Skip to main content

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).
Filters · 1Sort Newest
Agency
Risk level
Status
Date
Sold in

10 recalls that day

Johnson & Johnson HEALON EndoCoat PRO and HEALON DUET PRO II

Viscoelastic products used in cataract procedures may cause corneal abrasion, iris trauma, or descemet's membrane detachment if forced.

Moderate risk, FDA, Device defect

New York Blood Center Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated had a platelet count higher than acceptable.

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

New York Blood Center Apheresis Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated may have been manufactured with an incorrect ratio of blood to anticoagulant.

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

Medline Convenience Kits

Medline Convenience Kits contain applicators with a potential breach of sterility, exposing patients and users to microbial contamination.

Moderate risk, FDA, Sterility problem, FDA event number 99334

17 recalls that day

Martina Brand Fresh Whole Mangoes

Fresh whole mangoes may be contaminated with Salmonella, which can cause serious infections.

Moderate risk, FDA, Ended, Salmonella

Northwest Naturals Raw Diet for Cats and Dogs

Northwest Naturals Chicken Recipe Raw Diet for Cats and Topper for Dogs may be contaminated with Salmonella.

High risk, FDA, Salmonella

GSMS Prasugrel HCI Tablets

Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

A Place for Paws Beef Lung Treats For Dogs

Beef Lung Treats For Dogs may be contaminated with Salmonella.

High risk, FDA, Ended, Salmonella

Revcovi (Elapegademase-Lvlr) Injection

The product failed stability specifications for its protein concentration profile.

Low risk, FDA, Quality testing problem

Mylan Prasugrel Tablets

Mylan Prasugrel Tablets, USP, 10mg may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

The One SPF 50 Invisible Sunscreen Gel

The One SPF 50 Invisible Sunscreen Gel may not reliably provide the SPF 50 protection stated on the label.

Moderate risk, FDA, Wrong drug strength

Savor Seasonings Organic Cheddar Type Seasoning

Organic Cheddar Type Seasoning tested positive for undeclared milk allergen.

High risk, FDA, Undeclared milk

Weis Fresh From the Orchard Apple Cider

Weis Pasteurized Apple Cider has high patulin levels.

Moderate risk, FDA, Chemical contamination

Ron's Home Style Pico de Gallo and Salsa Autentica

Pico de Gallo and Salsa Autentica may be contaminated with Salmonella.

High risk, FDA, Ended, Salmonella

Bionpharma Doxylamine Succinate and Pyridoxine HCl Delayed-Release Tablets 10 mg/10 mg

Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets may contain foreign tablets or capsules.

Low risk, FDA, Foreign object

STA Staclot Protein S

STA Staclot Protein S may show a positive drift in QC values within its stated 4-hour onboard stability period.

Moderate risk, FDA, Device defect

Baxter Vancomycin, Insulin, Daptomycin and Other Injections

Baxter Vancomycin, Insulin, Daptomycin and Other Injections have CGMP Deviations.

Moderate risk, FDA, Manufacturing problem

Halyard Medical Convenience Kits

Halyard medical convenience kits may contain neurological sponges with unexpected variability of endotoxin levels.

Moderate risk, FDA, Sterility problem

American National Red Cross Blood Services Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were not tested for pH and were distributed.

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

Vitalant 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

American National Red Cross Red Blood Cells, Leukocytes Reduced, Irradiated

Red Blood Cells, Leukocytes Reduced, Irradiated may have been prepared incorrectly.

Moderate risk, FDA, Ended, Hospital use

6 recalls that day

B. Braun 0.9% Sodium Chloride Injection

0.9% Sodium Chloride Injection contains particulate matter that can cause life-threatening health consequences.

High risk, FDA, Foreign object

Apotex Paxil CR, Paroxetine, Extended-Release Tablets

Paxil CR, Paroxetine, Extended-Release Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Mehadrin Chocolate Leben

Mehadrin Chocolate Leben may have been improperly pasteurized.

Moderate risk, FDA, Ended, Processing problem

Hodo Chili Crisp Lightly Fried Tofu

Hodo Chili Crisp Lightly Fried Tofu may be contaminated with ink.

