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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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13 recalls that day

Angiodynamics AccuVu and Soft-Vu Angiographic Catheter

Soft-Vu and AccuVu Angiographic Catheters have a manufacturing defect that may prevent a guidewire from passing through the catheter hub.

Moderate risk, FDA, Manufacturing problem

11 recalls that day

Loard's Ice Cream Desserts

Loard's Ice Cream Desserts contain undeclared color additives or allergens.

Moderate risk, FDA, Undeclared milk

Windstone Medical Packaging Custom Convenience Kits with Medline Namic Angiographic Control Syringes

Custom Convenience Kits containing Medline Namic Angiographic Control Syringes with Rotating Adapter can unwind during use, causing loose or full disconnection.

High risk, FDA, Device defect

Siemens Artis Pheno Angiography Systems

ARTIS Pheno VE30A and VE40A may capture lighter and darker patient images, causing less accurate 3D reconstruction.

Moderate risk, FDA, Device defect

Skin Script Blemish Spot Treatment

The product failed stability specifications.

Moderate risk, FDA, Quality testing problem

Apotex Desmopressin Nasal Spray

Desmopressin Nasal Spray has defective bottle caps with dislodged or missing liners.

Moderate risk, FDA, Packaging defect

Booey's Dragon's Breath Sauce

Booey's Dragon's Breath sauce has an ingredients statement that does not declare fish and sesame.

Moderate risk, FDA, Ended, Undeclared sesame

Avantor Performance Materials Magnesium Chloride 6-Hydrate Crystal

Magnesium Chloride, 6-Hydrate, Crystal may be weaker than labeled.

Low risk, FDA, Wrong drug strength

Medline CENTURION Circumcision Kit

The Centurion Circumcision Kit was distributed without the required sterilization process and is not sterile.

Moderate risk, FDA, Sterility problem

Gentuity HF-OCT Imaging System

The Gentuity HF-OCT Imaging System may repeat frames during pullback, affecting length measurements.

Moderate risk, FDA, Software defect

Philips Spectral CT on Rails

Philips Spectral CT on Rails has software issues that could cause the gantry to remain at the current scan position.

Moderate risk, FDA, Software defect

Cellex Photopheresis System CELLEX Photopheresis Kit

The Cellex Photopheresis Kit has increased difficulty installing the centrifuge bowl, which may dislodge and break, causing treatment delay and blood loss.

Moderate risk, FDA, Device defect

5 recalls that day

Raw & Unfiltered Bee Well Wildflower Honey

Raw & Unfiltered Bee Well Wildflower Honey has high sugar content.

Low risk, FDA, Ended

Cytal Wound and Burn Matrices

Cytal Wound and Burn Matrices have an increased rate of out-of-specification endotoxin results.

Moderate risk, FDA, Quality testing problem

React Health PHOENIX 5L Oxygen Concentrator

The device did not meet internal quality specifications.

Moderate risk, FDA, Quality testing problem

B. Braun Hemodialysis Bloodlines

B. Braun Hemodialysis Bloodlines may accumulate small air bubbles in the arterial line.

High risk, FDA, Device defect

Clariance Elegance Anterior Cervical Plates

The Elegance cervical plates have a burr on the finished product.

Moderate risk, FDA, Device defect

4 recalls that day

International Medication Systems Epinephrine Injection

Epinephrine injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Huons Lidocaine, Bupivacaine and Sodium Chloride Injections

Huons Lidocaine, Bupivacaine and Sodium Chloride Injections lack assurance of sterility.

Moderate risk, FDA, Sterility problem

CoValence Laboratories Hydrocortisone Gels and Balm

Island Kinetics, Inc. d.b.a. CoValence Laboratories is recalling its Remedy Gel, Essential Calming Skin Gel, and Skin Rehab because of Subpotent Drug.

Low risk, FDA, Ended, Wrong drug strength

Nephron SC Albuterol Sulfate Inhalation Solution

Albuterol Sulfate Inhalation Solution has an illegible label.

Moderate risk, FDA, Labeling error

5 recalls that day

Actavis Clonidine Transdermal System

Clonidine Transdermal System, USP, is made with an unapproved raw material.

Moderate risk, FDA, Manufacturing problem

Taro Fluocinonide Cream

The cream failed viscosity specifications.

Moderate risk, FDA, Quality testing problem

Northwest Compounders Semaglutide-Glycine-Cyanocobalamin Injectable

Semaglutide-Glycine-Cyanocobalamin Injectable lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Cook Instinct Plus Endoscopic Clipping Device

The Instinct Plus Endoscopic Clipping Device may malfunction.

