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
www.fda.gov →Official Site

Have an unsafe medication, device, or food to report?

Filing a report with the FDA is free and takes a few minutes. Consumer reports drive future recalls and help the agency identify safety patterns.

How to report to FDA →
68,659 recalls
High RiskFDA
Adler Micromed, Inc.
Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. D...
Surgical Devices·1,858 affected·Apr 23, 2021
High RiskFDA
Coopersurgical, Inc.
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not m...
Medical Devices·6 affected·Apr 23, 2021
High RiskFDA
Philips North America Llc
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
Diagnostic Devices·156 affected·Apr 23, 2021
High RiskFDA
Wolfies Group Inc
Wolfie's Crunchy Cheddar & Jalapeno Peanuts Packaged in a Rice Paper Stand Up Pouch with Clear Poly Plastic Bag inside 5oz - 12 bags per ...
Food·266 affected·Apr 22, 2021
High RiskFDA
Abbott Laboratories Inc. (st Jude Medical)
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Medical Devices·318 affected·Apr 22, 2021
CriticalFDA
Jule's Foods
Jule's Brie Ranch Dressing with Cashews. Net Wt.12 oz. (335 mL) Keep Refrigerated UPC 860388001552
Food·8,603 affected·Apr 21, 2021
CriticalFDA
Jule's Foods
Jule's Artichoke Spinach Dip, Net Wt.8 oz. (227 G) Keep Refrigerated UPC 860388001552
Produce·8,603 affected·Apr 21, 2021
CriticalFDA
Jule's Foods
Jule's Truffle Cashew Brie, Net Wt. 6 oz.(1.70g) Keep Refrigerated. UPC 860388001514
Food·8,603 affected·Apr 21, 2021
CriticalFDA
Basic Grain Products Inc
Caramel Rice Cakes 6.56oz (186g) 12 units per case 14 rice cakes per packaging Brands: Kroger Brand and Stop & Shop Brand
Bakery & Grains·3,069 affected·Apr 21, 2021
CriticalFDA
Jule's Foods
Jule's Cashew Brie (Classic) Net Wt. 6 oz. (1.70g) Keep Refrigerated. UPC 860388001507
Food·8,603 affected·Apr 21, 2021
RecallFDA
Heritage Pharmaceuticals Inc
Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-...
Oral Drugs·408 affected·Apr 21, 2021
High RiskFDA
Raysearch Laboratories Ab
RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8...
Medical Devices·13,722 affected·Apr 21, 2021
High RiskFDA
Potomac River Group, Corp.
RAPTAR Laser Range Finders
Medical Devices·62 affected·Apr 21, 2021
High RiskFDA
Dentech Corp.
Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
Medical Devices·87,842 affected·Apr 21, 2021
High RiskFDA
Pentax Of America Inc
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide o...
Medical Devices·108 affected·Apr 21, 2021
RecallFDA
Microvention Inc.
VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewi...
Surgical Devices·0 affected·Apr 21, 2021
RecallFDA
Microvention Inc.
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewi...
Surgical Devices·0 affected·Apr 21, 2021
High RiskFDA
Anodyne Surgical
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, R...
Surgical Devices·8,452 affected·Apr 21, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to T...
Diagnostic Devices·22,550 affected·Apr 21, 2021
High RiskFDA
Innovative Tomography Product Gmbh
Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 1...
Medical Devices·0 affected·Apr 21, 2021
High RiskFDA
Innovative Tomography Product Gmbh
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length ...
Medical Devices·0 affected·Apr 21, 2021
CriticalFDA
Forest Mushroom Food Inc.
Guan's Enoki Mushroom - Champigons d'enoki; Net Wt./ Poids Net 200 g/ 7.05 oz.; 25 individual packages per box. Distributed by Guan's ...
Food·3,428 affected·Apr 20, 2021
High RiskFDA
Faribault Foods
