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
CriticalFDA
Markpol Distributors Inc.
Kupiec Rice Cakes with Dark Chocolate, 3.1 oz (90g), 6 cakes packaged in white foil with a photo image of the rice cake on the front of t...
Bakery & Grains·235 affected·Oct 1, 2014
High RiskFDA
Heather's Choice
Salmon Chowder, sold under brand Heather's Choice. The product is labeled in parts: "***Salmon Chowder***HEATHER'S CHOICE***meals for...
Dairy·13 affected·Oct 1, 2014
High RiskFDA
Heather's Choice
Rancheros, sold under brand Heather's Choice. The product is labeled in parts: "***Rancheros***HEATHER'S CHOICE***meals for adventuri...
Beverages·12 affected·Oct 1, 2014
High RiskFDA
Hospira Inc.
Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x ...
Injectable Drugs·145,600 affected·Oct 1, 2014
High RiskFDA
Avella Of Deer Valley, Inc.
HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoeni...
Injectable Drugs·197 affected·Oct 1, 2014
High RiskFDA
Gilead Sciences, Inc.
Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster City, CA NDC 61...
Oral Drugs·6,290 affected·Oct 1, 2014
RecallFDA
Zydus Pharmaceuticals Usa Inc
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distrib...
Oral Drugs·15,144 affected·Oct 1, 2014
CriticalFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Respiratory Devices·324 affected·Oct 1, 2014
CriticalFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to pr...
Respiratory Devices·324 affected·Oct 1, 2014
High RiskFDA
Zimmer Dental Inc
Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X...
Medical Implants·1,044 affected·Oct 1, 2014
High RiskFDA
Medartis, Inc.
APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular...
Medical Devices·44 affected·Oct 1, 2014
High RiskFDA
Ikea North America Srvcs Inc
Elk shaped pasta Ekologiska PASTA-ALGAR FULLKORN Pasta elks wholemeal, organic NET WT 17.6 OZ (500 g) IKEA PRODUCED IN GERMANY FO...
Produce·22,025 affected·Sep 30, 2014
RecallFDA
Gilead Sciences, Inc.
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Scien...
Oral Drugs·10,317 affected·Sep 30, 2014
RecallFDA
Coopersurgical, Inc.
CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex si...
Surgical Devices·6 affected·Sep 30, 2014
High RiskFDA
Masimo Corporation
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of ...
Respiratory Devices·21,754 affected·Sep 30, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry...
Diabetes Devices·53 affected·Sep 30, 2014
RecallFDA
Coopersurgical, Inc.
CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silic...
Surgical Devices·17 affected·Sep 30, 2014
High RiskFDA
Boston Scientific Corporation
StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455
Medical Devices·7 affected·Sep 30, 2014
High RiskFDA
Oro Candy Distributors
***Oro Candy*** Vanilla Cookies (Mantecaditos) Nt. Wt. 3 oz. (85 g)
Bakery & Grains·11 affected·Sep 29, 2014
High RiskFDA
Baxter Healthcare Corp.
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
Drugs·11,808 affected·Sep 29, 2014
High RiskFDA
4-web Inc.
ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-L...
Medical Implants·35 affected·Sep 29, 2014
High RiskFDA
Coloplast Manufacturing Us, Llc
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Medical Devices·217,540 affected·Sep 29, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgica...
Surgical Devices·6,358 affected·Sep 29, 2014
High RiskFDA
Smiths Medical Asd, Inc.
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication ...
Medical Devices·24 affected·Sep 29, 2014
High RiskFDA
Dharma Research, Inc.
Dharma Cavity Varnish 15mL
Medical Devices·916 affected·Sep 29, 2014
High RiskFDA
General Mills, Inc.
Cases of refrigerated Pillsbury Biscuits Buttermilk 4pk. (6 - 4pk / case)
Dairy·720 affected·Sep 26, 2014
CriticalFDA
Anova Food, Llc
Wild Caught Seared Ahi Tuna Seasoned with Cracked Black Pepper and Garlic, manufactured by Lagniappe Louisiana Foods, Inc.-Instructions s...
