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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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2 recalls that day

Nara Organics Whole Milk Organic Infant Formula

Nara Organics Whole Milk Organic Infant Formula may be contaminated with C. botulinum (botulism), which can cause infant botulism.

High risk, FDA, Botulism

Arrow International Vascular Access and Catheterization Kits

Arrow International Vascular Access and Catheterization Kits contain lidocaine, bupivacaine.

High risk, FDA, Sterility problem

9 recalls that day

Fry Pie Factory Pepperoni Rolls

Pepperoni Rolls contain undeclared milk and were not refrigerated, posing risks of allergic reaction and food-borne illness.

Moderate risk, FDA, Ended, Undeclared milk

Dabur Antifungal, Antibiotic and Hydrocortisone Creams and Ointments

Antifungal athlete's foot cream and other ointments and creams have manufacturing problems.

Moderate risk, FDA, Manufacturing problem

Inventia Healthcare Chlorthalidone Tablets

Chlorthalidone Tablets, USP, 25 mg may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Sandoz Focalin XR Extended-Release Capsules

Sandoz is recalling its Focalin XR (dexmethylphenidate HCl) because of labeling: Incorrect or Missing Lot and/or Exp Date.

Low risk, FDA, Labeling error

Glenmark Alyacen 7/7/7 and Norethindrone and Ethinyl Estradiol Tablets

Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

IntegraDose Compounding Services Vasopressin Syringes

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

VistaPharm Kerr Insta-Char Activated Charcoal

Kerr Insta-Char in aqueous or sorbitol base with cherry flavor does not meet the OTC Monograph.

Moderate risk, FDA, Quality testing problem

Medline Convenience Kits

The butyrate tubing may crack during actuation and render the product unusable for application.

Moderate risk, FDA, Device defect

Automated Impella Controller (AIC)

The Automated Impella Controller has a potential software error when used with left ventricular Impella devices.

High risk, FDA, Software defect

11 recalls that day

Azuma Foods TAKO WASABI Seasoned Octopus with Wasabi

Seasoned octopus with wasabi may contain undeclared fish, posing a risk of serious allergic reaction.

High risk, FDA, Undeclared fish

Golden State Medical Supply Niacin Extended-Release Tablets

Niacin Extended-Release Tablets, USP, 1,000 mg may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Fresh Roast Systems ColorTrack

The ColorTrack instrument could allow human access to infrared laser light levels in excess of its safety classification.

Moderate risk, FDA, Device defect

Halyard Pain, Towel, Drape and Eye Bag Packs

Sealed pouches in these packs were distributed without validated sterilization.

Moderate risk, FDA, Sterility problem

MOSAIQ Oncology Information System

Mosaiq Oncology Information System software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs.

Moderate risk, FDA, Software defect

Boston Scientific Orca Single Use Air/Water and Suction Valves

Orca Single Use Air/Water and Suction Valves have a higher than anticipated occurrence of the suction button sticking.

Moderate risk, FDA, Device defect

Merlin Patient Care System (PCS)

Software malfunction may occur during pacing capture threshold test of pacemaker, causing the programmer to not communicate the command to terminate the test.

Moderate risk, FDA, Software defect

Boston Scientific Neuromodulation Clik X Anchor

The Clik X Anchor may lack sterility assurance.

Moderate risk, FDA, Sterility problem

Boston Scientific CSK and TCN Electrodes

Reusable electrodes may not meet expected performance levels.

Moderate risk, FDA, Device defect

Fresenius Medical Care Holdings Bicarby Dialysate

Bicarby Dialysate has an error in its labeling of the GTIN, which may lead to unrecognized use of a potassium solution with a differing concentration.

Moderate risk, FDA, Labeling error

E & S Grocery & Bakery Taro Cakes

Taro Cakes contain an undeclared egg allergen.

High risk, FDA, Ended, Undeclared egg

9 recalls that day

Amneal Primidone Tablets

Primidone Tablets may be cross-contaminated with another drug.

Low risk, FDA, Contamination

Ascend Laboratories Minocycline Hydrochloride Extended-Release Tablets

Minocycline Hydrochloride Extended-Release Tablets failed a dissolution test.

Moderate risk, FDA, Drug dissolving problem

NEURO NOURISH Dietary Supplement

Neuro Nourish dietary supplement may have an off odor and bitter taste due to premature lipid oxidation.

Moderate risk, FDA, Quality problem

Zep Alcohol Sanitizer Spray

Zep Alcohol Sanitizer Spray has microbial contamination of sterile products.

