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
High RiskFDA
Medisca, Inc.
ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), an...
Drugs·0 affected·Apr 3, 2017
High RiskFDA
Medisca, Inc.
ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATT...
Drugs·0 affected·Apr 3, 2017
High RiskFDA
Medisca, Inc.
ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 387...
Drugs·0 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) conc...
Diagnostic Devices·12,665 affected·Apr 3, 2017
High RiskFDA
Intersurgical Inc
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pe...
Medical Devices·144 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human ser...
Diagnostic Devices·50,645 affected·Apr 3, 2017
High RiskFDA
Mederi Therapeutics, Inc
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesopha...
Surgical Devices·1,458 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high dens...
Diagnostic Devices·91,996 affected·Apr 3, 2017
High RiskFDA
Natus Medical Incorporated
Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part N...
Medical Devices·4,371 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human se...
Diagnostic Devices·128,718 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for...
Diagnostic Devices·188 affected·Apr 3, 2017
CriticalFDA
Killer Brownie Distributing Llc
ORIGINAL KB KILLER BROWNIE¿ 3x35 CT NET WT 36 LBS (16.33 kg) CONTAINS: Milk, Nuts: Pecans, Soy, Wheat UPC 10858061005031. Item #48-2016
Dairy·50 affected·Apr 1, 2017
CriticalFDA
Killer Brownie Distributing Llc
GERMAN CHOCOLATE KB KILLER BROWNIE¿ 3x35 CT NET WT 36 LBS (16.33 kg) CONTAINS: Milk, Nuts: Pecans, Soy, Wheat UPC 10858061005321. Item #4...
Dairy·33 affected·Apr 1, 2017
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Peanut Butter Killer Brownie, UPC Number 2-08185-00000. The product is sold pre-packaged by the pound in a plastic clamshell, or...
Dairy·0 affected·Apr 1, 2017
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Salted Caramel Killer Brownie with Pecans, UPC Number 2-08187-00000. The product is sold pre-packaged by the pound in a plastic ...
Bakery & Grains·0 affected·Apr 1, 2017
CriticalFDA
Killer Brownie Distributing Llc
PEANUT BUTTER KB KILLER BROWNIE¿ 3x35 CT NET WT 36 lbs (16.33 kg) CONTAINS: Milk, Nuts: Peanuts, Soy, Wheat UPC 10858061005048 . Item # ...
Dairy·30 affected·Apr 1, 2017
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Original Killer Brownies with Pecans, UPC Number 2-08184-00000. The product is sold pre-packaged by the pound in a plastic clams...
Bakery & Grains·0 affected·Apr 1, 2017
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Cookie Dough Killer Brownie, UPC Number 2-08186-00000. The product is sold pre-packaged by the pound in a plastic clamshell, or ...
Bakery & Grains·0 affected·Apr 1, 2017
CriticalFDA
Killer Brownie Distributing Llc
NOT-A-NUTTER KB KILLER BROWNIE¿ 3x35 CT NET WT 36 LBS (16.33 kg) CONTAINS: Milk, Soy, Wheat UPC 10858061005314. Item #482-2016
Dairy·42 affected·Apr 1, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Medical Devices·293,867 affected·Apr 1, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon Pro, Part No. 10270012
Medical Devices·293,867 affected·Apr 1, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon 5 Pro, Part No. 10270015
Medical Devices·293,867 affected·Apr 1, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Medical Devices·293,867 affected·Apr 1, 2017
High RiskFDA
Abbott Medical Optics Inc. (amo)
Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
Medical Devices·293,867 affected·Apr 1, 2017
CriticalFDA
Reser's Fine Foods, Inc.
Reser's Fine Foods, American Classics Macaroni Salad, Net Wt 1 lb. (454 g) UPC 7117.19007, packaged in 16 oz plastic tubs, 12 per case. R...
Produce·529 affected·Mar 31, 2017
RecallFDA
Global Commodities Inc
AAHU BARAH, DRY FIG, NET WT. 1 LB, PRODUCT OF PAKISTAN
Food·93 affected·Mar 31, 2017
High RiskFDA
Conagra Foods Inc
Premium Hunt's Chili Kit, Total NET WT 44.8 OZ (2.80 LB) 1.27kg; Directions: 1) Cook and stir meat in saucepan over medium-high 7 minut...
Meat & Poultry·5,458 affected·Mar 31, 2017
High RiskFDA
Pinnacle Foods, Llc
Great Value Bread and Butter Chips 24 Fl Oz. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716 UPC 078742145990
Dairy·3,138 affected·Mar 31, 2017
CriticalFDA
Sigma Foods Inc
Menu Del Sol Beans and Cheese Burritos, UPC 45230-05601, 8 units/case, 32oz (2lb)
Dairy·201 affected·Mar 31, 2017
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440...
Surgical Devices·15 affected·Mar 31, 2017
High RiskFDA
C.r. Bard, Inc.
Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
Medical Devices·3,450 affected·Mar 31, 2017
CriticalFDA
Oscor, Inc.
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. ...
Cardiac Devices·36,242 affected·Mar 31, 2017
High RiskFDA
Ethicon Endo-surgery Inc
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Medical Devices·792 affected·Mar 31, 2017
High RiskFDA
Supermercado Econo Inc. E
Econo, Estilo Pulpo a la Marinera, Octopus Style Marinera Sauce, Net Wt. 4oz (115g)
Food·493 affected·Mar 30, 2017
High RiskFDA
Gas Llc, Llc - Golden Alaska M/v
Pollock Fillet is frozen block, packed in waxed coated fiber block liners. Each frozen block weighs 7.45 KG. There are 3 blocks package...
Frozen Food·6,848 affected·Mar 30, 2017
High RiskFDA
Gas Llc, Llc - Golden Alaska M/v
Pollock mince is frozen block, packed in waxed coated fiber block liners. Each frozen block weighs 7.45 KG. There are 3 blocks packaged...
Frozen Food·3,330 affected·Mar 30, 2017
High RiskFDA
Supermercado Econo Inc. E
Econo, Estilo Pulpo al Ajillo, Octopus Style with Garlic Flavor, Net Wt. 4oz (115g)
Food·1,608 affected·Mar 30, 2017
High RiskFDA
Supermercado Econo Inc. E
Econo, Estilo Pulpo en Aceite, Octopus Style in Oil, Net Wt. 4oz (115g)
Food·2,400 affected·Mar 30, 2017
CriticalFDA
Ton Shen Health Inc
Life Rising Formulas SHT Chest Relief, 54 Capsules; Manufactured for: Nature's Health (USA) Chicago, IL 60616
Baby Food & Formula·37 affected·Mar 30, 2017
High RiskFDA
Bayer Healthcare Pharmaceuticals, Inc.
Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescen...
Oral Drugs·1,067,520 affected·Mar 30, 2017
High RiskFDA
Bayer Healthcare Pharmaceuticals, Inc.
Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effe...
Oral Drugs·56,064 affected·Mar 30, 2017
High RiskFDA
Bayer Healthcare Pharmaceuticals, Inc.
Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Efferve...
Oral Drugs·24,672 affected·Mar 30, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
Medical Devices·1,126 affected·Mar 30, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)
Medical Devices·6,997 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care c...
Medical Devices·2,609 affected·Mar 30, 2017
High RiskFDA
Breg Inc
Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Ca...
Medical Devices·2,609 affected·Mar 30, 2017
CriticalFDA
Thoratec Corporation
HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic...
Cardiac Devices·24,077 affected·Mar 30, 2017