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
Kroger Co
Private Selection Chocolate Hazelnut Mascarpone Ice Cream, 16 fl oz lamented carton. Product labeled in part, "PRIVATE SELECTION" CHOCOL...
Dairy·39,588 affected·Apr 25, 2014
CriticalFDA
Kroger Co
Private Selection Caramel Hazelnut Fudge Truffle Ice Cream, 16 fl oz lamented carton. Product labeled in part, "PRIVATE SELECTION" CARAM...
Dairy·3,341 affected·Apr 25, 2014
High RiskFDA
T.h. Seafood Inc.
Raw, frozen, vacuum-packaged black cod (portions, fillets, and whole fish, various sizes).
Seafood·2,100 affected·Apr 25, 2014
RecallFDA
American Licorice Company
REDVINES FRUIT VINES Bites Cherry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Facts: ***Sodium 35g***ALLERGEN INFORMATION: CONTAIN...
Produce·455 affected·Apr 25, 2014
RecallFDA
Prestige Brands Holdings
PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed b...
Drugs·12,269 affected·Apr 25, 2014
RecallFDA
Prestige Brands Holdings
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME ...
Drugs·17,479 affected·Apr 25, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K...
Medical Devices·39 affected·Apr 25, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008...
Medical Devices·79 affected·Apr 25, 2014
High RiskFDA
Cryolife, Inc.
BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods...
Surgical Devices·6,190 affected·Apr 25, 2014
CriticalFDA
Hitachi Medical Systems America Inc
Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended...
Medical Devices·173 affected·Apr 25, 2014
RecallFDA
Siemens Medical Solutions Diagnostics
VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments an...
Medical Devices·19 affected·Apr 25, 2014
CriticalFDA
Domega Ny International Co Ltd
Brilliant Cake with Filling Milk (Biscuits), NET WT 13.9 oz (396 g), UPC 6 908166 500140, Product of China --- The product is packed in a...
Dairy·150 affected·Apr 24, 2014
High RiskFDA
Stonyfield Farm
Stonyfield YoBaby Vanilla Organic Whole Milk Yogurt multipack 6 pack plastic cups/4 oz each UPC-052159701178
Dairy·427 affected·Apr 24, 2014
High RiskFDA
Stonyfield Farm
Stonyfield YoToddler Raspberry/Pear Cereal Organic Whole Milk Yogurt with Fruit and Cereal, multipack 6 pack plastic cups/4 oz each UPC-...
Dairy·440 affected·Apr 24, 2014
High RiskFDA
Stonyfield Farm
Stonyfield YoBaby Pear/Peach Organic Whole Milk Yogurt multipack- 6 pack plastic cups- 3 peach and 3 pear/4 oz each cups UPC-052159701161
Dairy·3,429 affected·Apr 24, 2014
High RiskFDA
Actavis Laboratories, Fl, Inc.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, ...
Oral Drugs·36,538 affected·Apr 24, 2014
High RiskFDA
Baxter Healthcare Corp.
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthca...
Injectable Drugs·19,152 affected·Apr 24, 2014
High RiskFDA
Actavis Laboratories, Fl, Inc.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, ...
Oral Drugs·6,041 affected·Apr 24, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, ...
Diagnostic Devices·5 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TUMOR RES. PACK 9733553 AxiEM S.M.
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
KIT, 9731427, THORACIC TACTILE PROBES
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as ...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue defici...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
ENT PRGM 9734636 ADD FUSION NAV AxiEM
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
MOUSE 9732721 STERILE O-ARM 10PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue defi...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SPHERES 8801071 1/TRAY 12PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficienc...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the r...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
BIT 9733516 2.9mm DRILL STERILE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Baxter Healthcare Corp.
Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
Medical Devices·55 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SPHERES 8801075 5/TRAY 12PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue defici...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as...
Medical Devices·0 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
TUMOR RESECTION KIT 9733607 NON-INVASIVE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
SHUNT KIT 9733605 NON-INVASIVE
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
INSTRUMENT TRACKER 9733533XOM ENT 1PK
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Medtronic Navigation, Inc.
DISP 9730950 STRL SPHERE, 1 PK INSERT
Medical Devices·26,674 affected·Apr 24, 2014
High RiskFDA
Aqua Filter Fresh, Inc.
On cap Purified Water Bottled at Aqua Filter Fresh, Inc., Pittsburgh, PA 15239 Permit #504 Source: Plum Boro Municipal Authority 1523...
Beverages·2,436 affected·Apr 23, 2014
High RiskFDA
Kodiak Wild Alaska Seafood
Pacific Cod, skinless boneless fillet; vacuum packaged in a clear plastic bag. The wt of the fish is the only labeling included on this ...
Seafood·25 affected·Apr 23, 2014
High RiskFDA
Teva Pharmaceuticals Usa
QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminu...
Drugs·461,592 affected·Apr 23, 2014
CriticalFDA
Heraeus Kulzer, Llc.
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed...
Medical Implants·5,112 affected·Apr 23, 2014
High RiskFDA
C P Medical Inc.
Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled...
Surgical Devices·4 affected·Apr 23, 2014
High RiskFDA
William C. Domb, D.m.d., A Professional Corporation
Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per ho...
Respiratory Devices·16 affected·Apr 23, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ,...
Diagnostic Devices·2,458 affected·Apr 23, 2014