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

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68,659 recalls
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hem...
Medical Devices·211,155 affected·Dec 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hem...
Medical Devices·1,460 affected·Dec 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the...
Medical Devices·7,437,480 affected·Dec 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single u...
Medical Devices·57,825 affected·Dec 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended f...
Medical Devices·25,785 affected·Dec 30, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment u...
Medical Devices·385 affected·Dec 30, 2020
CriticalFDA
Divvies Llc
"Divvies Vegan and Nut Free Vanilla Cupcakes with Vanilla Frosting ***Net. Wt. 6 oz. "
Bakery & Grains·672 affected·Dec 29, 2020
High RiskFDA
Avalanche Distributing, Llc
Valanga Gourmet brand Snickerdoodle Cookie with cinnamon sugar on the outside. Each cookie is wrapped and sold individually. Expected she...
Dairy·1,700 affected·Dec 29, 2020
High RiskFDA
Port City Bakery, Inc
AK 10 5/8" Par Baked Stuffed Crust, frozen Pizza Crust, Item 1115660, Case Count / Unit Weight, 283 Count / 21.5 oz. Keep Frozen at 0 ...
Frozen Food·562,812 affected·Dec 29, 2020
High RiskFDA
Port City Bakery, Inc
Dough Shop Par Baked Crust, frozen pizza crusts packaged in the following sizes: 1. 16" Item # DS22316, Count / Unit Weight 14 Cou...
Frozen Food·562,812 affected·Dec 29, 2020
CriticalFDA
Divvies Llc
"Divvies Vegan and Nut Free Vanilla Cupcakes with Chocolate Frosting ***Net. Wt. 6 oz.***"
Bakery & Grains·283 affected·Dec 29, 2020
High RiskFDA
Port City Bakery, Inc
Ultimo! ParBaked Raised Edge Pizza Crust packaged in the following sizes: 1. 16" Reorder # 545145, 12 - 18 oz Crusts. Net Wt 13.5 ...
Food·562,812 affected·Dec 29, 2020
CriticalFDA
Hill Pharma Inc
Pisiva Pea Protein 80% 20 kg (44 lbs) packaged in poly lined kraft paper bags.
Food·20,000 affected·Dec 28, 2020
High RiskFDA
Sunstar Americas, Inc.
Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl o...
Oral Drugs·1,021,914 affected·Dec 28, 2020
High RiskFDA
Akorn, Inc.
Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-2...
Oral Drugs·22,248 affected·Dec 28, 2020
High RiskFDA
Mar-med Co
Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be use...
Medical Devices·52,000 affected·Dec 28, 2020
High RiskFDA
Baxter Healthcare Corporation
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascula...
Medical Implants·109 affected·Dec 28, 2020
High RiskFDA
New Standard Device Inc
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5...
Medical Devices·410 affected·Dec 28, 2020
High RiskFDA
Philips Ultrasound Inc
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi ...
Diagnostic Devices·12,080 affected·Dec 24, 2020
CriticalFDA
B & I Overseas Trading Inc.
Herring in Oil with Italian Spices: Ingredients: Herring fillet pieces (fish) sunflower oil refined deodorized, edible salt, ground spic...
Seafood·400 affected·Dec 23, 2020
High RiskFDA
Shane Erickson Inc
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottles, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55...
Drugs·36,505 affected·Dec 23, 2020
High RiskFDA
Shane Erickson Inc
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Par...
Drugs·42,157 affected·Dec 23, 2020
High RiskFDA
Genus Lifesciences Inc.
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354...
Oral Drugs·1,171,550 affected·Dec 23, 2020
High RiskFDA
Shane Erickson Inc
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Pa...
Drugs·29,376 affected·Dec 23, 2020
CriticalFDA
Fresenius Kabi Usa, Llc
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials p...
Injectable Drugs·945,425 affected·Dec 23, 2020
CriticalFDA
Combat Medical Systems, Llc
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains every...
Medical Devices·954 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Diagnostic Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Biomet, Inc.
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, oste...
Medical Devices·174 affected·Dec 23, 2020
CriticalFDA
Combat Medical Systems, Llc
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set inclu...
Medical Devices·531 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Premium At Home Pro Series Insemination Kit (SKU 644042787927)
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931,...
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Draegar Medical Systems, Inc.
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult...
Medical Devices·19,802 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Tenderneeds Fertility Llc
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
Medical Devices·0 affected·Dec 23, 2020
High RiskFDA
Rich Products Corp
OUR SPECIALTY; Cake Truffles; Variety; Chocolate; Cookies 'N Creme; NO: Artificial Colors, Flavors, or High Fructose Corn Syrup; Net Wt....
Bakery & Grains·589 affected·Dec 22, 2020
CriticalFDA
Gh Foods Ca Llc
Spinach and Orzo Pasta Kit 2/5 lb. UPC: 20826766840209 Sold at Whole Foods Stores
Produce·3 affected·Dec 22, 2020
CriticalFDA
Gh Foods Ca Llc
Pesto Pasta Salad Kit 2/5 lb. Keep refrigerated UPC: 826767000000 Sold at Amazon Stores
Produce·25 affected·Dec 22, 2020
CriticalFDA
Gh Foods Ca Llc
Asian Noodle Salad Kit 2/5 lb. Keep refrigerated Amazon UPC: 826767000000; Whole Foods UPC: 20826766840025 Sold at Amazon Stores and...
Produce·87 affected·Dec 22, 2020
CriticalFDA
Gh Foods Ca Llc
Smoked Mozzarella Pasta Salad Kit 2/5 lb. UPC: 20826766840186 Sold at Whole Foods Stores
Produce·22 affected·Dec 22, 2020
High RiskFDA
Country Fresh Orlando, Llc
Party Tray Vegetables with Ranch Dip, packaged in 40 oz (2.5 LBS) plastic tray with lid, UPC 3825911509.
Produce·200 affected·Dec 22, 2020
CriticalFDA
Gh Foods Ca Llc
Italian Pasta Salad Kit 2/5 lb. UPC: 20826766811377 Sold at Whole Foods Stores
Produce·3 affected·Dec 22, 2020