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
High RiskFDA
Maui Soda & Ice Works Ltd/dba Roselani Ice Cream
Roselani Tropics Kona Mud Mud Pie Ice Cream: 1.75QT, - 56 oz. carton. Maui Soda & Ice Works, Ltd. Wailuku, HI
Dairy·2,045 affected·Jun 2, 2014
CriticalFDA
Health Matters America Inc.
ORGANIC TRADITIONS SPROUTED CHIA SEED POWDER NET WT. 8 oz. and 16 oz., UPC 854260006162, item number AHM616 and UPC 854260005462, item nu...
Food·1,818 affected·Jun 2, 2014
CriticalFDA
Health Matters America Inc.
ORGANIC SPROUTED DARK SPROUTED CHIA SEED POWDER BULK; NET WT. 50 lb; item number BLK548
Food·9,650 affected·Jun 2, 2014
High RiskFDA
Ebro North America Dba New World Pasta
Ronzoni Roasted Garlic Fettuccine Net Wt. 12 OZ. Enriched Macaroni Product shelf-stable packed in blue paperboard box all codes
Food·90,011 affected·Jun 2, 2014
CriticalFDA
Health Matters America Inc.
ORGANIC TRADITIONS ULTIMATE SUPERFOOD TRAILMIX; NET WT. 3.5 oz UPC 854260010701
Food·0 affected·Jun 2, 2014
High RiskFDA
Frito-lay, Inc
Oven Baked Lay's BBQ flavor crisps in 1 1/8 oz package, UPC 2840007189
Food·1,757,772 affected·Jun 2, 2014
CriticalFDA
Health Matters America Inc.
ORGANIC TRADITIONS CHIA SEEDS; NET WT. 8 oz., 16 oz. and 50 lb., UPC 854260006131, UPC 854260006148, no UPC for 50 lb.
Food·0 affected·Jun 2, 2014
High RiskFDA
Unit Dose Solutions Inc
Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808
Oral Drugs·1,177 affected·Jun 2, 2014
CriticalFDA
Alexion Pharmaceuticals, Inc.
Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, ...
Drugs·96,506 affected·Jun 2, 2014
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Medical Devices·907 affected·Jun 2, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc...
Diagnostic Devices·40 affected·Jun 2, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Num...
Diagnostic Devices·3,839 affected·Jun 2, 2014
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
Medical Devices·1,086 affected·Jun 2, 2014
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
Medical Devices·763 affected·Jun 2, 2014
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
Medical Devices·259 affected·Jun 2, 2014
CriticalFDA
Baptista's Bakery, Inc
Rosemary & Olive Oil Gluten Free Snack Crackers sold under the following brand names and sizes: 1. glutino, Net Wt. 4.25 oz (120g) UPC ...
Bakery & Grains·28,916 affected·May 30, 2014
CriticalFDA
Silva International, Inc.
Dehydrated minced green onion sold under the Silva brand and packaged in 28 lb. box.
Produce·166 affected·May 30, 2014
RecallFDA
Brunkow Cheese Of Wisconsin, Inc.
Brunkow Cheese of Wisconsin, Monterey Jack Morel Mushroom & Onion Cheese, 5 lb block plastic wrapped and vacuum sealed. Eight blocks per...
Dairy·18,800 affected·May 30, 2014
High RiskFDA
Caromont Farm
Chevre (Pasteurized Goats Milk Cheese) Four oz. cups Fresh Chevre / Bulk Chevre - One, two, and five pound sizes
Dairy·0 affected·May 30, 2014
High RiskFDA
Caromont Farm
Plank Road Round (Pasteurized Cows Milk Cheese).4 oz. plastic sealed with protective band.
Dairy·0 affected·May 30, 2014
High RiskFDA
Brookfield Prescription Center Inc. Dba Md Custom Rx
Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, ...
Drugs·30 affected·May 30, 2014
High RiskFDA
Brookfield Prescription Center Inc. Dba Md Custom Rx
HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Oral Drugs·850 affected·May 30, 2014
High RiskFDA
Brookfield Prescription Center Inc. Dba Md Custom Rx
HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield...
Drugs·184 affected·May 30, 2014
High RiskFDA
Brookfield Prescription Center Inc. Dba Md Custom Rx
Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Drugs·6,000 affected·May 30, 2014
High RiskFDA
Brookfield Prescription Center Inc. Dba Md Custom Rx
HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19...
Drugs·8 affected·May 30, 2014
High RiskFDA
Brookfield Prescription Center Inc. Dba Md Custom Rx
HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol D...
Drugs·55 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·15 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·65 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·122 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·71 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·83 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·2 affected·May 30, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
Diagnostic Devices·34,283 affected·May 30, 2014
High RiskFDA
Carestream Health Inc.
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently inst...
Diagnostic Devices·100 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·2 affected·May 30, 2014
High RiskFDA
Instrumed International, Inc.
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The ins...
Diagnostic Devices·156 affected·May 30, 2014
RecallFDA
The Coca-cola Company
Coca Cola Vanilla, 12 pack/12 fl oz cans, UPC: 49000 03124, Canned under authority of the Coca Cola Company, Atlanta, GA 30313 By a membe...
Food·3,606 affected·May 29, 2014
High RiskFDA
Teva Pharmaceuticals Usa
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutica...
Oral Drugs·8,472 affected·May 29, 2014
High RiskFDA
B. Braun Medical, Inc.
STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Medical Devices·10,835 affected·May 29, 2014
High RiskFDA
Mckesson Medical Immaging
Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive ...
Medical Devices·659 affected·May 29, 2014
High RiskFDA
Kerr Corporation
Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a...
Medical Devices·2,030 affected·May 29, 2014
High RiskFDA
Elekta, Inc.
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 3...
Medical Devices·224 affected·May 29, 2014
CriticalFDA
Navitas, Llc., Dba Navitas Naturals
Navitas Naturals Organic Sprouted Chia Powder, 8 oz (227g) package; Omega Fatty Acids, Protein, dietary Fiber. UPC 858847000369; Nav...
Supplements·120,275 affected·May 28, 2014
CriticalFDA
Navitas, Llc., Dba Navitas Naturals
William & Sonoma Navitas Naturals brand Omega 3 Smoothie Mixer, 8 oz. (227g) package; Dietary Fiber, Raw, Sprouted.
Beverages·19,354 affected·May 28, 2014
CriticalFDA
Navitas, Llc., Dba Navitas Naturals
Navitas Naturals Omega Blend Sprouted Smoothie Mix, 8 oz. (227g) package; Dietary Fiber, Raw, Sprouted. UPC 858847000314; Also packag...
Beverages·25,663 affected·May 28, 2014
RecallFDA
Novartis Pharmaceuticals Corp.
Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Do...
Oral Drugs·67 affected·May 28, 2014
CriticalFDA
Central Admixture Pharmacy Services, Inc.
del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Drugs·31 affected·May 28, 2014
CriticalFDA
Central Admixture Pharmacy Services, Inc.
adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Drugs·5 affected·May 28, 2014