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.
The Kitchen Garden Co, LLC is recalling Fine Sconehenge Baking Company Chocolate Chip Scones because they contain undeclared egg allergen. The product was misbranded and poses a risk to consumers with egg allergies.
The Kitchen Garden Co, LLC is recalling Fine Sconehenge English Scones due to undeclared egg allergen. The scones, sold via the firm's website to customers in California and Nevada, may pose a risk to consumers with egg allergies.
The Kitchen Garden Co, LLC is recalling Fine Sconehenge Lemon Raspberry Scones because they contain undeclared egg. People with egg allergies could have serious reactions.
Fine Sconehenge Baking Company is recalling Lemon Blueberry Scones sold through their website because they contain undeclared egg, a common allergen. Consumers with egg allergies should not consume this product.
Braga Fresh Foods is recalling Wegman's Organics Sweet Kale Chopped Salad Kit due to undeclared egg allergen. The product was distributed nationwide and may pose a risk to individuals with egg allergies.
Covidien recalls 5,709 stolen McGRATH MAC video laryngoscopes that failed quality tests. These defective devices risk failed intubation and may compromise airway management.
Randox Laboratories is recalling the RX Daytona Plus (without ISE) IVD Clinical Chemistry Analyzer due to a flaw in rerun settings that may cause incorrect test result reporting.
Corin Ltd recalled 3 Unity CR Femur knee implants due to labeling errors. Size 6 implants from batch 529803 may be labeled as size 7, and vice versa.
Coapt LLC is recalling the Dome Electrode Gen2 system due to potential burns or blistering from exposure to sunlight, warm temperatures exceeding 12 hours, or battery damage.
Nature's Path Organic Dark Chocolate Chip Waffles are recalled because peanuts were not declared on the label, posing a risk to consumers with peanut allergies.
GlaxoSmithKline is recalling TUMS Antacid tablets (Lot HA7G, expiration 8/31/2027) due to contamination with glass mineral wool. The product was distributed nationwide.
Randox Laboratories is recalling the RX Modena-IVD Clinical Chemistry Analyzer nationwide due to parameter re-run settings that may fail to function correctly when samples are outside the assay range, potentially resulting in incorrect test results.
RX Imola-IVD Clinical Chemistry Analyzers may report test results incorrectly when handling out-of-range samples due to improper parameter rerun settings. 35 units nationwide are affected.
GlaxoSmithKline recalls TUMS Antacid 1000 mg Assorted Berries chewable tablets (lot HR6A) due to presence of glass mineral wool. The product was distributed nationwide.
Sun Pharmaceutical is recalling 7,392 bottles of Liothyronine Sodium Tablets (Lot DND0058A) nationwide due to failed impurity and degradation specifications. Patients should contact their healthcare provider.
Select Custom Solutions is recalling JayRobb Vanilla Flavored Egg White Protein Powder due to plastic contamination. Approximately 1,008 pouches distributed nationwide are affected.
Covidien recalled 42,367 McGrath Mac 2 disposable laryngoscope blades due to an ineffective anti-fog agent that may cause screen condensation and visual obstruction during intubation procedures.
Siemens Cios Alpha (VA30) C-arm X-ray systems have a software issue that may not meet updated DIN and IEC standards. This defect could result in patient misdiagnosis or unnecessary repeat imaging.
Padagis US LLC is recalling Gynazole 1 butoconazole nitrate vaginal cream nationwide due to a manufacturing error where hydrophilic colloidal silica was used instead of hydrophobic colloidal silica.
GlaxoSmithKline is recalling TUMS Antacid (1000mg Calcium Carbonate) due to the presence of glass mineral wool. The affected lot (HV6B) was distributed nationwide.
GlaxoSmithKline is recalling TUMS Antacid tablets (Lot HB2G) due to glass mineral wool contamination. Affected product was distributed nationwide.
Pepsi Beverages is recalling Crush Orange Soda 24-packs due to plastic foreign material found in some cans. The recall affects 184 cases distributed in Minnesota with lot code JUL2924XXXXMC10243 and a best-by date of July 29, 2024.
GlaxoSmithKline is recalling TUMS antacid tablets in Lot KH5L due to glass mineral wool contamination. Affected consumers should stop use immediately.
Rise Baking Company is recalling Favorite Day Bakery demi French bread sold at Target due to plastic contamination. The affected bread poses a choking hazard and was distributed in California and Iowa.
MicroVention is recalling 14 units of the AZUR CX 35 Peripheral Coil System due to unsealed pouch packaging that could compromise device sterility. The affected units were distributed across eight states.