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
Creative Foods Inc
Bueno Coffee Substitute Pecan Praline, Gluten-Free, net wt. 7 oz. (200g), UPC 6 79345 10010 4. INGREDIENTS: Simply Garbanzo Beans and Nat...
Beverages·1,519 affected·Apr 16, 2021
RecallFDA
Driscoll's Inc.
Driscoll's Fresh Blackberries; 6 oz. or 18 oz. containers.
Produce·109 affected·Apr 16, 2021
CriticalFDA
Creative Foods Inc
Bueno Coffee Substitute Creamy Hazelnut, Gluten-Free, net wt. 7 oz. (200g), UPC 6 79345 10020 3. INGREDIENTS: Garbanzo Beans (Chickpeas) ...
Beverages·1,341 affected·Apr 16, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 D...
Drugs·10,872 affected·Apr 16, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Flori...
Topical Drugs·12,060 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or ...
Respiratory Devices·2 affected·Apr 16, 2021
High RiskFDA
Hardy Diagnostics
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Medical Devices·69 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or lon...
Respiratory Devices·34 affected·Apr 16, 2021
High RiskFDA
Terumo Cardiovascular Systems Corporation
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for...
Medical Devices·995 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or lon...
Respiratory Devices·18 affected·Apr 16, 2021
High RiskFDA
Terumo Cardiovascular Systems Corporation
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an ext...
Medical Devices·1,176 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or ...
Respiratory Devices·12 affected·Apr 16, 2021
High RiskFDA
Luminex Corporation
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Diagnostic Devices·296 affected·Apr 16, 2021
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Medical Devices·9 affected·Apr 16, 2021
High RiskFDA
Grace Healthcare Medical, Inc
Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Ga...
Drugs·35,838 affected·Apr 15, 2021
High RiskFDA
Vygon U.s.a.
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Medical Devices·8,320 affected·Apr 15, 2021
High RiskFDA
Flower Orthopedics Corporation
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T2...
Medical Devices·47 affected·Apr 15, 2021
High RiskFDA
Boston Scientific Corporation
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposu...
Medical Devices·8,524 affected·Apr 15, 2021
High RiskFDA
Haag-streit Usa Inc
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Medical Devices·0 affected·Apr 15, 2021
High RiskFDA
Boston Scientific Corporation
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and...
Medical Devices·4,549 affected·Apr 15, 2021
High RiskFDA
Michael Zakany Llc
Jose Madrid Salsa - Strawberry Mild Salsa 13oz glass jars, 12 jars per case
Produce·6,659 affected·Apr 14, 2021
High RiskFDA
Champlain Chocolate Company
Organic Mr. Goodtime Bunny***NET WT 3.35 LBS (1.4kg)***INGREDIENTS: *Milk, *Dark, AND *WHITE CHOCOLATE (*SUGAR, *MILK POWDER, *COCOA BUTT...
Dairy·443 affected·Apr 14, 2021
High RiskFDA
Reser's Fine Foods, Inc.
Freshness Guaranteed Macaroni Salad Amish, item # 579284, refrigerated, packaged in a clear cup with clear snap on lid, net wt. 32 oz. UP...
Produce·16,614 affected·Apr 14, 2021
High RiskFDA
Champlain Chocolate Company
"Basket Country Bunny ORG" that contains the Organic Mr. Goodtime Bunyy***NET WT 3.35 LBS (1.4kg)***INGREDIENTS: *Milk, *Dark, AND *WHITE...
Dairy·443 affected·Apr 14, 2021
High RiskFDA
Shearer's Snacks
Raley's Salt & Vinegar Flavored Potato Chips 9.5oz flexible plastic packaging 11 bags per case
Snacks & Candy·420 affected·Apr 14, 2021
CriticalFDA
T Marzetti Innovation Center
Blanched Penne Rigati 8oz plastic bag 40 bags per case
Food·210 affected·Apr 14, 2021
High RiskFDA
Blount Fine Foods Corporation
Panera Lobster Bisque, 16 oz.
