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
RecallFDA
Lupin Pharmaceuticals Inc.
Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg)...
Oral Drugs·4,113 affected·Nov 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Edge Plus-Computed tomography system Model 1026700
Medical Devices·80 affected·Nov 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS-Computed tomography system Model 8098027
Medical Devices·794 affected·Nov 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge -Computed tomography system Model 10590000
Medical Devices·0 affected·Nov 19, 2021
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Medical Devices·4 affected·Nov 19, 2021
High RiskFDA
Philips North America Llc
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applic...
Diagnostic Devices·5 affected·Nov 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Confidence -Computed tomography systems Model 10590100
Medical Devices·108 affected·Nov 19, 2021
CriticalFDA
Cargill Cocoa & Chocolate, Inc.
Wilbur Dark Chocolate Triple Covered Malted Milk Balls, 1-pound (lb.) bags, clear plastic bags lot #211007 MB and 210917 MB , Item Code ...
Dairy·469 affected·Nov 18, 2021
RecallFDA
Gerber Products Company Dba Nestle Infant Nutrition
GERBER Macaroni and Cheese with a side of peas and carrots, 6.6 oz. (187 g) drained weight 5.3 oz. (150 g), 8 units per case.
Dairy·4,278 affected·Nov 18, 2021
High RiskFDA
Spice House
The Spice House Sichuan Chile BBQ Rub 2.7oz glass jar UPC 816328028240
Food·737 affected·Nov 18, 2021
High RiskFDA
Motts Llp
Motts No Sugar Added Apple Sauce - 3.9 oz.
Food·528 affected·Nov 17, 2021
CriticalFDA
J F C International Inc
WEL-PAC Brand Shrimp Dashi No Moto - Powdered Shrimp Stock; Net Wt. 1.75 oz. (0.35.oz x 5 bags) 49.6 g UPC: 0 11152 83660 7 Prod...
Seafood·38 affected·Nov 17, 2021
High RiskFDA
Asp Cares
Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock R...
Injectable Drugs·3,077 affected·Nov 17, 2021
High RiskFDA
Asp Cares
Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd S...
Injectable Drugs·1,605 affected·Nov 17, 2021
CriticalFDA
Blistex Inc
Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 o...
Inhaled / Nasal Drugs·243,386 affected·Nov 17, 2021
CriticalFDA
Sandoz Inc
Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0...
Injectable Drugs·45,036 affected·Nov 17, 2021
High RiskFDA
Asp Cares
Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd St...
Injectable Drugs·896 affected·Nov 17, 2021
High RiskFDA
Medshape, Inc.
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Medical Devices·26 affected·Nov 17, 2021
High RiskFDA
Stanley Security Solutions Inc
Senior Living Arial Emergency and Nurse Call Systems
Medical Devices·11 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Medical Devices·680 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery....
Medical Devices·1,170 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK...
Medical Devices·920 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
Medical Devices·120 affected·Nov 17, 2021
CriticalFDA
Mountain Meadow Herbs, Inc.
Mountain Meadow Herbs Brand Candida Flush Endotoxin Cleans3, 500 mg per capsule, 240 capsules per bottle. UPC 8 13086 01593 2. This pro...
Food·54 affected·Nov 16, 2021
CriticalFDA
Five Star Gourmet Foods, Inc.
Simply Fresh Salads - Cranberry Walnut Salad with Very Berry Vinaigrette; sweet-tart cranberries & Walnuts, feta cheese, crunchy flatbrea...
Dairy·3,810 affected·Nov 16, 2021
High RiskFDA
Abbott
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Medical Devices·10 affected·Nov 16, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Respiratory Devices·14 affected·Nov 16, 2021
High RiskFDA
Ohio Medical Corporation
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac ...
Medical Devices·649 affected·Nov 16, 2021
CriticalFDA
The Fillo Factory Inc.
TaDah! FALAFEL STREET WRAP WITH SPICY BROWN SUGAR HARISSA HUMMUS NET WT. 7.5 OZ. UPC Code:8-5019800307-5
Food·2,800 affected·Nov 15, 2021
High RiskFDA
King's Hawaiian Bakery
Kings Hawaiian Hawaiian Sweet Hamburger Buns8 buns NET WT 12.8 oz. (362.9 g) UPC 0 73435-06050 Product Number 800020
Food·336 affected·Nov 15, 2021
RecallFDA
Aurobindo Pharma Usa Inc.
Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, ...
Oral Drugs·7,296 affected·Nov 15, 2021
CriticalFDA
Datascope Corp.
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-08...
Medical Devices·44 affected·Nov 15, 2021
High RiskFDA
Sterrx, Llc
MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 129...
Injectable Drugs·880 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 7...
Injectable Drugs·1,044 affected·Nov 12, 2021
RecallFDA
Dr. Reddy's Laboratories, Inc.
12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-R...
Oral Drugs·2,496 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC...
Injectable Drugs·36,576 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 1290...
Injectable Drugs·74,508 affected·Nov 12, 2021
RecallFDA
Dr. Reddy's Laboratories, Inc.
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Conges...
Oral Drugs·2,184 affected·Nov 12, 2021
RecallFDA
Dr. Reddy's Laboratories, Inc.
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Conges...
Oral Drugs·2,352 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 1...
Injectable Drugs·10,660 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY...
Injectable Drugs·20,640 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903,...
Injectable Drugs·3,540 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903...
Injectable Drugs·127,260 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #7...
Injectable Drugs·15,660 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 7...
Injectable Drugs·40 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903,...
Injectable Drugs·24,300 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC...
Injectable Drugs·36,360 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 1290...
Injectable Drugs·121,584 affected·Nov 12, 2021