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.
QC Quality Choice Menthol Cough Suppressant Oral Anesthetic Cough Drops, menthol flavour, 30-count bags, are being recalled following FDA observations at the manufacturing facility.
Nephron is recalling one lot of Albuterol Sulfate Inhalation Solution 0.5% unit-dose vials because of an illegible label. The action covers 146,280 vials.
QC Quality Choice sugar free Menthol Cough Suppressant Oral Anesthetic Cough Drops, honey lemon, 25-count bags, are being recalled following FDA observations at the manufacturing facility.
Discount Drug Mart Food Market Cough Drops, honey lemon, 30-count bags, are being recalled following FDA observations at the manufacturing facility.
Apotek is recalling one lot of Desmopressin Nasal Spray, USP because of a defect in a batch of bottle caps involving dislodged or missing cap liners.
Avantor Performance Materials is recalling one lot of bulk Magnesium Chloride 6-Hydrate active pharmaceutical ingredient because the material is subpotent. 36 bottles are affected.
Caring Mill Menthol Cough Suppressant Oral Anesthetic Cough Drops, cherry, 90-count bags, are being recalled following FDA observations at the manufacturing facility.
QC Quality Choice Pectin Oral Demulcent Throat Soothing Drops, creamy strawberry flavour, 30-count bags, are being recalled following FDA observations at the manufacturing facility.
Skin Rehab Calming Skin Gel Hydrocortisone Balm, hydrocortisone 1%, is being recalled because the product is subpotent. The action covers 2,895 bottles.
Taro is recalling one lot of Fluocinonide 0.05% Cream in 30 g tubes after stability testing returned viscosity results above the specification limit. 41,712 tubes are affected.
Remedy Gel, hydrocortisone 1%, distributed by glo Skin Beauty is being recalled because the product is subpotent. The action covers 1,060 bottles.
Taro is recalling one lot of Fluocinonide 0.05% Cream in 60 g tubes after stability testing returned viscosity results above the specification limit. 2,640 tubes are affected.
MGC Health sugar free Menthol Cough Suppressant Oral Anesthetic Cough Drops, honey lemon, 25-count bags, are being recalled following FDA observations at the manufacturing facility.
QC Quality Choice Menthol Cough Suppressant Oral Anesthetic Cough Drops, honey lemon flavour, 30-count bags, are being recalled following FDA observations at the manufacturing facility.
Bee Well Raw & Unfiltered Wildflower Honey is being recalled after FDA sample results were positive for a high C4 sugar content.
Exchange Select Menthol Cough Suppressant Oral Anesthetic Cough Drops, honey lemon, 30-count bags, are being recalled following FDA observations at the manufacturing facility.
QC Quality Choice sugar free Menthol Cough Suppressant Oral Anesthetic Cough Drops, black cherry, 25-count bags, are being recalled following FDA observations at the manufacturing facility.
LinkBio is recalling the CORE Workstation, a component of the CORE Shoulder System, because it may display an incorrect planning date on the Start Case menu screen.
QC Quality Choice Menthol Cough Suppressant Oral Anesthetic Cough Drops, vanilla honey flavour, 30-count bags, are being recalled following FDA observations at the manufacturing facility.
MGC Health Menthol Cough Suppressant Oral Anesthetic Cough Drops, honey lemon, 30-count bags, are being recalled following FDA observations at the manufacturing facility.
Medline is recalling Robotic Pack and Uro/Gen Robotic Pack convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect during use.
Medline is recalling TAVR PACK convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind during use and disconnect from the manifold. 108 units are affected.
Medline is recalling CVOR Angiography Pack-LF convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect during use. 3,120 kits are affected.
Fresh whole cantaloupes sold under the Ayco brand are being recalled over potential Salmonella contamination. The action covers 8,302 cartons distributed to four states.
Medline is recalling cath lab and angiography procedure packs containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect. 17,902 kits are affected.