Not yet rated, FDA, Chemical contamination

Horizon Organic Chocolate Milk

The Horizon Organic ORG Asep Choc Milk 1% has the potential to be spoiled.

Moderate risk, FDA, Quality problem

GE Portrait Core Services Software

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer.

Moderate risk, FDA, Software defect

15 recalls that day

Revival Animal Health Feline Milk Replacers

Feline milk replacer may contain low levels of certain nutrients, which can cause health problems in kittens.

High risk, FDA, Ended, Wrong nutrient levels

Exelan Pharmaceuticals Ramipril Capsules USP

Ramipril Capsules USP, 10 mg may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

ICU Medical IV Sets with Drip Chambers

IV Sets with drip chambers may have black specks which could result in a delay in therapy.

Moderate risk, FDA, Device defect

Africando Foods Alfredo Hot Sauce

Alfredo Hot Sauce has labeling that does not list wheat and soybean oil in the ingredients.

Moderate risk, FDA, Labeling error

Byron White Formulas Herbal Supplements

Byron White Formulas Herbal Supplements have a label that does not declare walnuts in English.

Moderate risk, FDA, Undeclared tree nut

Olympus POWERSEAL Curved Jaw Sealer & Divider

The outer shelf box is incorrectly labeled as a 37-cm device.

Moderate risk, FDA, Labeling error

Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus

Zicam Cold Remedy Medicated Nasal Swabs have out-of-limit results for microbiological testing.

Moderate risk, FDA, Manufacturing problem

IMRIS Operating Room Tables ORT200 and ORT300

The operating room table may fail to lock, posing a risk of injury to the patient.

Moderate risk, FDA, Device defect

Acthar Gel (Repository Corticotropin Injection)

Acthar Gel contains particulate matter: glass and stopper piece.

Moderate risk, FDA, Foreign object

Lupin Clobetasol Propionate Cream

Clobetasol Propionate Cream failed content uniformity specifications.

Moderate risk, FDA, Quality testing problem

Healthmark ProChek Protein Tests

Healthmark ProChek-II and ProChek-W protein tests were made with an expired ingredient, which may cause false results.

Moderate risk, FDA, Device defect

FUJIFILM Synapse PACS Software

The software may cause the ruler measurement to be inaccurate.

Moderate risk, FDA, Software defect

Medline Convenience Kits

Medline convenience kits contain a potentially contaminated component.

Moderate risk, FDA, Contamination, FDA event number 99507

CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver

The suture anchor may contain an incorrect patient implant card, which may result in incorrect device identification and traceability.

Moderate risk, FDA, Device defect

Fresenius Medical Care 2008T BlueStar Hemodialysis Machine

Complaints were received about flow, no water and temperature alarms on 2008T BlueStar Hemodialysis machines.

Moderate risk, FDA, Device defect

8 recalls that day

Baxter Dextrose Injection

Dextrose Injection, USP, 70 % may contain stainless steel particles, which can cause serious health problems.

High risk, FDA, Foreign object

Baxter 0.9% Sodium Chloride Injection

0.9% Sodium Chloride Injection contains fiberglass particulate matter that may cause serious health consequences.

High risk, FDA, Foreign object

Jaime's Foods ATX Jalapeno Ranch

Jalapeno Ranch contains undeclared eggs, posing a risk of serious allergic reaction for people with egg allergies.

High risk, FDA, Undeclared egg

Baxter Anticoagulant Sodium Citrate Solution

Anticoagulant Sodium Citrate Solution may contain fiberglass particles that can cause adverse health consequences.

High risk, FDA, Hospital use, Foreign object

Safecor Health Ibuprofen Oral Suspension

Ibuprofen oral suspension may be cross-contaminated with other products.

High risk, FDA, Contamination

Henry Schein Structur 2 SC and Grandio Restorative Materials

Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

Moderate risk, FDA, Device defect

Midmark Digital ECG HD+12 and IQecg Digital ECG

A communication problem may cause incorrect electrocardiogram waveforms and an inaccurate beats-per-minute calculation.

Moderate risk, FDA, Device defect

Canon Alphenix Angiography Systems

The Alphenix X-ray system has ceiling movement gear screws that may become loose.

Moderate risk, FDA, Device defect