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FDA recalls

Food, drug, biologic, medical device and cosmetic recalls from the FDA, newest first. 1,957 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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16 recalls that day

Taylor Farms Chopped and Shredded Lettuce and Salad Mixes

Iceberg lettuce products may be contaminated with Cyclospora, which can cause diarrhea and other symptoms.

High risk, FDA, Contamination

Rising Cyproheptadine Hydrochloride Syrup

Cyproheptadine Hydrochloride Syrup has a precipitate, with crystals and particles floating in the bottle.

Moderate risk, FDA, Foreign object

Major Pharmaceuticals Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets, USP may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets

Amlodipine and Olmesartan Medoxomil Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Trokendi XR, Topiramate Extended-Release Capsules

Trokendi XR, topiramate extended-release capsules may not dissolve properly in the body.

Low risk, FDA, Drug dissolving problem

Vintage Roots Root Beer Syrup

Vintage Roots Root Beer Syrup contains an unapproved food additive, sassafras bark.

Moderate risk, FDA, Ended, Undeclared color or additive

Ascend Laboratories Dabigatran Etexilate Capsules

Dabigatran etexilate Capsules 110 mg and 150 mg may contain more impurities than allowed.

Low risk, FDA, Drug impurity

Bionpharma Divalproex Sodium Delayed-Release Tablets

Divalproex Sodium Delayed-Release Tablets may contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

Ferno-Washington Power F2 Powered Fastening System

The Power F2 Powered Fastening System may experience accelerated roller wear and deformation.

Moderate risk, FDA, Device defect

Hotline Fluid Warming Set

Leakage can occur in specific lots.

Moderate risk, FDA, Device defect

Paragon 28 Phantom Hindfoot TTC/TC Ball Tipped Guide Rod

The P28 Phantom Intramedullary Nail System guide rod has a breach in its sterile barrier.

Moderate risk, FDA, Sterility problem

Boston Scientific FARASTAR Ablation Generator and Cardiac Ablation Catheter

The Farastar Ablation Generator has a configuration not compatible with the Farapoint catheter.

Moderate risk, FDA, Device defect

Boston Scientific FARASTAR Ablation Generators and Cardiac Ablation Catheters

Farastar ablation generators and catheters have instructions that do not include catheter information.

Moderate risk, FDA, Labeling error

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

The platelets did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

Versiti Blood Health Apheresis Platelets, Leukocytes Reduced, Irradiated

The pH of the product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99185

1 recall that day

Tosoh ST AIA-Pack Testosterone Test

The test's low-quality control results were lower than expected, which could cause falsely elevated or low testosterone results.

Moderate risk, FDA, Device defect

7 recalls that day

BD ChloraPrep Clear

BD ChloraPrep Clear may have an open or incomplete seal on the applicator packaging.

Moderate risk, FDA, Sterility problem

Daavlin Photera Phototherapy Devices

Photera 400, Photera 600, and Photera 600 3-D phototherapy devices have incorrect UV sensor gain.

Moderate risk, FDA, Device defect

Medline Kits Containing Zimmer Biomet Mixing Bowls and Spatulas

Medline kits with Zimmer Biomet mixing bowls and spatulas have seal nonconformities that risk sterility breach.

Moderate risk, FDA, Sterility problem

Vasoview Hemopro 2 Endoscopic Vessel Harvesting System

The device was exposed to an out-of-specification sterilization dose during a gamma sterilization run.

Moderate risk, FDA, Quality testing problem

Medtronic DLP and Bio-Medicus Cannulas

Medtronic DLP One-Piece Pediatric Arterial Cannula and Medtronic Bio-Medicus Adult Cannula Kit contain loose foreign material with trace levels of blood.

Moderate risk, FDA, Foreign object

Papablic Replacement Brush Heads

Papablic Replacement Brush Heads can break.

Moderate risk, FDA, Device defect

Rio II Nasal Pillows Interface

The Rio" II Nasal Pillows Interface has a packaging and labeling discrepancy involving product size identification and associated UDI.

