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
Sunnyside Farms
Dole Brands, Savory Spinach Dijon, 4.9 oz,
Produce·300 affected·Oct 26, 2020
RecallFDA
Jubilant Cadista Pharmaceuticals, Inc.
Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd....
Oral Drugs·23,616 affected·Oct 26, 2020
High RiskFDA
Ascent Pharmaceuticals, Inc.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, ...
Oral Drugs·9,768 affected·Oct 26, 2020
CriticalFDA
Incredible Fish
IncredibleStoneCrab, Mustard Sauce, 8 oz. plastic container, Distributed by: IncredibleStoneCrab,
Seafood·181 affected·Oct 23, 2020
CriticalFDA
Orca Bay Foods Llc
Trader Joe's brand Gluten Free Battered Halibut, SKU 00503822. Product of USA. Frozen product is packed in plastic bag and sold in retail...
Dairy·356 affected·Oct 23, 2020
RecallFDA
Heritage Pharmaceuticals Inc
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, N...
Oral Drugs·7,176 affected·Oct 23, 2020
High RiskFDA
Nostrum Laboratories Inc
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kan...
Oral Drugs·20,872 affected·Oct 23, 2020
High RiskFDA
Nostrum Laboratories Inc
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kan...
Oral Drugs·12,967 affected·Oct 23, 2020
High RiskFDA
Mako Surgical Corporation
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA ...
Medical Devices·367 affected·Oct 23, 2020
High RiskFDA
Medtronic Heart Valves Division
Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLU...
Medical Devices·71,030 affected·Oct 23, 2020
High RiskFDA
Intuitive Surgical, Inc.
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter with...
Surgical Devices·454 affected·Oct 23, 2020
High RiskFDA
Hardy Diagnostics
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic...
Medical Devices·686,920 affected·Oct 23, 2020
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidat...
Medical Implants·8,962 affected·Oct 23, 2020
High RiskFDA
Biomeme, Inc.
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplificat...
Respiratory Devices·105 affected·Oct 23, 2020
High RiskFDA
Medtronic Heart Valves Division
Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS...
Medical Devices·19,961 affected·Oct 23, 2020
High RiskFDA
Hubo International Inc
VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
Medical Devices·28,450 affected·Oct 23, 2020
CriticalFDA
Comercial Mexicana
TROPIQUE ASSORTED FRUIT JELLY BAG 30/9PCS/10.06oz and TROPIQUE JELLY ANIMAL JAR 6/26OZ
Produce·1,500 affected·Oct 22, 2020
RecallFDA
Dole Fresh Vegetables Inc
Aldi Little Salad Bar Classis Coleslaw (Green cabbage and carrots), 14 oz. plastic bag UPC:0-414498-30217-7 Kroger brand Coleslaw (G...
Produce·962 affected·Oct 22, 2020
RecallFDA
Aurobindo Pharma Usa Inc.
Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor,...
Oral Drugs·7,440 affected·Oct 22, 2020
CriticalFDA
Cook Inc.
Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless st...
Surgical Devices·61 affected·Oct 22, 2020
RecallFDA
Jmh International, Llc
Chef Myron's Szechuan Sauce, 64 FL OZ (1.89 L), Item # 400023293, 4 bottles/case
Food·719 affected·Oct 21, 2020
RecallFDA
Jmh International, Llc
Chef Myron's Tangy Teriyaki Sauce, 64 FL OZ (1.89 L), Item # 400023221, 4 bottles/case
Food·360 affected·Oct 21, 2020
RecallFDA
Jmh International, Llc
Chef Myron's Premium Teriyaki Sauce, 64 FL OZ (1.89 L), Item # 400023118, 4 bottles/case
Food·4,397 affected·Oct 21, 2020
RecallFDA
Jmh International, Llc
Chef Myron's Yakitori Sauce, 64 FL OZ (1.89 L), Item # 400023316, 4 bottles/case
Food·211 affected·Oct 21, 2020
RecallFDA
Jmh International, Llc
Chef Myron's Premium Shoyu Sauce, 1 GAL (3.78 L), Item # 400023077, 2 bottles/case; 5 GAL (18.92 L), Item # 400023279, plastic pail
Food·2,786 affected·Oct 21, 2020
RecallFDA
Jmh International, Llc
Chef Myron's Ponzu Sauce, 64 FL OZ (1.89 L), Item # 400023110, 4 bottles/case
Food·2,095 affected·Oct 21, 2020
RecallFDA
Jmh International, Llc
Chef Myron's Eurasian Fusion Sauce, 64 FL OZ (1.89 L), Item # 400023288, 4 bottles/case.
Food·52 affected·Oct 21, 2020
High RiskFDA
H & H Remedies, Llc
Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 Sou...
Topical Drugs·252 affected·Oct 21, 2020
High RiskFDA
H & H Remedies, Llc
White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadw...
Drugs·365 affected·Oct 21, 2020
High RiskFDA
H & H Remedies, Llc
Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and f) 32 oz. jars. Mfg & Sold by: H & H Remedies, LL...
Drugs·939 affected·Oct 21, 2020
CriticalFDA
Viewray, Inc.
ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in ...
Medical Devices·3 affected·Oct 20, 2020
CriticalFDA
Viewray, Inc.
ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Inp...
Medical Devices·35 affected·Oct 20, 2020
High RiskFDA
Coltene Whaledent Inc
CEI Cutting Edge Instruments (PTC-57C)
Medical Devices·556 affected·Oct 20, 2020
High RiskFDA
Coltene Whaledent Inc
FG 57 100057X (100057X)
Medical Devices·556 affected·Oct 20, 2020
High RiskFDA
Coltene Whaledent Inc
Alpen Clinic 100 Carbide Instruments (R100057C)
Medical Devices·556 affected·Oct 20, 2020
High RiskFDA
Coltene Whaledent Inc
Clinic Pack 100 Pieces FG 57 100057C (100057C)
Medical Devices·556 affected·Oct 20, 2020
RecallFDA
Denali Ingredients Llc
Denali Ingredients Supreme1251Coffee Cream Stabilizer, Item 501251-1014, 50 lb. bag. Storage: For maximum Performance Store at Ambient...
Dairy·3,050 affected·Oct 19, 2020
RecallFDA
Denali Ingredients Llc
Denali Ingredients Cream Tech 250 Sour Cream Stabilizer, Item 500120-1014, 50 lb. bag. Storage: For maximum Freshness Store at Ambient...
Dairy·2,250 affected·Oct 19, 2020
High RiskFDA
Geistlich Pharma North America, Inc.
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology...
Medical Implants·537 affected·Oct 19, 2020
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients ...
Medical Devices·8 affected·Oct 19, 2020
High RiskFDA
Starwest Botanicals, Inc
Elderberry Whole Organic; Sambucus Nigra; Origin: Croatia 1 lb. and 4 oz. Distributed in Mylar bags. 1 lb. UPC: 7 67963 07315 0; It...
Beverages·10,037 affected·Oct 16, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time...
Medical Devices·1,297 affected·Oct 16, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis ...
Diagnostic Devices·46 affected·Oct 16, 2020
CriticalFDA
Covidien Llc
Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who...
Respiratory Devices·23,329 affected·Oct 16, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal ...
Medical Devices·2,691 affected·Oct 16, 2020
High RiskFDA
Avanos Medical, Inc.
CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
Medical Devices·710 affected·Oct 16, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultras...
Medical Devices·27 affected·Oct 16, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video Syst...
Medical Devices·31 affected·Oct 16, 2020