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
CriticalFDA
Renaissance Food Group Llc
Trader Joe's Southwest Style Sweet Potato Saut¿ Bowl NET WT. 21.05oz (1 LB 5.5 OZ) 610g UPC 00661126 packaged in a clear plastic bowl wit...
Food·1,512 affected·Sep 20, 2020
High RiskFDA
Dianne's Fine Desserts
Devonshire Bake Shop brand Lemon Italian Cream Cake, 10 , Yellow Cake Filled With Italian Lemon Cream, 12 slices
Dairy·770 affected·Sep 19, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems de...
Diagnostic Devices·100 affected·Sep 18, 2020
High RiskFDA
Homestead Creamery, Inc.
All Natural Chocolate Pecan ice cream, 2.5 gallons, UPC:7525200120. Packaged in a plastic container
Dairy·3 affected·Sep 17, 2020
High RiskFDA
Seafarers Inc
Frozen Yellowfin Tuna Loins, Vacuum Packed, Imported and Distributed by Seafarers, Inc, 5-8 LBS, Product of Vietnam
Seafood·20 affected·Sep 17, 2020
CriticalFDA
Homestead Creamery, Inc.
Chocolate Ice Cream, 1 quart, UPC:87525200107. Packaged in paper quart container.
Dairy·203 affected·Sep 17, 2020
RecallFDA
Grato Holdings, Inc.
Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0...
Drugs·399 affected·Sep 17, 2020
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta...
Oral Drugs·19,296 affected·Sep 17, 2020
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharett...
Oral Drugs·9,816 affected·Sep 17, 2020
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Table...
Oral Drugs·20 affected·Sep 17, 2020
High RiskFDA
Getinge Group Logistics America, Llc
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it ...
Respiratory Devices·431 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
Flow Sensor Service Part, Catalog 2089610-001-S
Medical Devices·4,794 affected·Sep 17, 2020
High RiskFDA
Genicon, Inc.
A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever...
Medical Devices·8,872 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the c...
Respiratory Devices·2 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Medical Devices·37 affected·Sep 17, 2020
High RiskFDA
Quidel Corporation
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with...
Diagnostic Devices·10,537 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support t...
Respiratory Devices·88 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
Flow Sensor Service Part, Catalog 2096513-001-S
Medical Devices·2 affected·Sep 17, 2020
High RiskFDA
Calvin Scott & Company, Inc.
Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia...
Oral Drugs·0 affected·Sep 16, 2020
High RiskFDA
Calvin Scott & Company, Inc.
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, ...
Oral Drugs·0 affected·Sep 16, 2020
High RiskFDA
Perrigo Company Plc
Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Ph...
Drugs·7,775,813 affected·Sep 16, 2020
RecallFDA
Arbor Pharmaceuticals Inc.
Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer shipping carton, Rx ...
Oral Drugs·1,846 affected·Sep 16, 2020
High RiskFDA
Calvin Scott & Company, Inc.
Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia...
Oral Drugs·0 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)0088445...
Medical Devices·3,385,442 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450...
Medical Devices·159,396 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit...
Medical Devices·371,528 affected·Sep 16, 2020
High RiskFDA
Medline Industries Inc
Quick Release Gait Belt, 60
Medical Devices·13,500 affected·Sep 15, 2020
High RiskFDA
3m Company - Health Care Business
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50...
Medical Devices·10,145,050 affected·Sep 15, 2020
High RiskFDA
Becton Dickinson & Company
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are int...
Surgical Devices·12,020 affected·Sep 14, 2020
RecallFDA
Invivo Corporation
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anato...
Diagnostic Devices·12,764 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits c...
Medical Devices·80 affected·Sep 14, 2020
High RiskFDA
Becton Dickinson & Company
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, b...
Medical Devices·72 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist ...
Cardiac Devices·60 affected·Sep 14, 2020
High RiskFDA
Philips North America, Llc
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used...
Cardiac Devices·8,942 affected·Sep 14, 2020
High RiskFDA
Percussionaire Corporation
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Respiratory Devices·212 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist ...
Cardiac Devices·32 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consi...
Cardiac Devices·16 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consi...
Medical Devices·80 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist o...
Medical Devices·20 affected·Sep 14, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Medical Devices·9,907 affected·Sep 12, 2020
High RiskFDA
Genesis Partnership Company Sa
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Compan...
Topical Drugs·5,040 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywoo...
Topical Drugs·33,480 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company...
Topical Drugs·15,000 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For:...
Topical Drugs·8,600 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Kil...
Topical Drugs·5,320 affected·Sep 11, 2020
High RiskFDA
Bien-air Surgery Sa
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical e...
Medical Devices·1,120 affected·Sep 11, 2020
High RiskFDA
Skytron, Div. The Kmw Group, Inc
VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Mo...
Medical Devices·11 affected·Sep 11, 2020
High RiskFDA
Bien-air Surgery Sa
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energ...
Medical Devices·1,120 affected·Sep 11, 2020