Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
High RiskFDA
Johnson & Johnson Consumer, Inc.
Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%...
Inhaled / Nasal Drugs·134,280 affected·Jul 14, 2021
High RiskFDA
Johnson & Johnson Consumer, Inc.
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Ne...
Drugs·196,380 affected·Jul 14, 2021
CriticalFDA
Qikmoov Llc
Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45...
Drugs·591 affected·Jul 14, 2021
High RiskFDA
Johnson & Johnson Consumer, Inc.
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%)...
Drugs·3,985,392 affected·Jul 14, 2021
High RiskFDA
Johnson & Johnson Consumer, Inc.
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), O...
Inhaled / Nasal Drugs·405,264 affected·Jul 14, 2021
High RiskFDA
Johnson & Johnson Consumer, Inc.
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NE...
Inhaled / Nasal Drugs·678,384 affected·Jul 14, 2021
High RiskFDA
Johnson & Johnson Consumer, Inc.
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%),...
Inhaled / Nasal Drugs·0 affected·Jul 14, 2021
CriticalFDA
Johnson & Johnson Consumer, Inc.
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%),...
Inhaled / Nasal Drugs·387,648 affected·Jul 14, 2021
High RiskFDA
Pentax Of America Inc
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Fam...
Medical Devices·28,849 affected·Jul 14, 2021
High RiskFDA
Pentax Of America Inc
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3...
Medical Devices·28,849 affected·Jul 14, 2021
High RiskFDA
Maquet Medical Systems Usa
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchange...
Medical Devices·33 affected·Jul 14, 2021
High RiskFDA
Smith & Nephew Orthopaedics Ltd. (aurora)
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
Medical Devices·47 affected·Jul 14, 2021
CriticalFDA
Micro Therapeutics Inc,
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Medical Devices·16,169 affected·Jul 13, 2021
High RiskFDA
Native Promotions, Inc
QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun...
Drugs·4,320 affected·Jul 12, 2021
High RiskFDA
Abbott Laboratories, Inc
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasm...
Diagnostic Devices·260 affected·Jul 12, 2021
RecallFDA
Stanbio Laboratory, Lp
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Diagnostic Devices·200 affected·Jul 12, 2021
High RiskFDA
W. L. Gore & Associates Inc.
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", S...
Surgical Devices·3,364 affected·Jul 12, 2021
RecallFDA
Bountiful Trading Inc
Kroger brand, Vitamin D3 125 mcg softgels, 100 count, Green HDPE packaging
Supplements·12,360 affected·Jul 9, 2021
High RiskFDA
Innoveix Pharmaceuticals Inc
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, T...
Injectable Drugs·728 affected·Jul 9, 2021
High RiskFDA
Innoveix Pharmaceuticals Inc
Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800...
Injectable Drugs·1,316 affected·Jul 9, 2021
High RiskFDA
Ortho8, Inc.
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, ...
Medical Devices·0 affected·Jul 9, 2021
High RiskFDA
Medtronic Neuromodulation
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Medical Devices·1,131 affected·Jul 9, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Steril...
Surgical Devices·152 affected·Jul 9, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommen...
Surgical Devices·178 affected·Jul 9, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recomm...
Surgical Devices·70 affected·Jul 9, 2021
High RiskFDA
Argon Medical Devices, Inc
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet o...
Medical Devices·20 affected·Jul 8, 2021
High RiskFDA
Vascutek, Ltd.
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Tri...
Medical Implants·159 affected·Jul 8, 2021
High RiskFDA
Sunrise Medical (us) Llc
Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled pers...
Medical Devices·9,865 affected·Jul 8, 2021
High RiskFDA
Aurobindo Pharma Usa Inc.
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA,...
Oral Drugs·3,800 affected·Jul 7, 2021
RecallFDA
Lnk International, Inc.
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Be...
Oral Drugs·8,472 affected·Jul 7, 2021
CriticalFDA
Baxter Healthcare Corporation
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Medical Devices·61 affected·Jul 7, 2021
High RiskFDA
5000 Years Foods, Inc.
5000 Years Foods NO MSG SLICED CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz, 64 oz, 32 oz, & 16 oz glass jars
Food·54,000 affected·Jul 6, 2021
High RiskFDA
5000 Years Foods, Inc.
5000 Years Foods NO MSG JULRADO WHOLE CABBAGE KIMCHI in 128 oz and 64 oz glass jars
Food·54,000 affected·Jul 6, 2021
High RiskFDA
5000 Years Foods, Inc.
5000 Years Foods NO MSG WHOLE CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz and 64 oz glass jars
Food·54,000 affected·Jul 6, 2021
High RiskFDA
5000 Years Foods, Inc.
5000 Years Foods NO MSG JULRADO SLICED CABBAGE KIMCHI in 128 oz, 64 oz, 32 oz, & 16 oz glass jars
Food·54,000 affected·Jul 6, 2021
High RiskFDA
5000 Years Foods, Inc.
5000 Years Foods JULRADO WHOLE CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz and 64 oz glass jars
Food·54,000 affected·Jul 6, 2021
High RiskFDA
5000 Years Foods, Inc.
5000 Years Foods WHOLE CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz and 64 oz glass jars
Food·54,000 affected·Jul 6, 2021
High RiskFDA
5000 Years Foods, Inc.
5000 Years Foods JULRADO SLICED CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz, 64 oz, 32 oz, & 16 oz glass jars
Food·54,000 affected·Jul 6, 2021
High RiskFDA
5000 Years Foods, Inc.
5000 Years Foods SLICED CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz, 64 oz, 32 oz, & 16 oz glass jars
Food·54,000 affected·Jul 6, 2021
High RiskFDA
5000 Years Foods, Inc.
5000 Years Foods WHITE WHOLE KIMCHI in 128 oz, 64 oz, and 32 oz glass jars
Food·54,000 affected·Jul 6, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29...
Diagnostic Devices·437 affected·Jul 6, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer anti...
Diagnostic Devices·787 affected·Jul 6, 2021
CriticalFDA
Lsg Sky Chefs
Circle K Chicken Salad Sandwich, 5.9 oz. (167g) clamshell packaging with tamper strip, UPC 815138013996, Manufactured By: LSG Sky Chefs S...
Meat & Poultry·42,325 affected·Jul 5, 2021
CriticalFDA
Eillien's Candies, Inc.
Blain's Farm & Fleet Select Dark Chocolate Amaretto Pecans, 12oz.
Snacks & Candy·102 affected·Jul 2, 2021
High RiskFDA
Caribbean Belize Llc
Caribbean Belize Spices Caribbean Rub, Net Wt. 3.5oz (99g) Plastic bottle with black cap Sold as single bottles
Food·9 affected·Jul 2, 2021
CriticalFDA
Kvk-tech, Inc.
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.
Oral Drugs·1,692 affected·Jul 2, 2021
High RiskFDA
The Harvard Drug Group
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose...
Oral Drugs·504 affected·Jul 2, 2021
High RiskFDA
T & R Enterprises Usa, Inc.
Vegetable egg rolls packaged either 96 3oz per case or 120 2oz per case, Manufacturer T&R Enterprises St. Louis MO.
Produce·630 affected·Jul 1, 2021