Product Recalls in 2021

3,955 recalls issued this year

219

CPSC

1,491

FDA Food

1,152

FDA Drug

1,093

NHTSA

FDA Drug Class II Terminated

Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11

July 29, 2021 Teva Pharmaceuticals USA 2,091 vials units
FDA Food Class II Terminated

Mexican Chocolate, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint container only: 00856962005023.

July 29, 2021 Full Tilt Ice Cream, LLC 500 pints and 100 tubs units
FDA Drug Class II Terminated

GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Ba

July 29, 2021 Novel Laboratories, Inc. d.b.a LUPIN 20,814 bottles units
FDA Drug Class II Terminated

Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01

July 29, 2021 Teva Pharmaceuticals USA 6,184 vials units
FDA Drug Class II Terminated

Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01

July 29, 2021 Teva Pharmaceuticals USA 476,275 vials units
FDA Drug Class II Terminated

Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01

July 29, 2021 Teva Pharmaceuticals USA 3,067 vials units
FDA Drug Class II Terminated

Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01

July 29, 2021 Teva Pharmaceuticals USA 16,644 vials units
FDA Drug Class II Terminated

Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmac

July 29, 2021 PAI Holdings, LLC. dba Pharmaceutical Associates Inc a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case) units
FDA Drug Class II Terminated

Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08

July 29, 2021 PAI Holdings, LLC. dba Pharmaceutical Associates Inc 400 cases (12 bottles/case) units
FDA Drug Class II Terminated

Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04

July 29, 2021 The Harvard Drug Group 1,632 cartons units
FDA Drug Class II Ongoing

Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59

July 29, 2021 Teligent Pharma, Inc. 7488 bottles units
FDA Drug Class III Terminated

Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.

July 29, 2021 Teligent Pharma, Inc. 114,456 tubes units
FDA Drug Class II Terminated

Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product

July 29, 2021 Sun Pharmaceutical Industries Inc. 2856 bottles units
FDA Food Class II Terminated

Mint Chip, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.

July 29, 2021 Full Tilt Ice Cream, LLC 75 tubs units
FDA Drug Class II Terminated

Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01

July 29, 2021 Teva Pharmaceuticals USA 4,712 vials units
FDA Drug Class II Terminated

Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA

July 29, 2021 Teva Pharmaceuticals USA 50,713 vials units
FDA Food Class II Terminated

All The Chocolate, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.

July 29, 2021 Full Tilt Ice Cream, LLC 150 tubs units
FDA Food Class II Terminated

Backyard mint chip, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and and 3 gallon tubs. UPC on pint container: 00856962005054.

July 29, 2021 Full Tilt Ice Cream, LLC 500 pints units
NHTSA Ongoing

Blank LCD Display/FMVSS 101

July 29, 2021 Kia Motors America 5,143 units
FDA Drug Class II Terminated

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01

July 29, 2021 Teva Pharmaceuticals USA 4,992 bottles units
FDA Drug Class II Terminated

Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01

July 29, 2021 Teva Pharmaceuticals USA 2,199 vials units
FDA Food Class II Terminated

Ube, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.

July 29, 2021 Full Tilt Ice Cream, LLC 75 tubs units
FDA Drug Class II Terminated

Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01

July 29, 2021 Teva Pharmaceuticals USA 25,653 vials units
FDA Food Class II Terminated

Coffee Oreo, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.

July 29, 2021 Full Tilt Ice Cream, LLC 100 tubs units
FDA Drug Class II Terminated

Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01

July 29, 2021 Teva Pharmaceuticals USA 62,358 vials units
FDA Drug Class II Terminated

Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01

July 29, 2021 Teva Pharmaceuticals USA 4,249 vials units
FDA Food Class II Terminated

Strawberry, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint container: 00856962005290.

July 29, 2021 Full Tilt Ice Cream, LLC 100 tubs units
FDA Food Class II Terminated

Huckleberry Chip, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.

July 29, 2021 Full Tilt Ice Cream, LLC 50 tubs units
NHTSA Ongoing

Fuel Hose Leak

July 29, 2021 NEW FLYER OF AMERICA, INC. 30 units
NHTSA Ongoing

Spare Tire is Incorrect Size

July 29, 2021 GENERAL MOTORS LLC 86 units
FDA Food Class II Terminated

Peanut Butter Chip, Full Tilt Ice Cream brand, packaged in 3 gallon tubs. No UPC.

July 29, 2021 Full Tilt Ice Cream, LLC 50 tubs units
NHTSA Ongoing

Brake System Calibrated Incorrectly

July 29, 2021 GENERAL MOTORS LLC 2 units
FDA Food Class II Terminated

Dark Chocolate, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint container only: 00856962005276.

July 29, 2021 Full Tilt Ice Cream, LLC 500 pints and 100 tubs units
FDA Food Class II Terminated

Vanilla Bean, Full Tilt Ice Cream, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint containers only: 00856962005283

July 29, 2021 Full Tilt Ice Cream, LLC 500 pints and 100 tubs units
FDA Drug Class II Terminated

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01

July 29, 2021 Teva Pharmaceuticals USA 4,587 bottles units
FDA Drug Class II Terminated

Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1

July 29, 2021 Teva Pharmaceuticals USA 34,100 vials units
FDA Drug Class II Terminated

Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16

July 29, 2021 PAI Holdings, LLC. dba Pharmaceutical Associates Inc 75 cases (6 bottles/case) units
FDA Drug Class II Terminated

Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC

July 29, 2021 Teva Pharmaceuticals USA 193,845 vials units
FDA Drug Class II Terminated

Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01

July 29, 2021 Teva Pharmaceuticals USA 434,229 vials units
CPSC Ongoing

Specialized Bicycle Components Recalls Electric Mountain Bike Battery Packs Due to Fire and Burn Hazards (Recall Alert)

July 29, 2021 About 2,500 units
CPSC Ongoing

Generac Recalls Portable Generators Due to Finger Amputation and Crushing Hazards

July 29, 2021 Generac Power Systems, of Waukesha, Wis. About 321,160 (In addition, 4,575 in Canada) units
CPSC Ongoing

Children's Sleepwear Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Sold Exclusively by Zoetop Business Co. Ltd. at www.SHEIN.com (Recall Alert)

July 29, 2021 Puning Han Huini, of China About 2,320 units
FDA Drug Class II Terminated

Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91

July 29, 2021 Teva Pharmaceuticals USA 42,046 vials units
FDA Drug Class II Terminated

Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01

July 29, 2021 Teva Pharmaceuticals USA 20,800 vials units
FDA Drug Class II Terminated

DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13

July 29, 2021 Teva Pharmaceuticals USA 1,351 vials units
FDA Drug Class II Terminated

Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01

July 29, 2021 Teva Pharmaceuticals USA 12,698 vials units
FDA Food Class II Terminated

Thai Tea, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint container: 00856962005290.

July 29, 2021 Full Tilt Ice Cream, LLC 500 pints and 50 tubs units
FDA Drug Class II Terminated

Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, P

July 29, 2021 Teva Pharmaceuticals USA 16,226 vials units
FDA Drug Class II Terminated

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Par

July 29, 2021 Teva Pharmaceuticals USA 9,655 bottles units
CPSC Ongoing

Birkenstock USA Recalls Kids' Mogami Sandals Due to Choking Hazard

July 28, 2021 About 15,200 (in addition, about 27 pairs were sold in Canada) units