Seafood·17,992 affected·Apr 14, 2021
High RiskFDA
Fresenius Medical Care, North America
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60...
Drugs·709 affected·Apr 14, 2021
High RiskFDA
Beckman Coulter Inc.
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Medical Devices·1,034 affected·Apr 14, 2021
High RiskFDA
Radiometer Medical Aps
E3800 PC Units (spare parts)
Medical Devices·965 affected·Apr 14, 2021
High RiskFDA
Radiometer Medical Aps
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Medical Devices·3,346 affected·Apr 14, 2021
High RiskFDA
Torn & Glasser, Inc.
Dark Chocolate Expresso Beans; Net Wt. 12 oz. (340g), Best if used by 11-19-2021. Contains Soy, May Contain Milk. Packed in a facil...
Dairy·622 affected·Apr 13, 2021
High RiskFDA
Snak King Corporation
Trader Joe's Restaurant Style White Corn Tortilla Chips; Net Wt. 9 oz. (255g)
Snacks & Candy·8,825 affected·Apr 13, 2021
High RiskFDA
Mountain West Mothers' Milk Bank Inc.
Mountain West Mothers' Milk Bank - Pasteurized Donor Human Milk, 3 fluid ounce BPA free plastic bottles, embossed with "Donor Human Milk"...
Dairy·140 affected·Apr 13, 2021
RecallFDA
Nomax Inc
Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Ma...
Ophthalmic Drugs·78 affected·Apr 13, 2021
High RiskFDA
Philips North America Llc
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Medical Devices·2 affected·Apr 13, 2021
CriticalFDA
Nature's Sunshine Products
Love & Peas Protein Rich Meal Replacement, Sugar Free, 1 LB 9 OZ (713 G) bag, Nature's Sunshine Products, Inc., Spanish Fork, Utah, 84660...
Food·2,480 affected·Apr 12, 2021
High RiskFDA
Backcountry Mills Llc
G4G Low Carb Pancake & Waffle Mix, Keto Friendly Just Add Water Net Wt 12 ounces, 6pack Case UPC 860000241427 packaged in a rigid cardboa...
Bakery & Grains·2,016 affected·Apr 12, 2021
RecallFDA
Indiana Botanic Gardens, Inc
Botanic Choice Green Tea Leaf Extract (3:1 Extract), Alcohol Free Liquid Extract, 1 FLOZ., in glass jar with dropper, UPC 703308200164
Beverages·455 affected·Apr 12, 2021
High RiskFDA
Ample Hills Manufacturing Llc.
Ample Hills Creamery Chocolate Milk and Cookies Ice Cream, 14 oz.
Dairy·1,316 affected·Apr 12, 2021
CriticalFDA
Nature's Sunshine Products
Love & Peas Protein Rich Meal Replacement, 1 LB 8 OZ (675 G) bag, Nature's Sunshine Products, Inc., Spanish Fork, Utah, 84660 (800) 223-8...
Food·6,069 affected·Apr 12, 2021
High RiskFDA
Preferred Pharmaceuticals, Inc.
Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Pre...
Oral Drugs·0 affected·Apr 12, 2021
High RiskFDA
Edge Pharma, Llc
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMI...
Topical Drugs·5,850 affected·Apr 12, 2021
High RiskFDA
Dj Orthopedics De Mexico S.a. De C.v.
DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes...
Medical Devices·0 affected·Apr 12, 2021
CriticalFDA
Boston Scientific Corporation
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
Medical Implants·550 affected·Apr 12, 2021
High RiskFDA
Hostess Brands Llc
Hostesss SnoBalls packaged as Hostess Chocolate CupCakes, Net Wt 3.17 OZ, UPC 8 88109 01001 0, Hostess Brands, LLC Kansas City, MO
Bakery & Grains·648 affected·Apr 10, 2021
High RiskFDA
Teligent Pharma, Inc.
Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
Topical Drugs·3,432 affected·Apr 9, 2021
CriticalFDA
Avid Medical, Inc.
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Medical Devices·720 affected·Apr 9, 2021