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.
Windy Hill Chocolate LLC recalls Key Lime Bonbons due to undeclared allergens (soy, milk, tree nuts). Consumers with allergies should not consume this product.
Windy Hill Chocolate LLC recalls Midnight Bonbon due to undeclared allergens including soy, milk, and tree nuts. Consumers with allergies to these substances should not consume this product.
Windy Hill Chocolate LLC is recalling Sunrise Mimosa chocolate due to undeclared allergens: soy, milk, and tree nuts. Consumers with allergies or sensitivities to these ingredients should not consume this product.
Daiso California Warehouse is recalling Wadakan sukiyaki sauce due to incomplete allergen labeling. The product lists fish in the ingredients and contains statement but does not specify the fish species.
Takuma food dashi salt peanut 80g is being recalled because the product contains flying fish instead of angler fish. Consumers who purchased this product should stop using it.
Borris Brothers voluntarily recalled Smoked Mahi Dip (8oz and 48oz) in Florida due to undeclared Yellow #5 food dye. Consumers sensitive to this color additive should not consume the product.
The Harvard Drug Group recalled 3,984 cartons of Gabapentin 600 mg tablets distributed nationwide due to a product mixup where one foreign tablet was found.
Apotex Corp. recalls Calcitonin Salmon nasal spray (82,375 bottles) nationwide due to a glass splinter entrapped in the pump mechanism. The defect renders the nasal spray inoperable.
Daisho Kimchi hotpot soup is recalled due to incomplete allergen labeling. The label warns for fish but does not specify anchovy or sardine, and the Canadian product lists clams in ingredients but not in the allergen statement.
DAISO CALIFORNIA WAREHOUSE is recalling Ribbon raw thigh candy because fish is listed without identifying the species, creating uncertainty for consumers with fish allergies.
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.
Tandoori Roasted Peanuts in 4.94 oz pouches are recalled due to undeclared milk. Consumers with milk allergies should not consume the 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.
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 is recalling Dark Chocolate Goldenberry Bites due to undeclared milk. The product poses a serious 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.
Salento Organics Dark Chocolate Pitaya Bites are recalled for undeclared milk. 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.
Salento Organics Dark Chocolate Mango Bites are recalled due to undeclared milk, which poses a risk to consumers with milk allergies.
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.
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.
Tandoori Peanut Spread is being recalled due to undeclared milk allergen. The product poses a risk to consumers with milk allergies.
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.
Scarpetta brand Pink Pesto Pasta Sauce contains undeclared pine nuts. Consumers with tree nut allergies are at risk of allergic reactions.
Salento Organics is recalling Dark Chocolate Peanut Bites due to undeclared milk. Consumers with milk allergies should not consume this product.