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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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9 recalls that day

Silastic Foley Catheters

Silastic Foley Catheters have a stain on their surface.

Moderate risk, FDA, Device defect

6 recalls that day

Birch Benders Sweet Potato Pancake and Waffle Mix

Birch Benders Sweet Potato Pancake and Waffle Mix may contain undeclared egg, posing a risk of serious allergic reaction.

High risk, FDA, Ended, Undeclared egg

ANI Pharmaceuticals Estradiol Gel

Estradiol Gel packets may be empty or partially full.

Moderate risk, FDA, Packaging defect

UCB Cimzia Prefilled Syringes

Cimzia prefilled syringes lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Zydus Erythromycin Tablets

Erythromycin Tablets contain N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit.

Moderate risk, FDA, Drug impurity

OneLIF Interbody Cage

The OneLIF Interbody Cage may fail to attach to its inserter, causing procedural delay or need for an alternative implant.

Moderate risk, FDA, Device defect

Medtronic Gundry and DLP Retrograde Cannulas

Medtronic retrograde cannulas may have a sterile barrier breach.

Moderate risk, FDA, Sterility problem

6 recalls that day

Llorens Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement

Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement contains black particulate matter.

Moderate risk, FDA, Ended, Foreign object

AllProvide Holistic Pet Food Gently Cooked Chicken Recipe For Dogs

AllProvide Holistic Pet Food Gently Cooked Chicken Recipe For Dogs may contain plastic.

Moderate risk, FDA, Ended, Contamination

Gas-X Simethicone Antigas Softgels

Gas-X antigas softgels have incomplete inactive ingredient information on the carton labeling.

Moderate risk, FDA, Labeling error

VitaminAlly Liquid Supplements

VitaminAlly Liquid Supplements have CGMP deviations and a possible C. botulinum (botulism) risk.

Moderate risk, FDA, Ended, Botulism

Lupin Pharmaceuticals Liraglutide Injection

Liraglutide Injection contains a white thread-like particulate matter in the cartridge.

Moderate risk, FDA, Foreign object

American National Red Cross Cryoprecipitated AHF

American National Red Cross Cryoprecipitated AHF, that failed to meet the minimum specifications for fibrinogen levels, were distributed.

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

7 recalls that day

Malazi Pure Sudanese Sesame Tahina

Malazi 100% Pure Sudanese Sesame Tahina may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

Safecor Health Atomoxetine Capsules

Atomoxetine Capsules HCL, 10 mg Capsules are mislabeled, containing 25 mg instead of 10 mg.

Moderate risk, FDA, Labeling error

American Health Packaging Primidone Tablets

Primidone Tablets are contaminated with trace amounts of Acemetacin API, which can cause cross contamination.

Low risk, FDA, Contamination

Sagent Pharmaceuticals Busulfan Injection

Sagent Pharmaceuticals Busulfan Injection may contain more impurities than allowed.

Low risk, FDA, Drug impurity

Golden State Medical Supply Primidone Tablets

Primidone Tablets are contaminated with trace amounts of Acemetacin.

Low risk, FDA, Contamination

Lannett Primidone Tablets

Primidone Tablets are contaminated with trace amounts of Acemetacin.

Low risk, FDA, Contamination

ICU Medical ChemoLock Oncology Kits and Transfer Sets

Oncology sets with extension sets may leak, causing therapy interruption and potential under-infusion.

Moderate risk, FDA, Device defect

5 recalls that day

Kroger Homestyle Cheese and Garlic Croutons

Kroger Homestyle Cheese Garlic Croutons may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

PS Seasoning & Spices Seasonings and Meat Processing Units

PS Seasoning & Spices Seasonings and Meat Processing Units may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

Dechra Veterinary Products Ophthavet Ophthalmic Solution for Dogs and Cats

Ophthavet Ophthalmic Solution may lack sterility assurance due to a potential quality concern at the manufacturing site.

Moderate risk, FDA, Sterility problem

Tangent Endoscopy Single Use Digital Catheter

The Tangent Single Use Digital Catheter can fracture at the distal shaft tip without complete detachment.

Moderate risk, FDA, Device defect

Swan-Ganz Catheter

Swan-Ganz Catheters may leak or break at the blue proximal injectate lumen hub, potentially causing infection, medication loss, or blood loss.

Moderate risk, FDA, Device defect

4 recalls that day

Straus Family Creamery Ice Cream

Organic ice cream may contain metal pieces, which can cause injury if eaten.

Moderate risk, FDA, Contamination

Prospector Popcorn Brand Belgian Chocolate Toffee Flavored Popcorn

Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn contains undeclared soy.

