 22, 2019 Northern Fisheries Ltd. 805 Cases (contain 10 x 1lb packages) units
NHTSA Ongoing

Headliner Adhesive Bond Can Fail

November 22, 2019 JAGUAR LAND ROVER NORTH AMERICA, LLC 3,444 units
NHTSA Ongoing

Intermittent or Inoperative Tail Lights

November 22, 2019 FORD MOTOR COMPANY 72,718 units
FDA Food Class II Terminated

Tuna King 4 oz. and 6 oz. Tuna Steaks (frozen) Production date 06/13/2019 Expiration: 06/13/2021 4 oz. UPC 815838020645, lot 0058798; 6 oz. UPC 815838020652, lot 0058799

November 22, 2019 Northern Fisheries Ltd. 1057 cases units
FDA Drug Class II Ongoing

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e

November 22, 2019 Amneal Pharmaceuticals, Inc. N/A units
NHTSA Ongoing

Incorrect Brake Modulator Valve Installed

November 22, 2019 NAVISTAR, INC 3 units
NHTSA Ongoing

Unintended Vehicle Movement

November 22, 2019 NAVISTAR, INC 12,539 units
FDA Drug Class II Ongoing

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

November 22, 2019 Amneal Pharmaceuticals, Inc. N/A units
FDA Food Class II Terminated

Nat Strawberry Banana Flavor WONF, 20.412 kg in each 6 gallon blue HDPE jerri-can, UPC: 20358212722

November 21, 2019 Givaudan Flavours Corp 180.55kg units
CPSC Ongoing

SCARPA North America Recalls Ski Boots Due to Fall Hazard

November 21, 2019 Calzaturificio S.C.A.R.P.A. S.P.A., of Italy About 4,200 (in addition, 1,200 were sold in Canada) units
CPSC Ongoing

RESURRECTIONbeauty Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

November 21, 2019 RESURRECTIONbeauty, of Holmen, Wis. About 270 units
FDA Food Class II Terminated

Nat Bacon (smoky) Flavor WONF, 45kg in each 15 gallon blue HDPE drum, UPC: 20356152609

November 21, 2019 Givaudan Flavours Corp 360.00kg units
FDA Food Class II Terminated

Tobago Keys brand Coral Ridge Seafood Dipping Sauce 12 FL.OZ. (355 ml) and Peruvian Gold Grilling Sauce 12 FL.OZ (355 ml)

November 21, 2019 Endorphin Farms, Inc. 83 cases/12 bottles per case (996 bottles) units
FDA Food Class II Terminated

Nat Cashew Flavor Type, 11.34 kg in each 4.2 gallon blue HDPE jerri-can, UPC: 20355428593

November 21, 2019 Givaudan Flavours Corp 68.04 kg units
FDA Drug Class II Terminated

Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01

November 21, 2019 Preferred Pharmaceuticals, Inc
FDA Drug Class II Terminated

EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20,

November 21, 2019 Pacira Pharmaceuticals, Inc. 910 20 mL vials units
FDA Food Class II Terminated

Frog Hollow Holiday Fruitcake Incorrect ingredients: Organic butter, organic flour, organic sugar, organic eggs, molasses, candied orange peel, rum, dried plums, organic dried peaches. Correct l

November 21, 2019 Frog Hollow Farm 60 cakes units
FDA Food Class II Terminated

Nat Maple Flavor WONF, 20.412 kg in each 6 gallon blue HDPE jerri-can, UPC: 20357342262

November 21, 2019 Givaudan Flavours Corp 934.95kg units
NHTSA Ongoing

Improperly Installed Floor Hatches

November 21, 2019 Temsa 18 units
NHTSA Ongoing

Fuel Pump Missing Pressure Regulator

November 21, 2019 GENERAL MOTORS LLC 502 units
NHTSA Ongoing

Insufficiently Tightened Lug Nuts

November 21, 2019 Isuzu Technical Center of America, Inc. 1,926 units
NHTSA Ongoing

Ignition Switch Missing Labels

November 20, 2019 Arcimoto Inc 22 units
NHTSA Ongoing

Tire Chain Air Line Missing Pressure Protection

November 20, 2019 Marion Body Works Inc. 94 units
NHTSA Ongoing

Short Circuit May Cause Loss of Vehicle Control

November 20, 2019 Arcimoto Inc 25 units
NHTSA Ongoing

Inverter Communication May Time Out

November 20, 2019 Arcimoto Inc 18 units
CPSC Ongoing

B&B Acquisition Recalls Wintergreen Essential Oils Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Poisoning

November 20, 2019 B&B Acquisition, of Salt Lake City, Utah About 62,700 units
NHTSA Ongoing

Inverter Broadcast Exceeds Current Limit

November 20, 2019 Arcimoto Inc 22 units
FDA Drug Class II Terminated

Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit

November 20, 2019 American Health Packaging 53,619 cartons units
FDA Drug Class III Terminated

SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5514-1 UPC 8 83484 717936 6 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 7991

November 20, 2019 Idelle Labs Unknown units
FDA Drug Class I Terminated

Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05

November 20, 2019 AuroMedics Pharma LLC N/A units
FDA Drug Class III Terminated

SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 31020 5 Made in Canada and Distributed by Idelle Labs, Ltd., El P

November 20, 2019 Idelle Labs Unknown units
NHTSA Ongoing

Incorrect Information on Certification Label/FMVSS

November 20, 2019 Daimler Trucks North America LLC 2 units
FDA Food Class II Terminated

Lamb Weston Grown In Idaho Crispy Hash Brown Dices, packaged in 28 ounce poly retail bags, 6 or 12 bags packaged in a master case. UPC: 0 43301 61170 4. The retail bag has the cooking instructions.

November 20, 2019 Lamb Weston Inc total 6,062 cases (item #36003 = 1,700 cases and item #36603 = 4,362 cases) units
NHTSA Ongoing

Flex Plate Fasteners Improperly Torqued

November 20, 2019 Daimler Trucks North America LLC 30 units
FDA Drug Class III Terminated

SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83484 71794 3 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79

November 20, 2019 Idelle Labs Unknown units
FDA Drug Class III Terminated

SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX

November 20, 2019 Idelle Labs Unknown units
FDA Drug Class I Terminated

Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05

November 20, 2019 AuroMedics Pharma LLC N/A units
FDA Food Class I Terminated

DaVinci Gourmet, Classic Caramel Flavored Sauce, 128 FL OZ (1 GAL), in plastic jugs

November 20, 2019 Kerry, Inc 100 1 gal jugs units