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.
Accord Healthcare recalls Pirfenidone tablets due to manufacturing practice deviations found during FDA inspection. The recall affects 2,614 cartons distributed in the US, Puerto Rico, and Canada.
Accord Healthcare recalls Glycopyrrolate injection due to manufacturing practice deviations found during FDA inspection. The recall affects 3,164 vials distributed in the US, Puerto Rico, and Canada.
Accord Healthcare is recalling rosuvastatin 40 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing quality control deviations found during an FDA inspection. No illnesses have been reported.
Accord Healthcare is recalling Atorvastatin Calcium 10 mg tablets distributed in the United States, Puerto Rico, and Canada following FDA inspection findings of manufacturing deviations.
Accord Healthcare is recalling Glimepiride 4 mg tablets due to Current Good Manufacturing Practice deviations discovered during an FDA inspection. Approximately 1.16 million bottles across the United States, Puerto Rico, and Canada are affected.
Accord Healthcare is recalling 8,184 bottles of Ropinirole 4 mg tablets due to manufacturing practice deviations found during an FDA inspection. The recalled batches were distributed in the United States, Puerto Rico, and Canada.
Corim Industries is recalling Agglomerated Peanut Butter Hot Chocolate and Peanut Butter Cappuccino products in multiple formats due to undeclared peanut allergen on the label.
Accord Healthcare is recalling Pirfenidone 801 mg tablets due to Current Good Manufacturing Practice deviations identified during an FDA inspection. Affected batches P2202519 and P2202513 were distributed in the United States, Puerto Rico, and Canada.
DuPont Nutrition USA is recalling BD-102 NF Microcrystalline Cellulose, a pharmaceutical excipient, due to failed conductivity specifications. Affected batches were distributed nationwide and internationally for use in drug manufacturing.
DuPont is recalling Avicel PH-200, a pharmaceutical excipient, because test results showed conductivity out of specification. No illnesses or injuries have been reported.
Harvest Biscuits 4Kinds of Nuts (94g units) are recalled because the product contains soy and peanuts that are not listed on the ingredient label. The product was distributed to Daiso stores across multiple US states and Canada.
Daiso is recalling KASHIWADO Hitoritoiro Fly Beans Senbei because the product contains peanuts not listed on the label, creating a risk for consumers with peanut allergies.
Rao's Made for Home Slow Simmered Soup labeled as Chicken & Gnocchi is being recalled because it actually contains vegetable minestrone with an undeclared egg allergen. The recall affects 13,751 cases distributed across multiple states.
Daiso is recalling Harvest Sesame 94g units due to undeclared soy and sesame allergens on the label. The recall affects 317,751 units distributed across Daiso retail locations in six U.S. states and Canada.
Draeger Medical recalls NovaStar TS Anti-Asphyxia Valves due to magnets that may interfere with implanted and non-implanted medical devices and metallic implants.
Daiso potato crackers with sardines (46g) are being recalled due to undeclared milk allergen. The product was distributed across six US states and parts of Canada.
Pilgrim's Roasted Nut'Z Squirrel Mix (8 oz bags) is recalled for undeclared milk, soy lecithin, and food colors. The product poses allergic reaction risk to consumers with milk or soy allergies.
DAISO CALIFORNIA WAREHOUSE is recalling MEITO Powdered Apple Tea 4packs because the product contains milk that is not declared on the label. Consumers with milk allergies should not consume this product.
Pilgrim's Roasted Nut'Z English Toffee Peanuts (580 packages) are recalled because the label does not declare the presence of milk. Consumers with milk allergies should not consume this product.
KASHIWADO Hitoritoiro Fly Beans Senbei crackers are being recalled because the product contains peanuts that are not listed on the ingredient label. Consumers with peanut allergies should avoid this product.
DAISO CALIFORNIA WAREHOUSE is recalling ITOSEIKA Chocolate Chip Cookies due to undeclared milk allergen on the label. Products were distributed to Daiso stores in California, Washington, Nevada, Texas, New York, New Jersey, and British Columbia.
Pilgrim's Roasted Nut'Z Chocolate Toffee Almonds are recalled due to undeclared milk and soy lecithin. The product poses a serious risk to consumers with dairy and soy allergies.
KANRO Pure gummy candies are being recalled due to undeclared soy allergen on the label. The recall affects 113,205 units sold at Daiso stores across multiple states and Canada.
Daiso California Warehouse is recalling Katoseika Chocolat Orange Candy (60g) due to undeclared soy allergen. The product was distributed to Daiso stores across multiple U.S. states and Canada.
Caramel Corn Boys Festival snack packs, distributed to Daiso stores, contain undeclared almonds and peanuts. This creates serious health risks for consumers with nut allergies.