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
Thermo Fisher Scientific
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Medical Devices·19 affected·Feb 1, 2021
High RiskFDA
Kewpie Trading Europe B.v.
Kewpie Deep Roasted Sesame Dressing; 8 oz.(263ml/243g) and 64 oz. (1893 ml/1950g) bottles (glass and plastic) Refrigerate after openin...
Food·8 affected·Jan 31, 2021
High RiskFDA
Renaissance Food Group, Llc
BUFFALO STYLE CHICKEN Sliders NET WT. 5OZ (141g) Ingredients: Tuna Salad*** CONTAINS: EGG, FISH (TUNA), MILK, WHEAT Distributed By Renais...
Dairy·226 affected·Jan 29, 2021
RecallFDA
Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc
Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, IN...
Oral Drugs·17,664 affected·Jan 29, 2021
High RiskFDA
Draeger Medical, Inc.
ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conducti...
Respiratory Devices·25 affected·Jan 29, 2021
High RiskFDA
Getinge Group Logistics America, Llc
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients...
Respiratory Devices·144 affected·Jan 29, 2021
High RiskFDA
Stryker Communications
S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series F...
Medical Devices·1,393 affected·Jan 29, 2021
High RiskFDA
Draeger Medical, Inc.
VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduct...
Respiratory Devices·150 affected·Jan 29, 2021
High RiskFDA
Glanbia Performance Nutrition (manufacturing), Inc
think! Protein + Fiber Oatmeal, Farmer's Market Berry Crumble bowl 1.76 oz. individual unit UPC 753656711836 also sold in retail 6 pack ...
Produce·81,906 affected·Jan 28, 2021
High RiskFDA
Treehouse Foods
Happy Belly Mayo Light Mayonnaise 30 FL OZ Plastic Jar Item B08B6T9RC6
Food·30 affected·Jan 28, 2021
CriticalFDA
Dole Fresh Vegetables Inc
Dole Endless Summer Salad Kit; 13 oz. bag UPC: 0-71430-01073-0 Contains Milk, Wheat Distributed by Dole Fresh Vegetables, Inc., M...
Dairy·2,828 affected·Jan 28, 2021
RecallFDA
Accord Healthcare, Inc.
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durh...
Injectable Drugs·502 affected·Jan 28, 2021
High RiskFDA
Olympus Corporation Of The Americas
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equip...
Surgical Devices·1,564 affected·Jan 28, 2021
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Medical Devices·1,225 affected·Jan 28, 2021
High RiskFDA
Biomerieux Inc
VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test,...
Medical Implants·6,777 affected·Jan 28, 2021
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Medical Devices·1,650 affected·Jan 28, 2021
High RiskFDA
Baxter Healthcare Corporation
Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used f...
Medical Devices·35,175 affected·Jan 28, 2021
High RiskFDA
Nongshim America, Inc.
Nongshim brand Shin Ramyun; Sold in the following packaging configurations: 4.2 oz, individual bags UPC 031146150601 16 count box (16 x ...
Food·4,689 affected·Jan 27, 2021
High RiskFDA
Bryant Ranch Prepack, Inc. Dba Brp Pharmaceuticals
Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 191...
Oral Drugs·12 affected·Jan 27, 2021
CriticalFDA
Bryant Ranch Prepack, Inc. Dba Brp Pharmaceuticals
Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-...
Oral Drugs·35 affected·Jan 27, 2021
CriticalFDA
Meitheal Pharmaceuticals Inc
Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose...
Injectable Drugs·34,860 affected·Jan 27, 2021
High RiskFDA
Johnson & Johnson Surgical Vision Inc
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
Medical Devices·27 affected·Jan 27, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supportin...
Surgical Devices·37 affected·Jan 27, 2021
CriticalFDA
Maine Grains, Inc
Maine Grains Inc. brand Organic Yellow Peas sold between 10/17/2019 and 11/1/2020; product was packaged in 25lb bulk bags, 12 x 1lb cases...
