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 Midnight Bonbon due to undeclared allergens including soy, milk, and tree nuts. Consumers with allergies to these substances should not consume this product.
Dr. Rico Perez Super Kids Colostrum chewable tablets are being recalled because the product contains milk but does not declare this allergen on the label. Consumers with milk allergies may be at risk.
Mangetsu Ebisen 54g crackers are recalled because krill is present in the product but not listed in the ingredients statement, only in a general shellfish warning.
New Wave Endo-Surgical is recalling the M-Close Kit surgical suturing apparatus because the plastic housing may fracture. The recall affects 295 units distributed in Florida, Massachusetts, and Georgia.
Windy Hill Chocolate LLC is recalling Ginger Lime cookies due to undeclared allergens—soy, milk, and tree nuts. Consumers with sensitivities or allergies to these allergens should not consume the product.
Windy Hill Chocolate LLC is recalling Caramel Rum Truffle candies (Batch #1023220097) for undeclared soy, milk, and tree nut allergens. Affected consumers should not consume the product if they have allergies to these ingredients.
Ito confectionery vanilla cream is recalled because shea nut is not listed in the ingredients or allergen contains statement. Consumers with shea nut allergies may be at risk.
DAISO CALIFORNIA WAREHOUSE is recalling Kurata Foods Vegetable Potage V Ramen because coconut was not listed in the ingredients or allergen statement. The product was distributed across multiple U.S. states and British Columbia Canada.
Borris Brothers voluntarily recalls 55 containers of Smoked Swordfish Dip (8oz) distributed in Florida due to undeclared Yellow #5, a color additive that can trigger reactions in sensitive individuals.
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.
Windy Hill Chocolate LLC recalls Key Lime Bonbons due to undeclared allergens (soy, milk, tree nuts). Consumers with allergies should not consume this product.
Daiso California Warehouse is recalling Fujiya Country Ma'am Vanilla & Cocoa wafers because they contain peanut (sheanut) that is not declared on the label. Consumers with peanut allergies should not consume this product.
A firmware bug in Diagnostica Stago's STA Compact Max analyzer causes intermittent shortened coagulation times and frequent technical errors that produce inaccurate lab test results. Five units were distributed to clinical laboratories nationwide.
BD Pyxis automated dispensing cabinet software versions 1.7.0 through 1.7.4 experience download failures causing partial loss of patient information and transaction data. This may result in dispensing incorrect medication doses, allergenic medications, or discontinued medications.
Windy Hill Chocolate LLC is recalling Hazelnut Crunch (batch #1119220112) due to undeclared allergens: soy, milk, and tree nuts. Consumers with allergies to these ingredients should not consume the product.
Windy Hill Chocolate LLC is recalling Grand Marnier chocolate due to undeclared allergens: soy, milk, and tree nuts. Consumers with allergies to these substances should not consume the product.
Merit Medical Systems is recalling COBRA-OS Sheath Introducer Kits due to an incorrect needle size that may affect proper insertion during medical procedures.
Windy Hill Chocolate LLC is recalling Peanut Butter Praline due to undeclared allergens: soy, milk, and tree nuts. Consumers with these allergies should not consume the product.
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.
DAISO CALIFORNIA WAREHOUSE is recalling Ribbon raw thigh candy because fish is listed without identifying the species, creating uncertainty for consumers with fish allergies.
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 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.
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.