Product Recalls in 2020

3,187 recalls issued this year

257

CPSC

1,117

FDA Food

930

FDA Drug

883

NHTSA

CPSC Ongoing

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

June 4, 2020 Capstone Holdings LLC, dba Simply Earth, of Waldo, Wis. About 2,935 units
CPSC Ongoing

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

June 4, 2020 About 900 units
FDA Drug Class III Terminated

Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01

June 4, 2020 SOMERSET THERAPEUTICS LLC 22,788 bottles units
NHTSA Ongoing

Brake Line Routing May Cause Wear and Fluid Leak

June 4, 2020 Braun Ambulances 31 units
FDA Drug Class II Terminated

Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1

June 3, 2020 WALKER EMULSIONS INC N/A units
FDA Drug Class II Terminated

Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-

June 3, 2020 WALKER EMULSIONS INC N/A units
NHTSA Ongoing

Front Seat Wiring Harnesses Routed Incorrectly

June 3, 2020 Daimler Vans USA, LLC 11,013 units
FDA Food Class II Terminated

TOUFAYAN BAKERIES SMART POCKETS EVERYTHING 6 COUNT NET WT 7.4 OZ. (210 g), UPC 0 7312400792 7. 12 packages per case. Product expiration date or shelf life date is not added to package by firm but may

June 3, 2020 Toufayan Bakery, Inc. 10,804 cases. 12 packages/case. units
FDA Drug Class II Terminated

Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3

June 3, 2020 Yusef Manufacturing Laboratories, LLC 2,558 pieces units
FDA Drug Class II Terminated

Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097

June 3, 2020 A.P. Deauville, LLC 82,800 bottles units
NHTSA Ongoing

Fuel Line Quick Connector May Leak

June 2, 2020 BENTLEY MOTORS, INC. 1,892 units
FDA Food Class II Terminated

Adams Reserve Sweet & Spicy Seafood Salmon NEY WT 2.5 OZ (73g) UPC code 4313 04950.

June 2, 2020 Adams Extract & Spice LLC 1,389 units units
FDA Drug Class II Terminated

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Di

June 2, 2020 Teva Pharmaceuticals USA a) 15,329 bottles and b) 137 bottles units
FDA Drug Class II Terminated

Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna

June 2, 2020 Teva Pharmaceuticals USA a) 92,793 bottles and b) 4,824 bottles units
FDA Drug Class II Terminated

Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC 612520481094

June 1, 2020 WORLD EVENT PROMOTIONS, LLC 14050 bottles units
NHTSA Ongoing

Axles and Tires have Incorrect Load Rating

June 1, 2020 KEYSTONE RV COMPANY 41 units
NHTSA Ongoing

Sidewall Separation/FMVSS 139

June 1, 2020 Vee Tyre and Rubber Co., Ltd. 522 units
NHTSA Ongoing

Fuel Pump May Fail

May 29, 2020 HONDA (AMERICAN HONDA MOTOR CO.) 135,995 units
FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharma

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units
NHTSA Ongoing

Unintentional Release of Primary Hood Latch

May 29, 2020 NISSAN NORTH AMERICA, INC. 1,831,818 units
FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units
FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceut

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units
FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Phar

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units
NHTSA Ongoing

ABS Malfunction Indicator May Not Light/FMVSS 105

May 29, 2020 GENERAL MOTORS LLC 12,200 units
FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Ph

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units
FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units
FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units
FDA Drug Class II Terminated

Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, ca

May 29, 2020 Pfizer Inc. 94320 units units
NHTSA Ongoing

Underrated Safety Chains May Break

May 29, 2020 FOREST RIVER, INC. 122 units
NHTSA Ongoing

Brake Line Routing May Cause Wear and Fluid Leak

May 29, 2020 Braun Ambulances 10 units
FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharm

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units
FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. 192 units
FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units
FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units
FDA Food Class II Terminated

Healthy Choice Pesto and Egg bowls labeled in the following ways: 1) (for the US market) Healthy Choice Power Bowls Morning Pesto & Egg White Scramble, Net Wt. 7.2 OZ (204 g); UPC 0-72655-00083-4 2)

May 29, 2020 ConAgra Foods Inc 8,780 cases units
FDA Drug Class II Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05

May 29, 2020 Amneal Pharmaceuticals of New York, LLC. N/A units
NHTSA Ongoing

Front Brake Hoses May Contact Fender Liners

May 28, 2020 THOR MOTOR COACH 566 units
NHTSA Ongoing

Bluetooth Brake Control Functionality

May 28, 2020 Horizon Global 2,285 units
FDA Drug Class II Terminated

Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.

May 28, 2020 Lupin Pharmaceuticals Inc. 4,224 bottles units
FDA Drug Class II Terminated

Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-42

May 28, 2020 Glaxosmithkline Consumer Healthcare Holdings 119,364 bottles units
NHTSA Ongoing

Incorrect Tire Information on Certification Label

May 28, 2020 KEYSTONE RV COMPANY 9 units
NHTSA Ongoing

Brake Line Routing May Cause Wear and Fluid Leak

May 28, 2020 Frazer 76 units
NHTSA Ongoing

Non-Compliant Brake Hoses/FMVSS 106

May 28, 2020 Arcimoto Inc 98 units
FDA Drug Class II Terminated

Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41

May 28, 2020 Glaxosmithkline Consumer Healthcare Holdings 629,796 bottles units
FDA Drug Class III Terminated

Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.

May 28, 2020 AVKARE Inc. 4124 bottles units
FDA Drug Class II Terminated

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-

May 28, 2020 QuVa Pharma, Inc. 648 bags units
FDA Drug Class II Terminated

Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41

May 28, 2020 Glaxosmithkline Consumer Healthcare Holdings 151,344 bottles units
FDA Drug Class II Terminated

Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0095-41

May 28, 2020 Glaxosmithkline Consumer Healthcare Holdings 1,631,700 bottles & 27,300 Twin-Pack botles units
NHTSA Ongoing

Wireless Controller Sleep Mode Disabled

May 27, 2020 Akron Brass Company 53 units
NHTSA Ongoing

Front Facing Camera Improperly Calibrated

May 27, 2020 FORD MOTOR COMPANY 24 units