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.
Nitto Foods Immediately Pickled Dashi (5.5g x 2 bags, UPC 4902362032100) is being recalled due to labeling inconsistencies related to fish ingredients. The product was distributed across multiple US states and British Columbia.
Salento Organics has recalled Dark Chocolate Pineapple Bites due to undeclared milk. The affected product contains milk not identified on the label, posing a risk to consumers with milk allergies.
Salento Organics is recalling Dark Chocolate Peanut Bites due to undeclared milk. Consumers with milk allergies should not consume this product.
Tandoori Roasted Chana (chickpeas) from Jabsons Foods is recalled because it contains undeclared milk, a major allergen. Consumers with milk allergies should not consume this product.
Salento Organics is recalling Dark Chocolate Goldenberry Bites due to undeclared milk. The product poses a serious risk to consumers with milk allergies.
Salento Organics is recalling Dark Chocolate Banana Bites due to undeclared milk content, a major allergen. The recall affects multiple lot numbers distributed domestically and internationally.
Salento Organics Dark Chocolate Pitaya Bites are recalled for undeclared milk. The product poses a risk to consumers with milk allergies.
The FDA recalls NUX Male Enhancement capsules distributed nationwide because they contain undeclared sildenafil and tadalafil, making them an unapproved drug. Consumers should not use this product.
Jabsons Foods is recalling Thai sweet Chilli Roasted Peanut due to undeclared milk. The recall affects 508 cases distributed domestically in the United States.
Tandoori Roasted Peanuts in 4.94 oz pouches are recalled due to undeclared milk. Consumers with milk allergies should not consume the product.
Tandoori Peanut Spread is being recalled due to undeclared milk allergen. The product poses a risk to consumers with milk allergies.
Pro Power Knight Plus capsules contain undeclared sildenafil and tadalafil, prescription ingredients not listed on the label. The product was marketed as an unapproved drug and poses safety risks.
DYNAMITE SUPER capsule is being recalled nationwide because it was marketed without FDA approval and contains undeclared sildenafil and tadalafil, active ingredients used in sexual enhancement products.
Jabsons Foods has voluntarily recalled Tandoori Kaju Cashew Nuts because the product contains undeclared milk, a common allergen. This is a Class I recall affecting consumers with milk allergies.
Salento Organics Dark Chocolate Mango Bites are recalled due to undeclared milk, which poses a risk to consumers with milk allergies.
Scarpetta brand Pink Pesto Pasta Sauce contains undeclared pine nuts. Consumers with tree nut allergies are at risk of allergic reactions.
Bakery 37 Inc is recalling Blue Moon Bakery Legendary Breakfast Cookies because they contain undeclared sesame. The cookies were distributed in Oregon and may pose a risk to consumers with sesame allergies.
Blue Moon Bakery Choconut Breakfast Cookie is being recalled because sesame is not listed in the Contains statement on the label, despite being present in the product. Consumers allergic to sesame may consume the product unknowingly.
Cargill is recalling PROSANTE soy flour products labeled gluten-free because they may contain gluten levels above 20 ppm, the FDA's regulatory threshold for gluten-free labeling. Products were distributed nationwide and internationally.
Give & Go Prepared Foods is recalling H-E-B Bakery Two-Bite Brownies due to potential soft rubber fragments that could pose a choking hazard. The recall affects 3,607 cases distributed in Texas.
Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of early aseptic loosening caused by inadequate surgical technique. Training on improved surgical technique is being provided.
Weleda Inc is recalling Hepatodoron® tablets due to potential metal contamination. The affected batch (J033, expiring January 31, 2027) was distributed nationwide.
Cargill is recalling Prosante TVGPTN food products labeled as gluten-free that may contain gluten above 20 ppm.
A firmware bug in Inpeco laboratory automation modules may cause sample misidentification, leading to incorrect electrolyte test results and potential treatment errors.
Linkbio Corp. is recalling 14 units of LINK SLED Knee System implants due to risk of early aseptic loosening or wear from suboptimal positioning or inadequate cementing. Updated surgical technique training is being issued.