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
Leo Leo Gelato
Strawberry Cream gelato, 5 Liter & 4 Liter pans
Dairy·1,031 affected·Oct 26, 2016
High RiskFDA
Pastian's Bakery
Home Wheat Texas Toast 1 lb. 8 oz. Clear Plastic Bag. 1 loaf
Food·62 affected·Oct 26, 2016
CriticalFDA
Stewarts Shops Corp
Stewart's SPORTADE FRUIT PUNCH Isotonic Beverage 20 Fl Oz (591 mL), UPC 0 82086 31006 8. The product is packaged in a plastic bottle, and...
Beverages·1,622 affected·Oct 26, 2016
High RiskFDA
Pastian's Bakery
1 1/2 French Bread. 1lb. 8 oz.. Clear Plastic Bag. 1 loaf
Bakery & Grains·50 affected·Oct 26, 2016
High RiskFDA
Fanega Mexican Food Products, Inc.
10" Flour Tortillas 12 count, Net Wt. 25oz (732g)
Food·280 affected·Oct 26, 2016
CriticalFDA
Leo Leo Gelato
Blackberry Cabernet gelato, 5 Liter & 4 Liter pans
Produce·1,031 affected·Oct 26, 2016
CriticalFDA
Leo Leo Gelato
Strawberry Basil gelato, 5 Liter & 4 Liter pans
Produce·1,031 affected·Oct 26, 2016
High RiskFDA
Pastian's Bakery
Pumpernickle Bread. 1 lb. 8 oz. Clear Plastic Bag. 1 loaf
Bakery & Grains·1 affected·Oct 26, 2016
CriticalFDA
Leo Leo Gelato
Strawberry White Chocolate gelato, 5 Liter & 4 Liter pans
Snacks & Candy·1,031 affected·Oct 26, 2016
High RiskFDA
Pastian's Bakery
Extra Sourdough Bread-2 Squares. 32 oz. Clear Plastic Bag. 1 loaf
Bakery & Grains·0 affected·Oct 26, 2016
High RiskFDA
Pastian's Bakery
Extra Sourdough Bread. 32 oz. Clear Plastic Bag. 1 loaf
Bakery & Grains·6 affected·Oct 26, 2016
CriticalFDA
Leo Leo Gelato
Blackberry Sorbet, 5 Liter & 4 Liter pans
Produce·1,031 affected·Oct 26, 2016
CriticalFDA
Leo Leo Gelato
Raspberry Chip gelato, 5 Liter & 4 Liter pans
Snacks & Candy·1,031 affected·Oct 26, 2016
RecallFDA
Diagnostic Hybrids, Inc.
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Diagnostic Devices·26 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavi...
Surgical Devices·2,172 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the...
Surgical Devices·5,055 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the ...
Surgical Devices·4,836 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the c...
Surgical Devices·1,617 affected·Oct 26, 2016
High RiskFDA
Chesterman Co
A&W Cream Soda, 20 FL OZ, Caffeine Free
Dairy·1,010 affected·Oct 25, 2016
High RiskFDA
Beckman Coulter Inc.
MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility ...
Medical Devices·131 affected·Oct 25, 2016
High RiskFDA
Trumpf Medical Systems, Inc.
OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 ...
Medical Devices·4 affected·Oct 25, 2016
High RiskFDA
Burel Pharmaceuticals Inc
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, ...
Oral Drugs·35,149 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate...
Oral Drugs·604 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, ...
Oral Drugs·17,788 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate ...
Oral Drugs·2,771 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methy...
Oral Drugs·2,861 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, M...
Oral Drugs·795 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylen...
Oral Drugs·823 affected·Oct 24, 2016
High RiskFDA
Burel Pharmaceuticals Inc
UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phen...
Oral Drugs·11,539 affected·Oct 24, 2016
High RiskFDA
Beckman Coulter Inc.
Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Acces...
Diagnostic Devices·357 affected·Oct 24, 2016
High RiskFDA
Domain Surgical, Inc.
FMsealer Open Shears. Model FM3001
Medical Devices·70 affected·Oct 24, 2016
High RiskFDA
Sokol And Co
Solo Almond Paste, 6/7 LB. Cans, Net Weight: 42 LBS. (19.09 KG.)
Food·486 affected·Oct 21, 2016
RecallFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts Original Glazed Doughnuts, 6 count and 12 count boxes.
Food·12 affected·Oct 21, 2016
CriticalFDA
Jml Holdings Inc
Three Way Popcorn Sampler that contains three types of popcorn (cheese, carmel and buttered popcorn) packed inside one unlabeled clear pl...
Dairy·8 affected·Oct 21, 2016
High RiskFDA
Akorn Inc
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
Ophthalmic Drugs·29,972 affected·Oct 21, 2016
CriticalFDA
Syncardia Systems Inc.
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Cardiac Devices·5 affected·Oct 21, 2016
CriticalFDA
Centurion Medical Products Corporation
Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring a...
Surgical Devices·1,000 affected·Oct 21, 2016
RecallFDA
Euro Diagnostica Ab
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) a...
Diagnostic Devices·4 affected·Oct 21, 2016
RecallFDA
Euro Diagnostica Ab
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the ...
Diagnostic Devices·6 affected·Oct 21, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
Medical Devices·23 affected·Oct 21, 2016
RecallFDA
Euro Diagnostica Ab
is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of an...
Diagnostic Devices·4 affected·Oct 21, 2016
CriticalFDA
St Clair Foods, Inc.
HEARTLAND ENTREES DUMPLINGS AND BROTH, Product Code 856140, NET WEIGHT: (320 ozs)(9.09 kg)(4-5 Lbs), KEEP FROZEN
Frozen Food·155 affected·Oct 20, 2016
High RiskFDA
Brownwood Farms
Brownwood Farms Michigan Cherry Preserves 12oz glass bottles and 1 gallon. Private labels: Art's Tavern (Cherry Preserves 12oz).
Food·115,195 affected·Oct 20, 2016
High RiskFDA
Brownwood Farms
Brownwood Farms Jalapeno Cherry Butter 12oz and 20oz glass bottles and 1 gallon. Private labels: Kimmel Orchard & Vineyard (Jalapeno C...
Dairy·17,024 affected·Oct 20, 2016
High RiskFDA
Brownwood Farms
Brownwood Farms America's Original Cherry Butter 12oz and 22oz glass bottles and 1 gallon. Private labels: Arbor Day Farm (Cherry But...
Dairy·52,510 affected·Oct 20, 2016
High RiskFDA
Brownwood Farms
Brownwood Farms Pear & Cinnamon Preserves 10oz glass bottles and 1 gallon.
Food·17,059 affected·Oct 20, 2016
RecallFDA
Cutispharma, Inc.
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 6562...
Drugs·5,904 affected·Oct 20, 2016
RecallFDA
Cutispharma, Inc.
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 6562...
Drugs·8,748 affected·Oct 20, 2016