Moderate risk, FDA, Sterility problem

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit contains an incorrect package insert.

Moderate risk, FDA, Device defect

DRAGONFLY Thai Ginger Powder

Dragonfly Thai Ginger Powder may contain lead.

Moderate risk, FDA, Ended, Chemical contamination

DT MedTech Hintermann Series Talar Implant

The Hintermann Series Talar Implant, Left, Size 2 contains a right implant device in its packaging.

Moderate risk, FDA, Labeling error

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC)

The Siemens Dimension Tacrolimus Flex Reagent Cartridge may show a positive bias in quality control and patient sample results.

Moderate risk, FDA, Device defect

Park St. Deli Macaroni & Cheese

Park St. Deli Macaroni & Cheese contains undeclared soy lecithin.

Moderate risk, FDA, Ended, Undeclared soy

10 recalls that day

Clover Hill Dairy Cheeses and Soft Ricotta

Clover Hill Dairy brand cheese may be contaminated with Listeria, which can cause serious infections.

High risk, FDA, Listeria

MMB of Louisiana Pasteurized Donor Human Milk

Pasteurized donor human milk may contain a dark spot, a potential physical contamination.

Low risk, FDA, Ended, Contamination

BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse

Saline nasal spray may contain Aspergillus spp. and could cause serious infections in at-risk people.

High risk, FDA, Contamination

ESTRELLA, Bebida de Parcha (Passion Fruit Drink)

Bebida de Parcha (Passion Fruit Drink) contains undeclared FD&C Red 40.

Low risk, FDA, Ended, Undeclared color or additive

Farm Rich Pizza Cheese Crunchers

Farm Rich Pizza Cheese Crunchers may contain metal pieces.

Moderate risk, FDA, Ended, Foreign object

Medartis APTUS Cannulated Compression Screws

Cannulated Compression Screws for bone fixation have an off-center cannulation.

Moderate risk, FDA, Device defect

EXENT Analyser

The EXENT Analyser may falsely detect or miss M-protein, and falsely elevate or decrease its concentration.

Moderate risk, FDA, Device defect

Galaxy RG Cakes, Rolls and Cheesecakes

Galaxy RG Cakes, Rolls and Cheesecakes contain undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Moderate risk, FDA, Ended, Undeclared color or additive

Sagemax Bioceramics NexxZr T Multi Dental Zirconia

NexxZr T Multi A3.5 W98-16mm dental discs may have a reduced or missing dentin layer, increasing fracture risk under stress.

Moderate risk, FDA, Device defect

Blood Bank of Hawaii Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor with travel history to a malarial endemic area but not assessed for residency.

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

6 recalls that day

Sun Pharmaceutical Industries Budesonide Inhalation Suspension

Budesonide Inhalation Suspension contains black/brown specs and particles in the ampoule solution.

Moderate risk, FDA, Foreign object

Breckenridge Duloxetine Delayed-Release Capsules

Duloxetine Delayed-Release Capsules contain an impurity above the recommended limit.

Moderate risk, FDA, Drug impurity

NeoSpan SuperElastic Compression Staple w/Instruments

The NeoSpan SuperElastic Compression Staple w/Instruments lacks the Magnetic Resonance Conditional Symbol on its packaging and labels.

Moderate risk, FDA, Labeling error

WeiKFiELD Custard Powder Kesar Pista

The ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pistachio.

Low risk, FDA, Ended, Labeling error

LifeServe Blood Center Red Blood Cells, Leukocytes Reduced, Irradiated

Red Blood Cells, Leukocytes Reduced, Irradiated were collected from a donor who had traveled to an area endemic for malaria.

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

Gulf Coast Regional Blood Center Red Blood Cells and Pooled Cryoprecipitated AHF

Red blood cells and pooled cryoprecipitate may have been prepared incorrectly.

Moderate risk, FDA, Ended, Hospital use

1 recall that day

BD ChloraPrep Clear Applicators

BD ChloraPrep Clear Applicators were recalled for lack of assurance of sterility or non-sterility.

High risk, FDA, Sterility problem

13 recalls that day

Nelson & Isa Lacteos Requeson Soft Ricotta

Requeson (soft ricotta) may be contaminated with Listeria, which can cause serious infections.

High risk, FDA, Listeria

Fresenius Kabi Epinephrine Injection

Fresenius Kabi Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial may contain more impurities than allowed.

Low risk, FDA, Drug impurity