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.
El Ruisenor De Mexico, Inc. is recalling 1,354 pounds of bread crumbs for containing undeclared milk, wheat, sesame, and soy.
Medtronic is recalling CareLink Clinic software version 4.4A because a defect in the Settings Calculator feature may result in incorrect rapid-acting insulin parameters.
AVID Medical, Inc. is recalling 56 Halyard Anterior Hip Packs because a non-sterile component was not properly sterilized.
Primal Supplements Group LLC is recalling Primal Herbs Volume herbal supplement because FDA analysis confirmed it contains sildenafil, which is not listed on the label.
Ventec Life Systems is recalling 100 units of ventilator parts because the internal flow transducer cable connector may disconnect, potentially interrupting ventilation therapy.
Medtronic is recalling the MiniMed Go app version 1.2.1 because a software defect prevents long-acting insulin dose reminders from appearing, potentially leading to missed or duplicate doses.
El Ruisenor De Mexico, Inc. is recalling 844 pounds of Homestyle Poblano Mole because it contains undeclared sesame, peanuts, wheat, soy, and sulfites.
Pacific Health Sciences is recalling 953 units of Babies' Magic Tea Baby Sleep Gripe Water due to elevated alcohol levels. The product was sold in Florida via Amazon and the customer's website.
El Ruisenor De Mexico, Inc. is recalling Special Red Almond Mole Powder due to undeclared allergens, including sesame, peanuts, and wheat.
Right Value Drug Stores LLC is recalling 4,675 vials of compounded Testosterone Cypionate due to a lack of sterility assurance.
Pfizer is recalling 134 bottles of Levoxyl (levothyroxine sodium) 175 mcg tablets due to confirmed subpotency. The product was distributed nationwide and in Puerto Rico.
Ventec Life Systems is recalling 1,532 VOCSN ventilator parts because an internal cable connector may disconnect, potentially interrupting ventilation therapy.
Ventec Life Systems is recalling V+Pro ventilators because an internal cable may disconnect, causing system reboots and interruption of therapy.
Ventec Life Systems is recalling VC+Pro ventilators because an internal cable may disconnect, causing system reboots and interruption of therapy.
Voila Juice Company is recalling Andronico's 100% Squeezed Orange Juice because the product was not processed to achieve the required 5-log pathogen reduction.
Trader Joe's is recalling Crispy Rice Milk Chocolate Bars because the outer label is incorrect and fails to declare wheat as an ingredient.
El Ruisenor De Mexico, Inc. is recalling Fritura Rueda Wheat Wheel Snacks because they contain undeclared wheat, Yellow #5, and Yellow #6.
El Ruisenor De Mexico, Inc. is recalling dried pineapple rings because they contain undeclared sulfites, a common allergen.
El Ruisenor De Mexico, Inc. is recalling Jovy Gummy Worms Neon due to undeclared artificial dyes. The product was distributed primarily in California and limited areas in other states.
El Ruisenor De Mexico, Inc. is recalling 2,935 pounds of dried mango slices because they contain undeclared sulfites and Yellow #6. Consumers should stop eating the product and return it to the store.
El Ruisenor De Mexico, Inc. is recalling dried peaches because they contain undeclared sulfites. The product was distributed primarily in California and limited to other states.
El Ruisenor De Mexico, Inc. is recalling 300 pounds of all-purpose flour due to an undeclared wheat allergen. The product is sold in 1lb, 5lb, and 50lb clear plastic units.
El Ruisenor De Mexico, Inc. is recalling Dried Fruit Mix because it contains undeclared sulfites and Yellow #6. The product was distributed primarily in California and limited areas in other states.
El Ruisenor De Mexico, Inc. is recalling Churro Mix because it contains undeclared egg and wheat ingredients.
El Ruisenor De Mexico, Inc. is recalling specific lots of roasted mixed nuts because they contain undeclared cashew, almond, Brazil nut, hazelnut, and pecan.