Seafood·6,475 affected·Sep 26, 2014
CriticalFDA
Whole Food Market
Whole Foods Market Plain Streusel Coffeecake (no nuts), 20 oz.. packaged in a clear plastic dome/black plastic base
Bakery & Grains·14 affected·Sep 26, 2014
High RiskFDA
General Mills, Inc.
Pillsbury refrigerated Biscuit Flaky Layers retail 4pk package.
Food·720 affected·Sep 26, 2014
High RiskFDA
Tropical Valley Foods, Inc.
next by Nature brand DARK CHOCOLATE CHERRIES, NET WT. 3 Oz (85 g), UPC 817582252006 --- Produced by Tropical Valley Foods PO Box 2994 Pla...
Snacks & Candy·615 affected·Sep 26, 2014
High RiskFDA
Actavis Laboratories, Fl, Inc.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, ...
Oral Drugs·5,451 affected·Sep 26, 2014
High RiskFDA
Sun Pharma Global Inc.
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma ...
Oral Drugs·68,194 affected·Sep 26, 2014
High RiskFDA
Forest Pharmaceuticals Inc
Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Fore...
Oral Drugs·94,584 affected·Sep 26, 2014
High RiskFDA
Amerx Health Care Corp.
Amerigel Saturated Gauze Dressing Wound management
Medical Devices·21,108 affected·Sep 26, 2014
High RiskFDA
Amerx Health Care Corp.
Amerigel Post-op Surgical Kits Wound management
Surgical Devices·79,677 affected·Sep 26, 2014
High RiskFDA
Teleflex Medical
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handl...
Surgical Devices·6,197 affected·Sep 26, 2014
High RiskFDA
Biomet, Inc.
Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The...
Medical Devices·12 affected·Sep 26, 2014
High RiskFDA
Tecan Us, Inc.
Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It ...
Medical Devices·2 affected·Sep 26, 2014
High RiskFDA
Iba Dosimetry Gmbh
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Medical Devices·124 affected·Sep 25, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is mean...
Diabetes Devices·8,116 affected·Sep 25, 2014
High RiskFDA
Original Soup Man
THE ORIGINAL SOUPMAN Lobster Bisque, Net Wt 17 oz (482 g). Product is packed as a tetra pak and ships as a pack of 12 or 6 containers pe...
Seafood·3,083 affected·Sep 24, 2014
High RiskFDA
Formulations For Life
FORMULATIONS FOR LIFE Resevera Action High Potency Longevity Complex DIETARY SUPPLEMENT, 60 VEGETARIAN CAPSULES. Distributed by: Formula...
Baby Food & Formula·24 affected·Sep 24, 2014
CriticalFDA
Gold Star Smoked Fish Corp.
GOLD STAR'S FINEST COLD SMOKED STEELHEAD, Net Wt. (To Be Weighed At Time of Sale). UPC 021 143140026. Product is sold in a Vacuum Pack ...
Food·92 affected·Sep 24, 2014
High RiskFDA
Formulations For Life
FORMULATIONS FOR LIFE Vision Assure Extra Strength Vision Formula DIETARY SUPPLEMENT, 1) 60 VEGETARIAN CAPSULES, 2) 120 VEGETARIAN CAPSUL...
Baby Food & Formula·64 affected·Sep 24, 2014
CriticalFDA
Whole Herb Company
Nettle Leaf powder Gross Wt: 55.5 Lbs. Net Wt: 55.0 Lbs. This material is being sold for further processing, and for Manufacturing use...
Food·660 affected·Sep 24, 2014
High RiskFDA
Formulations For Life
Anti-Aging Naturals GENE STRENGTH Purple Longevity Dietary Supplement, 60 Vegetarian Capsules. Manufactured for Anti-Aging Naturals Vene...
Supplements·220 affected·Sep 24, 2014
RecallFDA
Zydus Pharmaceuticals Usa Inc
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by...
Oral Drugs·63,648 affected·Sep 24, 2014
High RiskFDA
Philips Medical Systems, Inc.
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva i...
Respiratory Devices·168 affected·Sep 24, 2014