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.
Nate's Fine Foods is recalling 52 totes of cooked linguine pasta, totaling 73,050 lbs, for potential contamination with Listeria monocytogenes.
Western United Fish Company is recalling 3,314.7 lbs of Kirkland Signature Ahi Tuna Wasabi Poke after its green onion supplier reported a Listeria monocytogenes positive test result.
Lee K of NY is recalling 43 containers of Pinocchio Catering Aged Kimchi Mackerel because the product contains undeclared milk and shrimp.
GenoGenix is recalling NAD+ for Injection at 100 mg/mL and 200 mg/mL from one lot for microbial contamination of sterile products, with elevated endotoxin levels.
New Age International is recalling 175 boxes of Signature brand Enoki Mushroom because the product may be contaminated with Listeria monocytogenes.
Nate's Fine Foods is recalling 56 cases of frozen cooked fettuccine pasta, totaling 1,680 lbs, for potential contamination with Listeria monocytogenes.
GenoGenix is recalling Tesamorelin for Injection, 15mg in a 10 mL multi-dose vial, from a single lot for lack of assurance of sterility.
GenoGenix is recalling Bacteriostatic Water for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Lysine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling preservative-free Ascorbic Acid (Vitamin C) for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Glutathione Magnesium for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Acuity Specialty Products is recalling AFCO isopropyl alcohol-based hand sanitizer because required receipt testing of incoming alcohol was not performed, so methanol risk could not be excluded.
GenoGenix is recalling Tirzepatide 60mg/10 mL for Injection from two lots for lack of assurance of sterility.
AvKARE is recalling 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets USP from one lot after the product failed content uniformity specifications.
GenoGenix is recalling L-Carnitine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Zinc Chloride for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Semaglutide with B12 for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Cerebrolysin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling B-Complex for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling B6 (Pyridoxine HCl) for Injections in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Taurine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
CorNeat Vision is recalling 180 EverPatch+ units after reviewed complaints identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
GenoGenix is recalling pH Buffered Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
Inpeco is recalling one FlexLab X system because the Sample Integrity Module's hemolysis, icterus and lipemia function has not been evaluated by the FDA.
GenoGenix is recalling B5 Dexpanthenol for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.