Food·2,000 affected·Jan 26, 2021
CriticalFDA
Hong Thai Foods Corp
Golden Boy Custard Muffin Banana 220 grams/7.76 ounce packages
Food·19 affected·Jan 26, 2021
High RiskFDA
Biofire Diagnostics, Llc
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Produc...
Medical Devices·21,922 affected·Jan 26, 2021
High RiskFDA
Goodman Food Products Texas Inc
O Organics Plant Based Mushroom and Veggie Organic Burger Patties, 10 oz Package of 4/ 2.5oz patties packaged in cardboard box
Food·1,046 affected·Jan 25, 2021
High RiskFDA
Wildtree Inc.
"Wildtree***Leslies Chili Blend***Organic & Gluten Free***Net Wt. 3.7 oz. ***Distributed by: Wildtree"
Food·273 affected·Jan 25, 2021
High RiskFDA
Nostrum Laboratories Inc
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, In...
Oral Drugs·7,071 affected·Jan 25, 2021
High RiskFDA
Corin Ltd
Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Cer...
Medical Implants·23 affected·Jan 25, 2021
High RiskFDA
Corin Ltd
Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Cera...
Medical Implants·23 affected·Jan 25, 2021
High RiskFDA
Medline Industries Inc
RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It ...
Medical Devices·4 affected·Jan 25, 2021
High RiskFDA
Deroyal Industries Inc
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs includin...
Cardiac Devices·1,084 affected·Jan 25, 2021
High RiskFDA
Deroyal Industries Inc
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom su...
Surgical Devices·309 affected·Jan 25, 2021
High RiskFDA
Deroyal Industries Inc
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including stern...
Cardiac Devices·776 affected·Jan 25, 2021
High RiskFDA
Bickel's Snack Foods Inc
Butter Flavored Popcorn Artificially Flavored 8oz. UPC:7017306021
Dairy·504 affected·Jan 22, 2021
High RiskFDA
World Finer Foods, Inc.
Reese Hollandaise Sauce packaged in glass jars 7.5 oz UPC: 7067060108
Food·1,600 affected·Jan 22, 2021
High RiskFDA
Ascend Laboratories Llc
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 0...
Oral Drugs·14,205 affected·Jan 22, 2021
High RiskFDA
Ascend Laboratories Llc
Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 01...
Oral Drugs·23,436 affected·Jan 22, 2021
High RiskFDA
Raysearch America Inc
Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, ...
Medical Devices·5 affected·Jan 22, 2021
CriticalFDA
Frito-lay, Inc. Headquarters
RUFFLES "PARTY SIZE" ORIGINAL POTATO CHIPS 13 1/2 oz. UPC 028400034005 packaged in flexible bags
Snacks & Candy·50 affected·Jan 21, 2021
High RiskFDA
Door County Coffee & Tea Co., Inc.
Door County Coffee & Tea Co. French Vanilla Flavored Cappuccino. 10 Single Serve cups .51 oz (14g)/EA. Net Wt. 5.1 oz. (144g)
Beverages·3,325 affected·Jan 21, 2021
High RiskFDA
Stanley Specialty Pharmacy Compounding And Wellness Center
Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy 3120 Latrob...
Topical Drugs·4,400 affected·Jan 21, 2021
RecallFDA
Lupin Pharmaceuticals Inc.
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuti...
Oral Drugs·46,479 affected·Jan 21, 2021
High RiskFDA
G & H Wire Company
Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber th...
Medical Devices·371 affected·Jan 21, 2021
High RiskFDA
Steris Corporation
OT1000 Series Orthopedic Surgical Tables
Surgical Devices·272 affected·Jan 21, 2021
RecallFDA
House-autry Mills, Inc
HOUSE AUTRY TARTAR SAUCE NET WT 9 OZ (255g) DISTSRIBUTED BY House -Autry Mills, Inc. Four Oaks, NC 27524 UPC 0 73484 60013 4
Food·3,856 affected·Jan 20, 2021
High RiskFDA
Aurobindo Pharma Usa Inc.
Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East ...
Oral Drugs·1,296 affected·Jan 20, 2021