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.
Queen Bee Gardens is recalling QBee Honeycomb Toffee Milk due to undeclared tree nuts. Consumers with tree nut allergies face a potential allergic reaction risk.
GE Healthcare's SIGNA Premier MRI scanner is being recalled because under rare conditions, the gradient coils can produce elevated acoustic noise that could potentially cause hearing loss with prolonged exposure.
Queen Bee Gardens is recalling Honey Caramels Red Raspberry because the product may contain undeclared tree nuts. The recalled items were distributed to Queen Bee retail stores in Colorado, New Mexico, and Wyoming, and nationwide via internet sales.
Aesculap is recalling AESCULAP S4 Cervical Cross Connectors used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to loosen or shift on the spinal rods.
Becton Dickinson is recalling certain BD Connecta Plus1 360 Blue Blend infusion connectors due to potential leakage at the housing stopcock that could interrupt treatment and expose patients to contamination and biohazardous material.
Queen Bee Gardens is recalling Honeymoons Dark Chocolate Almond for undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. The product was distributed to retail locations in Colorado, New Mexico, and Wyoming, and nationwide online.
Nephron Sterile Compounding Center is recalling 64,365 syringes of Neostigmine Methylsulfate Injection nationwide due to lack of assurance of sterility. Patients using affected lots should contact their healthcare provider.
Queen Bee Gardens is recalling Honey Caramels Cinna Honey due to potential undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts). Affected products were sold at 10 retail locations in Colorado, New Mexico, and Wyoming, as well as nationwide via internet.
Queen Bee Gardens, LLC is recalling Honey Caramels Creamy Fudge because the product may contain undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, and walnuts). People with tree nut allergies should not consume this product.
DePuy Orthopaedics is recalling 872 units of the ATTUNE Measured Sizing and Rotation Guide due to a manufacturing defect. A galvanized steel spring was used instead of stainless steel, which may cause corrosion and surgical complications.
Becton Dickinson is recalling its BD Connecta Stopcock due to potential leakage at the housing component, which may interrupt treatment and cause exposure to biohazardous material.
Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 5,495 pre-filled syringes distributed nationwide.
Queen Bee Gardens is recalling Honey Caramels Huckleberry (5.87 oz) because they may contain undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. This poses a serious health risk to people with tree nut allergies.
LumiraDx recalled SARS-CoV-2 Antibody Test Strips after discovering modifications were made outside the FDA-approved Emergency Use Authorization scope. The recall affects 635 units in 13 states.
Launch Sequence Capsules, a dietary supplement sold in 60-count bottles, were recalled because they were marketed without FDA approval as a drug based on label claims.
Queen Bee Gardens is recalling Honeymoon Cinna-Bee Patties due to potential undeclared tree nuts: pecans, almonds, coconut, macadamia nuts, and walnuts. Products were distributed in Colorado, New Mexico, Wyoming, and nationwide online.
Queen Bee Gardens is recalling Honeymoons Milk Chocolate Almond candy due to undeclared tree nuts including pecans, almonds, coconut, macadamia, and walnuts. The product was distributed in Colorado, New Mexico, Wyoming, and nationwide online.
Revive Superfoods Strawberry Zen smoothie mix is being recalled due to potential norovirus contamination in IQF raspberries used as an ingredient. The recall affects 57,960 units distributed to consumers in Pennsylvania, California, Illinois, and Texas.
Queen Bee Gardens is recalling Honeymoons Ivory Chocolate Pecan due to undeclared tree nuts, which may affect consumers with tree nut allergies. The product was sold at retail locations in Colorado, New Mexico, and Wyoming, plus nationwide internet sales.
Apotex Corp. is recalling 2,010 bottles of Aripiprazole Tablets 20mg nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting medication effectiveness.
Queen Bee Gardens is recalling Dark Raspberry Classic snacks due to undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts) that may be present, posing a risk to consumers with tree nut allergies.
Becton Dickinson is recalling specific lots of Nexiva IV catheters because the stopcock housing may leak, potentially interrupting treatment and exposing patients to infusate and biohazardous material.
Revive Organics is recalling Revie Superfoods Raspberry & Mango Smoothie products because they may contain norovirus from contaminated raspberries. Consumers in PA, CA, IL, and TX who have purchased this product should not consume it.
Nephron Sterile Compounding Center is recalling 3,740 HYDROmorphone injection syringes due to lack of assurance of sterility. The affected lot was distributed nationwide.
Chuckanut Bay Foods LLC is recalling New York Cheesecake Bites because the label declares sunflower lecithin when the product actually contains undeclared soy lecithin, posing a risk to consumers with soy allergies.