Moderate risk, FDA, Ended, Undeclared soy

LVIS Intraluminal Support Device

The LVIS Intraluminal Support Device may have dimensional nonconformance or incorrect configuration, potentially causing vessel injury or neurological events.

Moderate risk, FDA, Device defect

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application

The Medtronic SynchroMed Flex Infusion Mode software may display infusion steps out of order, causing the schedule not to be delivered as intended.

Moderate risk, FDA, Software defect

11 recalls that day

Sun Pharmaceutical Doxorubicin Hydrochloride Liposome Injection

DOXOrubin Hydrochloride Liposome injection contains glass particles that may cause irritation, swelling, blocked blood vessels, or life-threatening clots.

High risk, FDA, Foreign object

Hellas Meze Golden Smoked Whole Herring

Hellas Meze Golden Smoked Whole Herring may be contaminated with C. botulinum (botulism), which can cause botulism poisoning.

High risk, FDA, Botulism

IQ Produce Enoki Mushroom

Enoki Mushrooms may be contaminated with Listeria, which can cause serious infections.

High risk, FDA, Listeria

HH FRESH TRADING. Enoki Mushrooms

Imported Enoki mushrooms tested positive for Listeria, which can cause serious infections.

High risk, FDA, Listeria

Swad Mango and Orange Flavored Masala Candy

Swad Orange Flavored Masala Candy contains undeclared FD&C Yellow 6, and Swad Mango Flavored Masala Candy contains undeclared Blue 1.

Moderate risk, FDA, Ended, Undeclared color or additive

Codman CerebroFlo EVD Catheter with Endexo Technology

The product has an out-of-specification endotoxin result that did not meet acceptance criteria.

Moderate risk, FDA, Quality testing problem

Arrow Hemodialysis Catheters

Arrow Hemodialysis Catheters may not split as intended, causing withdrawal resistance, pain, bleeding, and tissue injury.

High risk, FDA, Device defect

Omnicell i.v.Station Syringe Labels

Rolls of label stock used with the Omnicell i.v.Station may cause mislabeled syringes.

High risk, FDA, Labeling error

Stryker Sustainability Solutions Reprocessed Electrophysiology Catheters

Reprocessed electrophysiology catheters have incomplete seals on sterile product.

Moderate risk, FDA, Sterility problem

Edwards EVOQUE Tricuspid Delivery System

The Edwards Evoque tricupid delivery system may have compromised functionality, which could affect the valve replacement.

Moderate risk, FDA, Labeling error

Blood Bank of Hawaii Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

6 recalls that day

Fly By Jing Creamy Sesame Noodles

Fly By Jing Creamy Sesame Noodles may contain undeclared peanut allergen, posing a risk of serious allergic reaction.

Moderate risk, FDA, Ended, Undeclared peanut

ZYMUTEST HIA IgG, in Vitro Diagnostic ELISA Kit

The Zymutest HIA IgG kit contains incorrect values for the positive control.

Moderate risk, FDA, Device defect

Philips Azurion

Philips Azurion systems have bolts and plastic parts that may loosen or break over time.

Moderate risk, FDA, Device defect

QuickVue Dipstick Strep A Test

The QuickVue Dipstick Strep A Test has the potential for false positive results.

Moderate risk, FDA, Device defect

Thermedx FluidSmart Urology Tube Set

The Thermedx FluidSmart Urology Tube Set is nonconforming due to inadvertent distribution.

Moderate risk, FDA, Device defect

Hologic Selenia Dimensions and 3Dimensions Mammography Systems

Hologic Selenia Dimensions and 3Dimensions Mammography Systems can develop loose, missing, or broken internal bolts over time.

Moderate risk, FDA, Device defect

8 recalls that day

Erotic Enhancers WAP Sensual Enhancement Capsules

WAP Sensual Enhancement Capsules contain undeclared sildenafil, tadalafil, and flibanserin, which can lower blood pressure dangerously.

High risk, FDA, Hidden drug ingredient

Pure Ground Ingredients-Organic Peppermint Leaf Powder

Pure Ground Ingredients-Organic Peppermint Leaf Powder may be contaminated with Salmonella.

High risk, FDA, Ended, Salmonella

Ascend Laboratories Metoprolol Succinate Extended-Release Tablets

Ascend Laboratories, LLC Metoprolol Succinate Extended-Release Tablets, USP, 25 mg may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Dexcom G7 CGM iOS, G7 CGM watchOS, and ONE+ iOS CGM App

Dexcom G7 CGM iOS, G7 CGM watchOS, and ONE+ iOS CGM App may perceive signal loss and deploy signal loss mitigations.

Moderate risk, FDA, Software defect