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
Arrow International Inc
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Acces...
Surgical Devices·2,480 affected·Feb 4, 2013
High RiskFDA
Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump ...
Medical Devices·20,311 affected·Feb 4, 2013
RecallFDA
Ultradent Products, Inc.
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC....
Medical Devices·32 affected·Feb 4, 2013
High RiskFDA
Hospira Inc.
The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood an...
Medical Devices·2,791 affected·Feb 4, 2013
RecallFDA
Ultradent Products, Inc.
Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Us...
Medical Devices·100 affected·Feb 4, 2013
High RiskFDA
Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump ...
Medical Devices·35,596 affected·Feb 4, 2013
CriticalFDA
Goldcoast Salads
GoldCoast Salads Smoked Salmon Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
Seafood·1,567 affected·Feb 1, 2013
CriticalFDA
Goldcoast Salads
GoldCoast Salads Marine Lobster Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
Seafood·6,919 affected·Feb 1, 2013
CriticalFDA
Goldcoast Salads
GoldCoast Salads Lobster & Shrimp Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
Seafood·2,284 affected·Feb 1, 2013
Medium RiskFDA
Fresenius Kabi Usa Llc (fk Usa)
CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Phar...
Injectable Drugs·155,900 affected·Feb 1, 2013
RecallFDA
Ferring Pharmaceuticals Inc
TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & Specialty Produc...
Injectable Drugs·126 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·363,892 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·21,703 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and ca...
Medical Devices·179 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used ...
Medical Devices·21,551 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·10,609 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used ...
Medical Devices·7,692 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used f...
Medical Devices·1 affected·Feb 1, 2013
High RiskFDA
Greiner Bio-one North America, Inc.
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood...
Medical Devices·192,000 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·184,399 affected·Feb 1, 2013
High RiskFDA
Hospira Inc.
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used ...
Medical Devices·214 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·7,848 affected·Feb 1, 2013
High RiskFDA
Icu
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general...
Medical Devices·7,351 affected·Feb 1, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indi...
Medical Devices·154 affected·Feb 1, 2013
High RiskFDA
L. K. Bowman, Incorporated
Canned mushrooms, #10 cans (Brites, not labeled)
Food·3,480 affected·Jan 31, 2013
RecallFDA
Lupin Pharmaceuticals Inc.
Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. ...
Oral Drugs·64,368 affected·Jan 31, 2013
CriticalFDA
Gilead Sciences, Inc.
Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA...
Injectable Drugs·3,181 affected·Jan 31, 2013
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count pat...
Topical Drugs·335,910 affected·Jan 31, 2013
High RiskFDA
Salyer Prn Biomedical
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in car...
Surgical Devices·9 affected·Jan 31, 2013
High RiskFDA
Medtronic Navigation, Inc.
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Medical Devices·463 affected·Jan 31, 2013
High RiskFDA
Hitachi Medical Systems America Inc
Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imagi...
Medical Devices·45 affected·Jan 31, 2013
High RiskFDA
R-kane Products Inc.
Z Pro 25 High Protein Supplement Net. Wt. 1.3 oz. - Vanilla Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 Natio...
Baby Food & Formula·0 affected·Jan 30, 2013
High RiskFDA
R-kane Products Inc.
Z Pro 25 High Protein Supplement Net. Wt. 1.5 oz. - Chocolate Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 Na...
Snacks & Candy·0 affected·Jan 30, 2013
High RiskFDA
Tumalo Farms Llc
A soft brie-style cheese called Jewell. Ingredients: Certified organic cows' milk, Pasteurized farmstead goats' milk, cultures, rennet ...
Dairy·222 affected·Jan 30, 2013
High RiskFDA
Tumalo Farms Llc
A soft chevre-style cheese. Label reads in part, "*** TUMALO FARMS Artisan Cheeses of Central Oregon Chevita This fresh and mild, soft, ...
Dairy·1 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceutica...
Inhaled / Nasal Drugs·355 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayrevil...
Drugs·26,315 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX...
Drugs·216,838 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC...
Inhaled / Nasal Drugs·330,158 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,0887...
Drugs·12,120 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: ...
Drugs·22,721 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, ...
Drugs·16,836 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Broo...
Drugs·348 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayrevi...
Drugs·12,988 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmace...
Inhaled / Nasal Drugs·1,398 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: A...
Inhaled / Nasal Drugs·348 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS ...
Oral Drugs·242,470 affected·Jan 30, 2013
High RiskFDA
Tg United, Inc.
Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Qui...
Oral Drugs·977,719 affected·Jan 30, 2013