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.
XTANT Medical is recalling 2 units of Xpress Pedicle Screw System from one lot mislabeled with an incorrect part number that identifies them as shorter than their actual physical length.
Cook Medical has recalled 916 units of Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets worldwide because the labels show expiration dates that exceed the true shelf life of the devices.
Fagron Compounding Services is recalling Vancomycin HCI injections nationwide due to lack of sterility assurance and potential detachment of a break-off-part from the administration port. Affected healthcare facilities should refer to FDA guidance.
The FDA is recalling Vancomycin HCI injectable solution (34,260 bags) distributed nationwide due to lack of sterility assurance and risk of a blue break-off-part detaching from the administration port.
Fresenius Kabi recalled specific batches of 0.9% sodium chloride injection because sterility cannot be assured. The affected batches were distributed throughout the United States, Alaska, and Puerto Rico.
Viatris Inc. recalls Xanax XR (alprazolam) 3 mg extended-release tablets due to failed dissolution specifications. Affected lot 8177156 (exp. 02/28/2027) was distributed nationwide.
Fagron Compounding Services is recalling norepinephrine bitartrate injection nationwide due to lack of sterility assurance and a blue break-off part that could detach from the administration port.
Fagron Compounding Services is recalling 5,140 bags of norepinephrine injectable nationwide due to lack of sterility assurance and a potentially detachable component in the administration port. The affected lots expire between April and July 2026.
Fresenius Kabi USA is recalling a batch of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The product was distributed nationwide, in Alaska, and Puerto Rico.
Fagron Compounding Services is recalling Vancomycin HCL injectable solutions due to lack of sterility assurance and risk that a blue break-off part could detach from the administration port.
Spacelabs Multi-parameter Command Module Model 91496 may provide inaccurate cardiac measurements in Auto mode due to a circuit board defect, potentially delaying diagnosis and increasing risk of fluid overload.
Cook Incorporated is recalling 95 Cook Staged Extubation Sets worldwide because the devices are labeled with expiration dates that exceed their actual shelf life. Using an expired device could compromise its sterility and safety.
Cook Incorporated is recalling certain COOK Spectrum Central Venous Trays that are labeled with expiration dates exceeding their actual shelf life, creating risks of compromised sterility and device degradation.
Beckman Coulter is recalling MicroScan Neg MIC 3J diagnostic panels due to manufacturing errors affecting test accuracy. One well per panel is missing a required drug while others contain double the intended amount of antibiotics.
Tornier HRS Max orthopedic implant parts were mislabeled as compatible with the HRS Max system, but are actually compatible only with the older HRS system and will not work with HRS Max components.
ARTIS pheno and ARTIS Icono X-ray systems may display dramatically higher radiation dose readings than actually applied during patient examinations. The actual dose remains compliant with regulations, though the display error could lead clinicians to question equipment accuracy.
Artificial Tears glycerin eye drops made by Preferred Pharmaceuticals are being recalled due to lack of sterility assurance. The 0.5 oz bottles were distributed nationwide.
Fresenius Kabi recalled specific batches of 0.9% Sodium Chloride Injection due to lack of sterility assurance. Affected batches were distributed nationwide, Alaska, and Puerto Rico.
DADI NONGFU Dried Salt Chilli Vegetables are recalled for containing cyclamates, a sweetener banned in the United States. The affected product was distributed in New York, Pennsylvania, and Florida.
Olive skewers from MEI YU CHENG DA TRADING INC contain cyclamates, a banned sweetener. The FDA is recalling 29 cases distributed to NY, PA, and FL.
Teva Pharmaceuticals recalls 124,054 cartons of prescription clonidine transdermal patches due to manufacturing deviations involving an unapproved raw material.
Cook Incorporated is recalling COOK MEDICAL Approach CTO-12 Micro Wire Guides due to incorrect expiration dating on device labels. The labeled expiration dates exceed the true shelf life.
Cook Incorporated is recalling 49 units of its Strange Bile Duct Stone Exploration Set due to incorrect expiration dates on product labels that exceed the true shelf life.
Imu-Tek Animal Health has recalled Imu-Tek Colostrum-5 Powder because the product may be under-processed. The recalled lot was distributed across 29 states.
Lone Star Dairy Products LLC is recalling Spray Dried Dairy Powder in 25 kg bags and 1 metric ton totes due to Salmonella identification in finished product testing.