Moderate risk, FDA, Device defect

Morovan Gel Nail Polish Remover

Morovan Gel Nail Polish Remover contains methylene chloride and chloroform, which are prohibited in cosmetics and may be harmful to human health.

Not yet rated, FDA

9 recalls that day

Major Pharmaceuticals Memantine Hydrochloride Extended-Release Capsules

Major Pharmaceuticals Memantine Hydrochloride Extended-Release Capsules may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Owen Biosciences Benzoyl Peroxide Acne Treatments

Owen Biosciences Benzoyl Peroxide Acne Treatments contain benzene, a chemical contamination.

Moderate risk, FDA, Chemical contamination

Cipla Cinacalcet Hydrochloride Tablets

Cinacalcet Hydrochloride Tablets contain N-Nitroso Cinacalcet above the acceptable daily intake limit.

Moderate risk, FDA, Drug impurity

Xiamen Kang Zhongyuan Biotechnology Cough Drops and Throat Soothing Drops

Xiamen Kang Zhongyuan Biotechnology is recalling 15 products.

Moderate risk, FDA, Manufacturing problem

Remel Yeastone Broth

Products may report incorrect AST results during quality control.

Moderate risk, FDA, Device defect

LinkBio CORE Workstation

The LinkBio CORE Workstation may display an incorrect planning date on the start case menu screen.

Moderate risk, FDA, Device defect

Philips AneurysmFlow

Philips AneurysmFlow software may not provide reliable prognostic information for aneurysm occlusion.

Moderate risk, FDA, Device defect

Arjo Tenor Mobile Passive Patient Lift

The Arjo Tenor mobile passive patient lift has an internal component that may not meet required mechanical strength.

Moderate risk, FDA, Device defect

Beta Bionics iLet Ace Pump Kit and Dosing Decision Software

The iLet Ace Pump Kit and Dosing Decision Software can be bypassed, allowing unauthorized access and severe hypoglycemia.

Moderate risk, FDA, Device defect

3 recalls that day

GE Healthcare Omnipaque (Iohexol) Injection

Omnipaque (iohexol) Injection contains particulate matter.

Moderate risk, FDA, Foreign object

Stryker Sustainability Solution Color Cuff

The cuffs may detach from the bladder at the welding connection.

Moderate risk, FDA, Device defect

Huvepharma Amprol 25% Type A Medicated Article

Amprol 25% (amprolium) Type A medicated article is missing its lot number and expiration date on one bag.

Low risk, FDA, Labeling error

10 recalls that day

Blaine Labs Wound Care Gels and Antifungal Creams and Solutions

Blaine Labs Wound Care Gels and Antifungal Creams and Solutions have manufacturing deviations or bacterial contamination.

High risk, FDA, Contamination

Connecticut Crab Company Crab Cakes

Crab Cakes may be temperature abused, which may result in growth of C. botulinum (botulism).

Moderate risk, FDA, Ended, Botulism

ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich

The sandwich contains visible sesame but the label does not declare it.

Moderate risk, FDA, Ended, Undeclared sesame

Viatris Xanax XR Extended-Release Tablets

Xanax XR, alprazolam, extended-release tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Teva Isotretinoin Capsules

Isotretinoin Capsules 30 mg and 40 mg may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Brahms B.R.A.H.M.S PlGF Plus KRYPTOR Diagnostic Test

The B.R.A.H.M.S PlGF Plus Kryptor test may show out-of-range quality control values, which could lead to falsely elevated sFlt-1/PlGF ratio results.

Moderate risk, FDA, Device defect

Pure Palm Medjool Dates

Pure Palm Medjool Dates are mislabeled as Coconut Date Bites.

Moderate risk, FDA, Ended, Labeling error

Ayco Farms Fresh Cantaloupe

Fresh Cantaloupe may be contaminated with Salmonella.

High risk, FDA, Ended, Salmonella

Beckman Coulter MicroScan Neg Multidrug Resistant MIC 1 Panels

MicroScan Neg Multidrug Resistant MIC 1 has a manufacturing issue with in vitro multidrug resistant test.

Moderate risk, FDA, Manufacturing problem

Mei Yu Cheng Da Trading Dadi Nongfu Dried Salt Chilli Vegetables and Olive Skewers

Mei YU Cheng DA Trading skewers contain a banned sweetener, cyclamates.

Low risk, FDA, Ended, Undeclared color or additive

5 recalls that day

Fagron Compounding Services Norepinephrine and Vancomycin Injections

These injectable drugs lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Preferred Pharmaceuticals Artificial Tears Lubricant Eye Drops

Artificial Tears Lubricant Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem