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.
Pepsico is recalling Lipton Diet Green Tea Citrus 24-packs due to undeclared aspartame and missing phenylketonuria warning on the bottle. Those with PKU must avoid the product.
Rader Farms Organic Fresh Start Smoothie, a frozen fruit and vegetable blend, has been recalled due to potential Hepatitis A contamination. The recall affects 62,380 bags distributed across 31 states.
Delsam Pharma's Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. Consumers should stop using affected products immediately.
SANTOS FROZEN FOODS is recalling Jumbo Deviled Crabs (6oz packages) because they contain undeclared milk and sesame seeds. Consumers with allergies or sensitivities to these allergens should not consume this product.
Cipla USA is recalling 278,538 albuterol sulfate inhalers nationwide with specific lot numbers due to defective valve gaskets that cause empty inhalers or medication leakage. Check your lot number and contact your healthcare provider if affected.
Honey mustard pretzel products from multiple brands are being recalled due to potential undeclared milk. The recall affects 334,357 bags distributed nationwide.
Dakota Style, Inc. is recalling salt and vinegar pretzel products nationwide because they may contain undeclared milk. Consumers with milk allergies should not consume these products.
Dakota Style, Inc. is recalling multiple brands of dill pickle pretzels nationwide because they may contain undeclared milk, a major allergen. Consumers with milk allergies should not consume these products.
SANTOS FROZEN FOODS is recalling Regular Deviled Crabs (4oz) for undeclared milk and sesame allergens. Approximately 520 cases were distributed domestically in affected lots beginning with 23 and ending in 03, 04, or 05.
Abbott is recalling the Amplatzer Steerable Delivery Sheath (ASDS), a cardiac catheter, due to a 0.77% reported incidence rate of air embolism during procedures. The recalled 675 units are distributed worldwide.
SANTOS FROZEN FOODS is recalling Mini Deviled Crabs, 1oz, due to undeclared milk and sesame seeds. Consumers with allergies to these allergens should not consume the product.
Walmart's Great Value Sliced Strawberries are being recalled due to potential Hepatitis A contamination. Approximately 28,650 bags distributed across 32 states are affected.
Baxter is correcting false upstream occlusion alarms in SIGMA Spectrum and Spectrum IQ infusion pumps following software upgrades affecting approximately 3,306 units distributed nationwide in the US.
Oregon Potato Company is recalling frozen berry products distributed nationwide under multiple brand names due to potential Hepatitis A contamination. Consumers who have purchased these products should not consume them.
EzriCare Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. The FDA identified non-sterile products that could pose a risk to eye health.
Wawona Frozen Foods recalls Organic Daybreak Blend frozen strawberries sold at Costco due to potential Hepatitis A. Approximately 9,878 cases were distributed to Costco locations in five western states with lot codes dated through October 2023.
Gelson's Sea Salt Pretzels are being recalled nationally because they may contain undeclared milk. This poses a hazard to consumers with milk allergies.
FMA International LLC is recalling Fromagerie Ottavi Tome Corse Sheep Milk Cheese due to Listeria monocytogenes contamination. The product was distributed in Oregon.
The Draeger Oxylog 3000 Plus emergency and transport ventilator may stop working when transitioning from battery to AC operation. Approximately 300 units distributed nationwide and internationally are affected.
Walmart is recalling Great Value Mixed Fruit due to potential Hepatitis A contamination. The frozen product was distributed across 33 states; consumers should not consume it.
The FDA has issued a Class I correction for Baxter's Spectrum IQ Infusion System due to increased false upstream occlusion alarms following software updates. Approximately 19,861 units are affected nationwide.
Great Value Antioxidant Fruit Blend frozen berries are being recalled due to potential Hepatitis A contamination. The affected product was distributed across multiple states through Walmart, HEB, and Costco.
BASIC CARE ALLERGY (fexofenadine hydrochloride) 180 mg tablets are being recalled nationwide due to failed impurities and product degradation specifications. Approximately 11,904 cartons were affected.
Medline is recalling Non-Sterile PVP Solution Hystero Pack kits due to mislabeling: affected lots labeled as 'Sterile' when actually 'Non-Sterile'. Using non-sterile solution in sterile gynecological procedures creates infection risk.
Stryker Power-PRO 2 ambulance cots may develop bent base leg assemblies, risking cot tips, unstable motion, and operational difficulties. Approximately 1,980 units were recalled.