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.
Mennel Milling Company is recalling approximately 2.6 million pounds of PIZZA 50/50 UNMALTED flour due to potential contamination with metal, wood, gasket material, and sifter balls.
Mennel Milling Company recalled I-52 Patent Flour containing potential foreign material including metal, wood, gasket material, and sifter balls. The flour was distributed in bulk trailers across six states.
Mennel Milling Company is recalling its milling product (2-15969-0000) due to potential contamination with metal, wood, gasket material, and sifter balls. The product was distributed across Kentucky, Michigan, New Jersey, New York, Ohio, and Pennsylvania.
Philips is recalling 14 units of its Azurion 3 surgical imaging system due to a potential short circuit in the power inverter. The defect could cause the device to lose power and fail during surgical procedures.
Lupin Pharmaceuticals recalls Voriconazole for Oral Suspension (40mg/mL) due to missing or incorrect package inserts on affected batches distributed in Ohio, Illinois, and New Jersey.
W&H Surgical handpiece S-12 devices were incorrectly laser marked with '1:1' instead of the correct '1:2' during production. 160 units are affected.
Amneal Pharmaceuticals is recalling 46,037 bottles of Oseltamivir Phosphate Oral Suspension due to failed quality test results showing impurities and degradation. The FDA classified this as a Class II recall affecting nationwide distribution.
Meta Psyllium Fiber Capsules in 100 and 160 count bottles are being recalled because the product labeling is illegible. Approximately 21,428 cases were distributed across most US states.
Medline is recalling 1.3 million units of bleach germicidal wipes due to stability concerns. Products labeled for 24-month shelf life are only safe and effective for 12 months.
Mennel Milling Company is recalling approximately 2.6 million pounds of bulk milling product due to potential contamination with foreign materials including metal, wood, and gasket material distributed across six states.
Pure Care Foaming Mint Hand Sanitizer has been voluntarily recalled due to manufacturing process deviations. The product was distributed to accounts in North Carolina and Michigan.
Al Amir Fresh Foods Baba Ghannooj Grilled Eggplant is recalled for undeclared sesame. The product contains tahini but the label does not list sesame as an ingredient, posing a risk to consumers with sesame allergies.
GE Healthcare is recalling 1,410 neonatal incubators worldwide because bedside panels and portholes can appear closed while not properly latched. If impacted, they may fall open and fail to protect patients from falls.
GE Healthcare incubator hoods can appear closed but may not be properly latched, posing a fall risk if patients impact an unsecured panel.
Utz Wavy Originals Potato Chips (2.75 oz) distributed in New York may contain undeclared milk and could pose a risk to people with milk allergies.
Hans Kissle Company is recalling Mexican Style Quinoa Salad due to undeclared soy and egg allergens. The product was distributed in the Northeast and may pose serious risk to consumers with allergies.
GE Healthcare is recalling neonatal incubators because the bedside panel can appear closed while unlatched. Impact could cause it to fall open, risking patient injury.
GE Healthcare incubators have defective bedside panels that may appear closed but not be properly latched, creating a patient fall risk when the panels disengage upon impact.
U.S. Tov, Inc. is recalling Dragonfly Jelly Bar Handbags and Backpacks due to a potential choking hazard from konjac. The products were distributed nationwide.
Fresh Express Kit Salsa! Ensalada salad kits are recalled for potential Listeria monocytogenes contamination in the cheese condiment. The affected 12.1 oz bags were distributed to AL, FL, GA, CA, UT, WA, and Canada.
Al Amir Fresh Foods Harissa Spicy Hummus With a Kick is being recalled due to an undeclared sesame allergen. The product declares tahini but not sesame, which could cause serious allergic reactions in people with sesame sensitivity.
The bedside panel on GE Healthcare Care Plus incubators may appear closed while unlatched. If impacted, the panel can fall open, exposing patients to injury risk.
Impella cardiac catheters are being recalled due to risk of left ventricle perforation during operator use. The FDA has classified this Class I recall affecting 91,914 units worldwide.
Byrne Dairy, Inc is recalling Mighty Fine Chocolate Ice Cream because it contains undeclared peanuts. Consumers with peanut allergies should not consume this product.
Al Amir Fresh Foods Classic Hummus Creamy Garbanzo is recalled because it contains sesame (tahini) but the label does not declare sesame as an allergen. Consumers with sesame allergies may experience allergic reactions.