O Organics Organic Black Beans, 15 oz. can, UPC 0-79893-40610-7 Distributed by Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 94566-0009...
Food·619,761 affected·Apr 20, 2021
High RiskFDA
Faribault Foods
S&W Organic Black Beans, 15 oz. can, Distributed by: Faribault Foods, 3401 Park Ave NW, Faribault, MN 55021.
Food·619,761 affected·Apr 20, 2021
High RiskFDA
Faribault Foods
O Organics Organic Chili Beans, 15 oz. can, UPC 0-79893- 40617-6 Distributed by Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 94566-000...
Food·619,761 affected·Apr 20, 2021
RecallFDA
Lopez Gonzalez Santana Corporation
BTREX PLUS, Dietary Supplement 100 Caplets
Supplements·311 affected·Apr 20, 2021
RecallFDA
Genentech Inc
Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech,...
Oral Drugs·2,627 affected·Apr 20, 2021
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution...
Drugs·707,050 affected·Apr 20, 2021
High RiskFDA
Medivators, Inc.
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidne...
Medical Devices·1,381 affected·Apr 20, 2021
High RiskFDA
Elekta, Inc.
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Medical Devices·40 affected·Apr 20, 2021
High RiskFDA
Willowwood Global Llc
Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expu...
Medical Implants·815 affected·Apr 20, 2021
High RiskFDA
Church & Dwight Co., Inc. Ogi Distribution Center
vitafusion Melatonin 140ct, 3 Pack 140 CT vitafusion Melatonin 44ct , 3Pack 44CT
Food·5,475 affected·Apr 19, 2021
High RiskFDA
Jkh Enterprises
Granny's Fudge Gorgeous Peanut Brittle, net wt. 5oz. or 8 oz, packed in a clear plastic container. No UPC. Label declares "***Ingredi...
Dairy·30 affected·Apr 19, 2021
High RiskFDA
Church & Dwight Co., Inc. Ogi Distribution Center
vitafusion Fiber Well 220ct, 10 / 220 CT
Food·2,928 affected·Apr 19, 2021
High RiskFDA
Genpak
Bake n Show¿ Muffin Tray 4 Cavity Large, Bake n Show¿ Muffin Tray 4 Cavity Large Shallow & Bake n Show¿ Muffin Tray 6 Cavity
Food·4 affected·Apr 19, 2021
High RiskFDA
Genpak
Bake n Show¿ Oven Ready Food Tray 16 ounce
Food·540 affected·Apr 19, 2021
High RiskFDA
Church & Dwight Co., Inc. Ogi Distribution Center
vitafusion SleepWell 250ct / 24 / 250 CT
Food·120 affected·Apr 19, 2021
High RiskFDA
Genpak
Bake n Show¿ Pizza Cookie Tray 12"
Bakery & Grains·55 affected·Apr 19, 2021
High RiskFDA
Church & Dwight Co., Inc. Ogi Distribution Center
vitafusion Fiber Well 90ct, 4/3 Pack 90CT
Food·7,782 affected·Apr 19, 2021
High RiskFDA
Church & Dwight Co., Inc. Ogi Distribution Center
vitafusion MultiVites 150ct,
Food·683 affected·Apr 19, 2021
High RiskFDA
Church & Dwight Co., Inc. Ogi Distribution Center
vitafusion Kids Melatonin 50ct, 4 / 3 PACK 50CT
Food·1,320 affected·Apr 19, 2021
High RiskFDA
Genpak
Bake n Show¿ Cake Tray Round & Bake n Show¿ Cake Tray Square
Bakery & Grains·55 affected·Apr 19, 2021
High RiskFDA
South Coast Baking Co.
SCB 12" Chocolate Chip Cookie Cake In CPET Tray with lid. Keep Frozen 0 Degrees F. Net Wt. 36.00 lbs. (16.33 kg) Case count: 25 Ite...
Dairy·1,096 affected·Apr 19, 2021
RecallFDA
Sigmapharm Laboratories Llc
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
Oral Drugs·6,266 affected·Apr 19, 2021
RecallFDA
Sigmapharm Laboratories Llc
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
Oral Drugs·8,786 affected·Apr 19, 2021
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM a...
Medical Devices·33 affected·Apr 19, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7...
Medical Devices·139 affected·Apr 19, 2021
High RiskFDA
Ehob, Inc.
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed ...
Medical Devices·70 affected·Apr 19, 2021