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
CriticalFDA
The Santa Barbara Smokehouse, Inc.
- Cambridge House River Run Royal Smoked Salmon Products are packaged in Reduced Oxygen Package (ROP). Product is priced per pound.
Seafood·250,000 affected·Jun 4, 2015
CriticalFDA
The Santa Barbara Smokehouse, Inc.
- Santa Barbara Royal Smoked Salmon 4oz. D-Cut Products are packaged in Reduced Oxygen Package (ROP). Product is priced per pound.
Seafood·250,000 affected·Jun 4, 2015
CriticalFDA
The Santa Barbara Smokehouse, Inc.
- Private Reserve Rope Hung Smoked Scottish Salmon 4oz. Products are packaged in Reduced Oxygen Package (ROP). Product is priced per ...
Seafood·250,000 affected·Jun 4, 2015
CriticalFDA
The Santa Barbara Smokehouse, Inc.
- Cambridge House Balmoral Smoked Salmon Sliced Side - Coastal Harbor Oak Smoked Salmon Sliced Side Products are packaged in Reduced ...
Seafood·250,000 affected·Jun 4, 2015
CriticalFDA
The Santa Barbara Smokehouse, Inc.
Cambridge House Royal Smoked Salmon Sliced Side Products are packaged in Reduced Oxygen Package (ROP). Product is priced per pound.
Seafood·250,000 affected·Jun 4, 2015
High RiskFDA
Church & Dwight Inc
Gummy Vites Complete Multivitamin L'il Critters 70 gummies Manufactured for Church & Dwight Co., Inc. Ewing, NJ 08628
Supplements·3,360 affected·Jun 4, 2015
CriticalFDA
The Santa Barbara Smokehouse, Inc.
- Wild River Pacific Smoked Salmon 4oz. D-Cut Products are packaged in Reduced Oxygen Package (ROP). Product is priced per pound.
Seafood·250,000 affected·Jun 4, 2015
High RiskFDA
Fresenius Kabi Usa, Llc
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 6...
Injectable Drugs·7,593 affected·Jun 4, 2015
RecallFDA
Indiana Botanic Gardens, Inc
Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578...
Topical Drugs·630 affected·Jun 4, 2015
Medium RiskFDA
Actavis Inc
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, R...
Oral Drugs·511,283 affected·Jun 4, 2015
High RiskFDA
Panoramic Rental Corp.
Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the ...
Medical Devices·7,885 affected·Jun 4, 2015
High RiskFDA
Biomet, Inc.
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in th...
Medical Devices·75 affected·Jun 4, 2015
High RiskFDA
Gardner Denver Thomas Inc
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator
Medical Devices·508 affected·Jun 4, 2015
High RiskFDA
Biomet, Inc.
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Medical Devices·50 affected·Jun 4, 2015
High RiskFDA
Volcano Corporation
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blo...
Diagnostic Devices·162 affected·Jun 4, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same...
Medical Devices·40 affected·Jun 4, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same ...
Medical Devices·40 affected·Jun 4, 2015
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is inte...
Diagnostic Devices·1,445 affected·Jun 4, 2015
High RiskFDA
Frontiere Natural Meats
Ground Elk meat packaged individually for retail sale in hermetically sealed plastic with a black backing identified with Use or Freeze B...
Meat & Poultry·205 affected·Jun 3, 2015
High RiskFDA
Centro Naturista
Smart Lipo Dietary Supplement capsules, 950 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Supplements·0 affected·Jun 3, 2015
High RiskFDA
San Francisco Spice Company, Inc.
Eating Right Black Bean Soup; 1.3 oz paper container. Dried soup to which consumer adds hot water. USPC: 79893-80026; Ingredients: Ingre...
Meat & Poultry·13,908 affected·Jun 3, 2015
High RiskFDA
Baxter Healthcare Corp
Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare...
Injectable Drugs·145,350 affected·Jun 3, 2015
CriticalFDA
Centro Naturista
Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Oral Drugs·0 affected·Jun 3, 2015
CriticalFDA
Centro Naturista
Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Oral Drugs·0 affected·Jun 3, 2015
High RiskFDA
Biomet, Inc.
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
Medical Devices·41 affected·Jun 3, 2015
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 7412114...
Medical Implants·5,987 affected·Jun 3, 2015
High RiskFDA
Perkinelmer
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard¿" gamma counter is intended to detect and...
Medical Devices·54 affected·Jun 3, 2015
High RiskFDA
Biomet, Inc.
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
Medical Devices·53 affected·Jun 3, 2015
High RiskFDA
Omnilife Science Inc.
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a pr...
Medical Devices·146 affected·Jun 3, 2015
High RiskFDA
Perkinelmer
Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard¿" gamma counter is intended to detect and count g...
Medical Devices·179 affected·Jun 3, 2015
High RiskFDA
Perkinelmer
Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard¿" gamma counter is intended to detect an...
Medical Devices·2 affected·Jun 3, 2015
High RiskFDA
Stryker Endoscopy
SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, sh...
Medical Devices·22,063 affected·Jun 3, 2015
CriticalFDA
Elite Biomedical Solutions Llc
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from ...
Medical Devices·609 affected·Jun 3, 2015
CriticalFDA
Elite Biomedical Solutions Llc
Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from ...
Medical Devices·346 affected·Jun 3, 2015
High RiskFDA
Perkinelmer
Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter is intended to detect and count gamma...
Medical Devices·63 affected·Jun 3, 2015
High RiskFDA
The Compounding Pharmacy Of America
HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
Injectable Drugs·1,558 affected·Jun 2, 2015
High RiskFDA
The Compounding Pharmacy Of America
Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Drugs·24 affected·Jun 2, 2015
High RiskFDA
The Compounding Pharmacy Of America
HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
Injectable Drugs·55 affected·Jun 2, 2015
High RiskFDA
The Compounding Pharmacy Of America
Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Drugs·44 affected·Jun 2, 2015
High RiskFDA
The Compounding Pharmacy Of America
Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Drugs·43 affected·Jun 2, 2015
High RiskFDA
The Compounding Pharmacy Of America
Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of Ame...
Injectable Drugs·20 affected·Jun 2, 2015
High RiskFDA
The Compounding Pharmacy Of America
Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Ph...
Drugs·23 affected·Jun 2, 2015
High RiskFDA
The Compounding Pharmacy Of America
Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Fr...
Drugs·22 affected·Jun 2, 2015
High RiskFDA
The Compounding Pharmacy Of America
Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knox...
Drugs·43 affected·Jun 2, 2015
High RiskFDA
The Compounding Pharmacy Of America
Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America...
Drugs·43 affected·Jun 2, 2015
High RiskFDA
The Compounding Pharmacy Of America
Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Drugs·144 affected·Jun 2, 2015
High RiskFDA
The Compounding Pharmacy Of America
Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750 mcg/ml Intrathecal Solution, The Compounding Pharma...
Drugs·22 affected·Jun 2, 2015
High RiskFDA
The Compounding Pharmacy Of America
Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Injectable Drugs·70 affected·Jun 2, 2015