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.
Sun Pharmaceutical is recalling Febuxostat 80 mg tablets due to microbial contamination in manufacturing equipment. Approximately 19,992 bottles were distributed nationwide.
C.R. Bard is recalling Bard Nasogastric Sump Tubes due to reports of inadequate or reduced suction, decompression, and drainage during use. The recall affects 57,159 units distributed in the United States.
Strides Pharma recalls Methoxsalen 10mg capsules (Lot #7253092B) due to failed dissolution specifications that could reduce medication effectiveness.
Lara's Bakery 3 LLC is recalling Tres Leches cake for undeclared wheat, a major allergen not listed despite being in the ingredient list. Consumers with wheat allergies could face allergic reactions.
B-K Medical A/S is recalling bkActiv Ultrasound System 2300 models because a measurement error could occur in the Dual Live Compare feature, potentially affecting diagnostic accuracy.
DiaSorin LIAISON HSV-2 Type Specific IgG test kits are being recalled because specific lots may produce false positive or equivocal results. Affected kits were distributed in the US and Canada.
C.R. Bard is recalling 26,100 nasogastric sump tubes due to user complaints of inadequate suction and reduced drainage. The malfunction could prevent proper stomach decompression.
C.R. Bard is recalling Bard Nasogastric Sump Tubes due to user complaints of inadequate suction and drainage during use. Approximately 6,600 units were affected.
DeIorio Foods has recalled frozen pizza dough sheets that may contain conveyor belt pieces. The recall affects products distributed in CA, NC, and PA with best-use dates of 02/16/2024.
IntegraDose Compounding Services recalled 281 syringes of Vasopressin 2 Unit/2 mL due to subpotency. The voluntary recall affects Lot #20230921VAS-2 distributed in Minnesota.
Sun Pharmaceutical recalls 6,552 bottles of Niacin Extended-Release Tablets (1000mg) nationwide due to microbial contamination in manufacturing equipment. No illnesses have been reported.
Lara's Bakery 3 LLC recalls Panque pound cake because the label declares gluten but omits wheat as a major allergen, with potential undeclared sesame, coconut, soy, milk, and eggs. Consumers with allergies should not consume this product.
Lidl US is recalling Duc De Coeur Camembert Cheese Croquettes due to possible contamination with Listeria monocytogenes. No illnesses have been reported.
Lecoq Cuisine Corporation is recalling RTB Mixed Danish Variety pastries due to undeclared soy lecithin. The recall affects 7,620 units distributed across 26 states.
Kent Imaging's Snapshot NIR tissue oxygenation measurement system touchscreens may become unresponsive, preventing users from viewing diagnostic oxygenation images. Fifty-seven units have been distributed across multiple US states and Malaysia.
Beckman Coulter is recalling 112 units of iQ200 Series Urine Microscopy Analyzers distributed globally. The cannula in the Flowcell and Rinse Waste Well Assembly may rust, potentially causing erroneous diagnostic results.
BE Pharmaceuticals recalls Fosaprepitant for Injection nationwide due to failed aseptic process validation. The 22,176 vials from lot #13D012AA may lack sterility assurance.
Medtronic is recalling Cobalt XT DR MRI implantable cardioverter defibrillators due to a manufacturing defect in the battery testing process. Some batteries may have bypassed required validation.
C.R. Bard is recalling Bard PreVent Anti-Reflux Filters with ENFit connectors due to user reports of inadequate or reduced suction, decompression, and drainage during use.
Beckman Coulter is recalling DxU 850m/840m Microscopy Analyzers (254 units) due to potential rust in the cannula component, which may cause erroneous test results. The recall affects units distributed in the US and multiple international locations.
Sedecal SA is recalling 845 Sedecal X Optima URS diagnostic x-ray systems after parts fell off the equipment, creating a safety risk to patients and users. The affected units were distributed in Alabama, Florida, and North Carolina.
Stonewall Kitchen is recalling Vermont Village Unsweetened Apple Sauce (24oz) because the product contains elevated levels of patulin, a mycotoxin. The recall affects 9,027 units distributed across 22 U.S. states.
Sun Pharmaceutical is recalling 1,728 bottles of Cinacalcet Tablets 60mg due to microbial contamination found in manufacturing equipment. No illnesses have been reported.
Sun Pharmaceutical is recalling Niacin Extended-Release Tablets nationwide due to microbial contamination found in manufacturing equipment. Affected lot numbers expire in June and July 2025.
Achieva 1.5T MR systems have incorrect warning labels on the Liquid Cooling Cabinet, missing the high voltage warning symbol. This presents a potential electrical shock risk for service personnel.