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
Smith & Nephew, Inc.
RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are use...
Medical Devices·45,466 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated mon...
Medical Devices·50 affected·Jul 18, 2014
RecallFDA
X-gen Pharmaceuticals Inc.
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big F...
Injectable Drugs·8,356 affected·Jul 17, 2014
High RiskFDA
Sst Corporation
Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5
Drugs·1 affected·Jul 17, 2014
High RiskFDA
Tomotherapy Incorporated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4...
Medical Devices·322 affected·Jul 17, 2014
High RiskFDA
Genesis Bps, Llc.
Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and delive...
Medical Devices·7,272 affected·Jul 17, 2014
High RiskFDA
Pentax Medical Company
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Medical Devices·98 affected·Jul 17, 2014
CriticalFDA
Cook Inc.
CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in...
Surgical Devices·696 affected·Jul 17, 2014
High RiskFDA
Mars Food Us
Uncle Ben's(R) Ready Rice GARDEN VEGETABLE, with PEAS, CARROTS, AND CORN, NET WT. 8.8 OZ (250g), UPC 5480023334
Produce·1,964 affected·Jul 16, 2014
High RiskFDA
Bio-pharm, Inc.
Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby L...
Oral Drugs·35,739 affected·Jul 16, 2014
High RiskFDA
Tomotherapy Incorporated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1...
Medical Devices·168 affected·Jul 16, 2014
RecallFDA
Agfa Healthcare Corp.
Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B...
Diagnostic Devices·2,617 affected·Jul 16, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ EC...
Diagnostic Devices·475 affected·Jul 16, 2014
High RiskFDA
Novocol, Inc.
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during re...
Medical Devices·24 affected·Jul 16, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body flu...
Diagnostic Devices·2,757 affected·Jul 16, 2014
RecallFDA
Turkana Food Inc.
Tunas Turkish Delight Rose Flavored, Net Wt. 14.11 oz., US Importer and Distributor: Turkana Food, Inc., Exporter: Tunas Food Industry, U...
Seafood·18 affected·Jul 15, 2014
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count pat...
Topical Drugs·160,800 affected·Jul 15, 2014
High RiskFDA
Ab Sciex
AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e....
Diagnostic Devices·6 affected·Jul 15, 2014
High RiskFDA
Vascutek, Ltd.
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Medical Implants·63,162 affected·Jul 15, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VI...
Diagnostic Devices·5,906 affected·Jul 15, 2014
High RiskFDA
Coastal Kop Llc Dba King Of Pops
King of Pops Banana Puddin', frozen flavored pop cycle, Net Wt. 3.2oz., Hand Made by King of Pops, 4845 Chateau Ave., Unit D, Charleston,...
Frozen Food·100 affected·Jul 14, 2014
High RiskFDA
Florida Bottling, Inc.
Lakewood Organic Fresh Pressed GMO Free Pure Apple Cold Pressed Not from Concentrate Juice Fruit 32 FL OZ (1 QT) 946 mL Lakewood Miami, ...
Beverages·5,642 affected·Jul 14, 2014
RecallFDA
Wockhardt Usa Inc.
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; D...
Oral Drugs·840 affected·Jul 14, 2014
High RiskFDA
Baxter Healthcare Corp
***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter...
Medical Devices·234,196 affected·Jul 14, 2014
High RiskFDA
Baxter Healthcare Corp
***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Lu...
Medical Devices·11,184 affected·Jul 14, 2014
High RiskFDA
Daiichi Sankyo Pharma Development
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC...
Oral Drugs·68 affected·Jul 12, 2014
High RiskFDA
Daiichi Sankyo Pharma Development
Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo...
Oral Drugs·86 affected·Jul 12, 2014
High RiskFDA
Daiichi Sankyo Pharma Development
Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sanky...
Oral Drugs·108 affected·Jul 12, 2014
High RiskFDA
Daiichi Sankyo Pharma Development
Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi S...
Oral Drugs·0 affected·Jul 12, 2014
High RiskFDA
Daiichi Sankyo Pharma Development
Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: D...
Oral Drugs·0 affected·Jul 12, 2014
High RiskFDA
Daiichi Sankyo Pharma Development
Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- N...
Oral Drugs·262 affected·Jul 12, 2014
High RiskFDA
Daiichi Sankyo Pharma Development
Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- N...
Oral Drugs·0 affected·Jul 12, 2014
High RiskFDA
Daiichi Sankyo Pharma Development
Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsip...
Oral Drugs·5 affected·Jul 12, 2014
High RiskFDA
Tate's Wholesale, Llc.
Simply Enjoy Chocolate Chip Walnut Cookies, 7oz.
Bakery & Grains·60 affected·Jul 11, 2014
CriticalFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corpora...
Injectable Drugs·390,560 affected·Jul 11, 2014
CriticalFDA
Baxter Healthcare Corp.
Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfiel...
Injectable Drugs·171,672 affected·Jul 11, 2014
CriticalFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIA...
Injectable Drugs·217,536 affected·Jul 11, 2014
High RiskFDA
Jubilant Cadista Pharmaceuticals Inc.
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista P...
Oral Drugs·9,358 affected·Jul 11, 2014
Medium RiskFDA
Sandoz Inc
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), ...
Oral Drugs·781,000 affected·Jul 11, 2014
High RiskFDA
Ortho Development Corporation
Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial beari...
Medical Devices·13 affected·Jul 11, 2014
High RiskFDA
Amerx Health Care Corp.
Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
Medical Devices·21,108 affected·Jul 11, 2014
High RiskFDA
X Spine Systems Inc
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are s...
Surgical Devices·5 affected·Jul 11, 2014
High RiskFDA
Amerx Health Care Corp.
Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
Medical Devices·1,740 affected·Jul 11, 2014
High RiskFDA
Amerx Health Care Corp.
Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
Medical Devices·382,620 affected·Jul 11, 2014
High RiskFDA
Beevers Manufacturing & Supply, Inc.
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonata...
Medical Devices·240 affected·Jul 11, 2014