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
Atlantic Management Resources Ltd.
Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire ...
Topical Drugs·461 affected·Dec 12, 2022
High RiskFDA
Atlantic Management Resources Ltd.
Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box...
Topical Drugs·26 affected·Dec 12, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured ...
Oral Drugs·16,056 affected·Dec 12, 2022
High RiskFDA
Atlantic Management Resources Ltd.
Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box ...
Topical Drugs·51 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB81...
Respiratory Devices·40,498 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
Respiratory Devices·2,937 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. ...
Respiratory Devices·90,220 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
Respiratory Devices·4,462 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB81...
Respiratory Devices·63,278 affected·Dec 12, 2022
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas infinity central lab, Material Number 07154003001
Medical Devices·224 affected·Dec 12, 2022
High RiskFDA
Steris Corporation
VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring ...
Medical Devices·105 affected·Dec 12, 2022
High RiskFDA
Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and...
Medical Devices·857 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
Respiratory Devices·1,340 affected·Dec 12, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 e...
Medical Devices·22,156 affected·Dec 12, 2022
CriticalFDA
Byheart, Inc.
By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g
Baby Food & Formula·28,554 affected·Dec 11, 2022
High RiskFDA
Nch Life Sciences Llc
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-52...
Topical Drugs·10,930 affected·Dec 9, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Medical Devices·886 affected·Dec 9, 2022
CriticalFDA
Smiths Medical Asd Inc.
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, ...
Medical Devices·45,285,351 affected·Dec 9, 2022
CriticalFDA
Smiths Medical Asd Inc.
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Medical Devices·1,616,714 affected·Dec 9, 2022
CriticalFDA
Smiths Medical Asd Inc.
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24...
Medical Devices·47,595,495 affected·Dec 9, 2022
High RiskFDA
Mcguff Compounding Pharmacy Services, Inc.
Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Ste...
Injectable Drugs·11 affected·Dec 8, 2022
High RiskFDA
Mcguff Compounding Pharmacy Services, Inc.
Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30...
Injectable Drugs·255 affected·Dec 8, 2022
High RiskFDA
Teleflex Llc
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tub...
Medical Devices·39,690 affected·Dec 8, 2022
High RiskFDA
Detect Headquarters
Detect Covid-19 Test Product/Model Number: 21205
Medical Devices·10,142 affected·Dec 8, 2022
High RiskFDA
Teleflex Llc
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
Medical Devices·2,270 affected·Dec 8, 2022
High RiskFDA
Hartzler Family Dairy
Hartzler Family Dairy Wooster Ohio Nice List Eggnog '22 - Quart Size
Dairy·6,000 affected·Dec 7, 2022
High RiskFDA
Tri-union Frozen Products Inc
King Oscar Anchovies Flat Fillet in Olive Oil 2 oz. can 18 cans per carton UPC number: 3480060061 Ingredients: Anchovies, Olive Oil, Salt...
Seafood·263 affected·Dec 7, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limit...
Oral Drugs·23,736 affected·Dec 7, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limit...
Oral Drugs·30,612 affected·Dec 7, 2022
CriticalFDA
Philips Respironics, Inc.
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260,...
Respiratory Devices·20,807 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
Surgical Devices·0 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065
Surgical Devices·138 affected·Dec 7, 2022
High RiskFDA
The Anspach Effort, Inc.
Pediatric Craniotome Ref:CRANI-P-G1
Medical Devices·6,059 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
Surgical Devices·60 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD
Surgical Devices·0 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
Surgical Devices·1,376 affected·Dec 7, 2022
High RiskFDA
The Anspach Effort, Inc.
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
Medical Devices·6,059 affected·Dec 7, 2022
High RiskFDA
Johnson & Johnson Surgical Vision, Inc.
FUSION Dual Pump Packs, REF: OPO73
Medical Devices·7,644 affected·Dec 7, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi...
Diagnostic Devices·717 affected·Dec 7, 2022
High RiskFDA
The Anspach Effort, Inc.
7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and sh...
Medical Devices·6,059 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685
Surgical Devices·60 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827
Surgical Devices·80 affected·Dec 7, 2022
High RiskFDA
Mobius Imaging, Llc
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Medical Devices·303 affected·Dec 7, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
Surgical Devices·120 affected·Dec 7, 2022
CriticalFDA
Covidien Lp
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model ...
Surgical Devices·359,730 affected·Dec 7, 2022
High RiskFDA
The Anspach Effort, Inc.
6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping b...
Medical Devices·6,059 affected·Dec 7, 2022
High RiskFDA
Zimmer, Inc.
Identity Shoulder System Resection Planer 35mm Resection Planer
Medical Devices·84 affected·Dec 7, 2022
High RiskFDA
It'll Be Pizza, Llc.
22 oz Blonde; 20 oz Blonde EZ; 24 oz Blonde EZ frozen pizza dough manufactured by It'll Be Pizza
Frozen Food·1,678 affected·Dec 6, 2022