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
Synthes (usa) Products Llc
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum followi...
Medical Devices·451 affected·Jul 22, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine s...
Diagnostic Devices·399 affected·Jul 22, 2015
High RiskFDA
Volcano Corporation
Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pio...
Surgical Devices·5,042 affected·Jul 22, 2015
High RiskFDA
Medtronic Minimed Inc.
Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the ...
Diabetes Devices·254 affected·Jul 22, 2015
High RiskFDA
Kellbran Candies And Snacks Inc
KellBran" CANDIES, INC. creamy rich caramel popcorn Net Wt. 8 oz. (226.64 Grams) ALLERGY INFO: Manufactured in a facility that processes ...
Dairy·150 affected·Jul 21, 2015
RecallFDA
Apotex Inc.
Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research P...
Oral Drugs·2,075 affected·Jul 21, 2015
High RiskFDA
Pharmedium Services, Llc
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Servic...
Drugs·120 affected·Jul 21, 2015
RecallFDA
Pd-rx Pharmaceuticals, Inc.
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (...
Oral Drugs·1,685 affected·Jul 21, 2015
High RiskFDA
Wright Medical Technology, Inc.
CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3...
Medical Devices·5,687 affected·Jul 21, 2015
High RiskFDA
Wright Medical Technology, Inc.
CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0...
Medical Devices·107 affected·Jul 21, 2015
CriticalFDA
Carefusion 303, Inc.
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226...
Medical Devices·68,460 affected·Jul 21, 2015
High RiskFDA
Neuro Kinetics, Inc.
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic...
Diagnostic Devices·45 affected·Jul 21, 2015
CriticalFDA
Conagra Foods Inc
CiCi's Cavatappi, Enriched Macaroni Product, packaged in 5-lb. bags, 4 bags per case, Packed exclusively for use by CiCi's Pizza and its ...
Food·63,015 affected·Jul 20, 2015
High RiskFDA
Raymond-hadley Corp.
Pride of Africa brand Enriched Farina, Net Weight 5 lb. (2.27 kg), UPC 016712016840 --- Product of The Raymond-Hadley Corp. Spencer, NY 1...
Food·200 affected·Jul 20, 2015
RecallFDA
Qualitest Pharmaceuticals
ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0...
Oral Drugs·21,552 affected·Jul 20, 2015
High RiskFDA
Trilliant Surgical Ltd.
Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm;...
Medical Devices·638 affected·Jul 20, 2015
High RiskFDA
Trilliant Surgical Ltd.
Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are compone...
Medical Implants·71 affected·Jul 20, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Do...
Surgical Devices·524 affected·Jul 20, 2015
High RiskFDA
Trilliant Surgical Ltd.
2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE...
Medical Implants·102 affected·Jul 20, 2015
High RiskFDA
Elcam Medical, Inc.
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elc...
Medical Devices·248,100 affected·Jul 19, 2015
High RiskFDA
Elcam Medical, Inc.
Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administrat...
Medical Devices·7,721,580 affected·Jul 19, 2015
High RiskFDA
It Takes A Village Foods, Llc
Kale Crisps Lemon Parmesan sold under brand Veggie Evolution, each plastic package has a net weight 1.5 oz. There are six packages per c...
Dairy·1,087 affected·Jul 17, 2015
High RiskFDA
It Takes A Village Foods, Llc
Vegetable Crisps Lemon Parmesan sold under brand Veggie Evolution, each poly pouch has a net weight 2 oz. There are 6 packages per case. ...
Dairy·5,913 affected·Jul 17, 2015
CriticalFDA
Barrel O' Fun Snack Foods, Inc.
Vic's All Natural Original White Popcorn, Net Wt. 1-1/8 oz (32g), UPC 46555-00062
Snacks & Candy·37 affected·Jul 17, 2015
High RiskFDA
Optimal Nutrition, Inc
FITzee Foods Paleo Turkey Meatloaf all sizes (small, medium, large and XL)
Meat & Poultry·290 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx...
Injectable Drugs·545 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Pro...
Injectable Drugs·25 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T...
Injectable Drugs·450 affected·Jul 17, 2015
CriticalFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 6001...
Injectable Drugs·189,120 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Pro...
Injectable Drugs·6,970 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6...
Injectable Drugs·25 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441, NDC 61553-441-80
Drugs·1,161 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharM...
Injectable Drugs·8,955 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium,...
Injectable Drugs·1,522 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Produ...
Injectable Drugs·2,495 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.
Drugs·1,700 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3106.
Drugs·499 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.
Injectable Drugs·16,366 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102.
Drugs·2,961 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product co...
Drugs·660 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMED...
Injectable Drugs·935 affected·Jul 17, 2015
RecallFDA
Sun Pharma Global Fze
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceu...
Oral Drugs·35,235 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Pro...
Injectable Drugs·26,079 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syr...
Injectable Drugs·21,506 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV u...
Injectable Drugs·3,270 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.
Drugs·499 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Con...
Drugs·210 affected·Jul 17, 2015
High RiskFDA
Pharmedium Services, Llc
neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550.
Injectable Drugs·250 affected·Jul 17, 2015