Moderate risk, FDA, Labeling error

7 recalls that day

Chiesi Cleviprex Clevidipine Injectable Emulsion

Cleviprex injectable emulsion lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Amy's Organic Soups Lentil Light in Sodium

The soup has potential for spoilage.

Moderate risk, FDA, Quality problem

OLA-OLA Pounded Groundnuts (Intwilo)

Pounded groundnuts contain undeclared peanuts.

Moderate risk, FDA, Undeclared peanut

Bell Pharmaceuticals Carbamide Peroxide Ear Drops

Bell Pharmaceuticals Carbamide Peroxide Ear Drops are subpotent, with low pH and significantly reduced assay.

Moderate risk, FDA, Wrong drug strength

WY Duck Sauce

WY Duck Sauce may contain metal fragments.

Moderate risk, FDA, Foreign object

Orthofix Minirail External Fixation Devices

Unilateral external fixation devices may be incorrectly labeled.

Moderate risk, FDA, Labeling error

Ruby Artichoke Hearts Quartered

Artichoke hearts quartered contain foreign material (glass).

Moderate risk, FDA, Foreign object

10 recalls that day

Khong Guan Glutinous Rice Balls with Black Sesame Filling

Khong Guan Glutinous Rice Balls with Black Sesame Filling may contain undeclared peanuts.

High risk, FDA, Undeclared peanut

Pillsbury Bread Rolls: Hard Roll Dough and Kaiser Roll Dough

Pillsbury Bread Rolls, Hard Roll Dough may contain foreign material (glass).

Moderate risk, FDA, Foreign object

Padagis Nystatin Cream

Nystatin Cream USP may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

GE Optima XR200amx, XR220amx and XR240amx Radiographic Systems

Optima XR200amx, XR220amx, and XR240amx systems may have a column safety issue that can cause the arm to drop.

Moderate risk, FDA, Device defect

Sun Pharmaceutical Fexofenadine Hydrochloride Tablets

Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine may contain more impurities than allowed.

Low risk, FDA, Drug impurity

Functional Formularies Organic Whole Foods Meal Replacement Peptide Formulas

Liquid Hope and Nourish organic meal replacement formulas contain less vitamin A than stated.

Moderate risk, FDA, Wrong drug strength

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99184

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

The platelet yield did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99183

LifeSouth Community Blood Centers Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed without being labeled as containing red blood cell antibodies.

Low risk, FDA, Ended, Hospital use, Labeling error

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99181

7 recalls that day

Boston Scientific Rapid Refill Continuous Injection System

The Rapid Refill Continuous Injection System contains a syringe that may loosen or disconnect, causing fluid leakage or separation.

Moderate risk, FDA, Device defect

ICU Medical Plum Duo Infusion and Solo Precision IV Pump

ICU Medical Plum Duo Infusion Pump and Plum Solo Precision IV Pump may deliver up to twice the programmed volume.

Moderate risk, FDA, Device defect

Oscor Abiomed Impella Introducer Kits

Introducer kits for the Impella heart pump may leak from the sidearm, under the sheath cap, and along hub score lines.

High risk, FDA, Manufacturing problem

Argon Medical Devices Cardiovascular and Biopsy Trays

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

High risk, FDA, Sterility problem

Abiomed Impella Heart Pumps and Introducer Kits

The issue is not visually detectable.

High risk, FDA, Manufacturing problem

Olympus Evacuators

Olympus Evacuators may not be consistently sterile when sterilized per instructions.

Moderate risk, FDA, Sterility problem

Intuitive Surgical da Vinci SP Instrument Arm Drape

The da Vinci SP Instrument Arm Drape may detach, exposing a section of instrument arm, which may cause procedure delay or conversion to an alternate approach.

Moderate risk, FDA, Device defect

10 recalls that day

Versius Surgical System

The Versius Surgical System has a potential cybersecurity risk because Secure Boot was not enabled at manufacturing.

Moderate risk, FDA, Software defect

Think Surgical TMINI Femur and Tibia Tracking Arrays

The knob on the TMINI Femur and Tibia Tracking Arrays may loosen, causing potential misalignment.

Moderate risk, FDA, Device defect