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.
Birch Benders Sweet Potato Pancake and Waffle Mix, 12 oz, is being recalled because of undeclared egg. The recall covers 5,340 cases.
Albertsons store-made Cheesecake Slice Colossal Dubai is being recalled because the contains statement does not declare pistachio. 32 units are affected.
Albertsons store-made Ready Meals Salad Fresh Berry & Chicken is being recalled because the contains statement does not declare walnut. 228 units are affected.
Albertsons store-made Boston Creme Dubai 5-inch cake is being recalled because the contains statement does not declare pistachio. 25 units are affected.
Albertsons store-made Platter Brownies Assorted Seasonal is being recalled because the contains statement does not declare walnut. 15 units are affected.
Albertsons store-made Kitchen Caesar Salads in large and small sizes are being recalled because the contains statement does not declare anchovy. 39 units are affected.
Albertsons store-made Cake Cravin Carrot 8-inch 1-layer is being recalled because the contains statement does not declare pecan. 138 units are affected.
Albertsons store-made Lox Avocado Toast is being recalled because the contains statement does not declare salmon. 19 units are affected.
Philips Azurion 7M20 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.
Standard and Pediatric Pasteurized Donor Human Milk is being recalled because the product is potentially contaminated with foreign material, specifically plastic particles.
Albertsons store-made Cake Pav Chocolate Lady Madeleines Strawberry is being recalled because the contains statement does not declare almond. Six units are affected.
Good Neighbor Pharmacy Extra Strength Antacid, calcium carbonate 750 mg chewable tablets, is being recalled because of the presence of small metallic particles.
Albertsons store-made Platter Pastry Mini Breakfast, 28 count, is being recalled because the contains statement does not declare almond. 75 units are affected.
Avanta Multi-Patient Administration Tube Sets are being recalled because supplier changes created a fit issue, so the stopcock cannot be reliably engaged with the Contrast Flow Control Valve.
Philips Azurion 7B20/15 systems with the Roadmap Pro software key are being recalled because a pedal tap may produce a dark image that is not clinically usable. 156 units affected.
Duloxetine DR Capsules, 30 mg, relabeled by Enovachem are being recalled over CGMP deviations and N-nitroso-duloxetine above the FDA acceptable intake limit.
Albertsons store-made Kitchen Salad Chicken Strip is being recalled because the contains statement does not declare almond. 55 units are affected.
Albertsons store-made Brie & Bleu Cheese Tray Large is being recalled because the contains statement does not declare almond. Eight units are affected.
Albertsons store-made Kale Berry Feta Salad is being recalled because the contains statement does not declare walnut. 31 units are affected.
Exacta Mix Vented Micro-Volume Inlet tubing sets are being recalled because affected lots may contain 0.8-micron filters in place of the validated 3-micron filters.
Lannett Niacin Extended-release Tablets, 1,000 mg, are being recalled after a stability test returned an out-of-specification low result for Stage 3 dissolution at 24 hours.
The BD Pyxis MedBank Mini medication cabinet is being recalled because the fingerprint scanner may overheat to a temperature capable of causing a first degree burn.
Albertsons store-made Oatmeal Raisin Cookies, 10 count, are being recalled because the contains statement does not declare almond. 62 units are affected.
Albertsons store-made Shrimp 41-50 P&D with Cilantro Lime Marinade is being recalled because the contains statement does not declare shrimp and anchovy.
Albertsons store-made Platter Catering Loaf Cake Slice is being recalled because the contains statement does not declare walnut. 92 units are affected.