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.
Fairhope Roasting Company is recalling its Cold Brew Coffee Concentrate distributed in Alabama for food service because the label is missing a required "Keep Refrigerated" statement.
Lucky Super Soft Antifungal Athlete's Foot Cream, clotrimazole 1%, is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 1,102 tubes affected.
United Salt Corp is recalling salt because plain salt was labeled as iodized and iodized salt was labeled as plain, a mislabeling issue.
Focalin XR 5 mg extended-release capsules are being recalled over a labeling issue: incorrect or missing lot number and/or expiry date. 7,803 bottles are affected.
Whole Foods Market Kitchens Vegetarian Minestrone Soup, 24 oz, is being recalled because it contains undeclared shrimp. 562 cases, or 4,496 units, are affected.
HH Fresh Trading Corp. enoki mushrooms, 150 g, are being recalled after imported enoki mushrooms tested positive for Listeria monocytogenes. 120 cases are affected.
Beekeeper's Naturals Saline Nasal Spray with propolis and xylitol, 1 fl oz, is being recalled for microbial contamination of non-sterile products. 1,680 bottles are affected.
Taro Cakes are being recalled because of an undeclared egg allergen. The action covers 300 units across all lot codes.
Gas-X Extra Strength simethicone 125 mg softgels are being recalled because of contamination with a diluted propylene glycol-based coolant leaked from a machine during packaging.
Doxorubicin Hydrochloride Liposome Injection, 50 mg/25 mL single-dose vials, is being recalled because of particulate matter identified as glass. 675 vials are affected.
TNVitamins and Doctor's Pride moringa green superfood capsules are being recalled because the product may be contaminated with Salmonella. 13,000 bottles are affected.
CORFLO Safety PEG Kits, catalog number 30-4320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 231 kits are affected.
Boston Scientific Clik X Anchors, model SC-4318, are being recalled because the sterile anchors may lack sterility assurance. 43 units are affected.
CGuard Prime Carotid Stent Systems, 135 cm with a 9 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
Halyard Pain Packs, kit code AMPK48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 120 kits affected.
Bicarby Dialysate across six model numbers is being recalled because luer-lock leaks during preparation present a potential slip and fall hazard from fluid on the floor.
TDC VELOCE 23G Two Dimensional Cutters are being recalled following an increase in complaints of a loose outer knife, including reports of it loosening during use.
Medartis APTUS 5.0 headed cannulated compression screws for bone fixation are being recalled because the cannulation of the screw is not centered. 13 units are affected.
MIC Safety PEG Kits, 24 Fr PULL, catalog number 7180-24, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 1,006 kits affected.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-4320, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 49 kits affected.
CORFLO Safety PEG Kits with ENFit Connector, catalog number 50-6312, are being recalled because they contain lidocaine hydrochloride injection subject to a supplier recall. 43 kits affected.
Boston Scientific is removing Orca Sterile, Single Use Air/Water and Suction Valves because of a higher than anticipated occurrence of the suction button sticking. 9,750 units affected.
Halyard Eye Bag Packs, kit code UIEB48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 60 kits affected.
Plum Duo Precision IV Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.
Park St. Deli Macaroni & Cheese, 20 oz, is being recalled because of undeclared soy lecithin. The action covers 58,405 cases.