Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Philips recalls Azurion imaging systems because the foot switch pedal may stick in the active position, causing unintended radiation emission. Facilities should stop using the systems and contact Philips for guidance.
Marlex Pharmaceuticals is recalling Digoxin Tablets because bottles labeled as 0.125mg contain 0.25mg strength, and vice versa. Approximately 94 100-count bottles distributed nationwide are affected.
Philips Allura Xper X-ray imaging systems are being recalled because the foot switch pedal may become stuck in the active position, potentially causing unintended radiation emission. The recall affects 5,432 systems distributed nationwide.
Aomori Olympus recalls 1,252 reusable distal attachment devices with DEHP chemical levels exceeding safe exposure limits per medical device standards. Devices distributed nationwide in the United States.
Cooperstown Cheese Company recalled 12 cheese varieties distributed in New York due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.
Philips MultiDiagnost-Eleva imaging systems may emit unintended radiation if the foot pedal gets stuck in the active position. The FDA is alerting healthcare facilities to this potential equipment malfunction.
Aomori Olympus Co., Ltd. recalls 1,048 Olympus Distal Attachment units used in EMR kits due to di-2-ethylhexyl phthalate (DEHP) exceeding permissible exposure limits per ISO 10993-17: 2002. Devices were distributed nationwide.
Nestle USA is recalling Toll House Chocolate Chip Cookie Dough due to potential wood fragments. The recall affects 147,816 packages distributed across multiple U.S. states.
Milrinone Lactate Injection is recalled due to failed impurity and degradation specifications. The affected lot should not be used.
ZVU Functional GI Software labeled as revision 3.3.0 is incorrectly labeled; it actually contains revision 3.2.0. The mislabeling affects 20 units distributed from May to July 2023.
Ascend Laboratories is recalling Fosfomycin Tromethamine antibiotic granules nationwide due to organic impurities exceeding acceptable levels in stability testing. No illnesses have been reported.
Ruby Mountain Spring Water 3 and 5 gallon jugs are recalled due to positive coliform findings. Consumers should not drink the water.
PBM Nutritionals recalls Parent's Choice and Tippy Toes Sensitivity Premium Infant Formula due to inadvertent market release of product that had been rejected. Affected batches were distributed across multiple states.
AvKARE is recalling Sodium Fluoride 1.1% prescription dental toothpaste because cartons are labeled as Capsaicin Cream 0.025%, though the tubes are correctly labeled. Approximately 35,184 tubes have been distributed to 19 consignees.
Esperion is recalling Nexlizet (bempedoic acid and ezetimibe) tablets nationwide due to failed dissolution specifications identified during stability testing. Approximately 45,240 bottles are affected.
Datascope's Cardiosave Hybrid Intra-Aortic Balloon Pumps may trigger unexpected alarms indicating gas loss or gain due to undocumented causes including patient movement and blood in the circuit. The FDA Class I recall affects 9,175 units.
Datascope Corp. is recalling 9,175 units of Cardiosave Rescue IABP devices because batteries will not charge if the console is not fully inserted into the hospital cart. Users were often unaware of this insertion requirement.
Datascope Corp. is recalling approximately 9,175 Cardiosave Rescue IABPs because unexpected gas-loss and gas-gain alarms may occur during therapy due to patient movement, blood in the circuit, and hardware issues.
Olympus Corporation recalls 6,426 units of the EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to recent reports of patient infections. The device was distributed nationwide in the United States.
The FDA is recalling Vegetal Vigra 200mg capsules nationwide because they contain sildenafil, an active ingredient in FDA-approved medications. The product was marketed without FDA approval.
Stonewall Kitchen brand Peanut Butter Maltballs (6oz) may contain undeclared peanut, soy, and wheat. Consumers with allergies to these ingredients should not consume this product.
The Cardiosave Hybrid Intra-Aortic Balloon Pump console fails to charge if not fully inserted into the hospital cart. Users unaware of this requirement may attempt to use a non-charged device during critical cardiac care.
Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps due to autofill failures that can cause the pump to stop.
Datascope Corp. is recalling Cardiosave Hybrid intra-aortic balloon pumps due to autofill failure causing pump stops. The FDA Class I recall affects approximately 9,175 units distributed nationwide.
Datascope is recalling Cardiosave Hybrid intra-aortic balloon pumps due to reported temperature alarms that can cause loss of pumping function or unexpected standby mode. Users have reported these system failures in critical cardiac support devices.