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.
Glenmark Pharmaceuticals is recalling 58,368 bottles of Atomoxetine Capsules 100 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. The recall affects bottles distributed nationwide.
RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations within dose planning functions affecting proton and light ion treatments in versions 4.5 through 2024B.
Hollister is recalling AnchorFast SlimFit oral endotracheal tube fasteners worldwide due to decreased skin barrier wear time that could lead to tube migration.
Augustine Temperature Management is recalling HotDog return electrode accessory connector cables (Model A136) used with warming blankets and mattresses. Users reported error M-0B-125 indicating improper neutral electrode contact.
THREE RIVERS brand Tutti-Frutti candy contains undeclared FD&C Yellow 5 and Yellow 6 dyes that were not listed on the label. Consumers allergic or sensitive to these colorants should not consume the product.
Under rare conditions, the Dexcom G6 receiver may fail to send high or low glucose alarms due to a software error, potentially delaying detection of dangerous blood sugar levels.
Hollister is recalling AnchorFast Oral Endotracheal Tube Fasteners due to reports of decreased skin barrier wear time, which could lead to tube migration. The recall affects approximately 366,324 units distributed in the US and Canada.
The Harvard Drug Group LLC is recalling Lorazepam 2mg tablets due to out-of-specification results in potency and impurity testing. Affected products were distributed nationwide.
Wabash Valley Farms and Rural King bacon flavored popcorn seasoning products are being recalled because soy allergen is not declared on the label, posing a risk to consumers with soy allergies.
Hollister is recalling AnchorFast Guard Select endotracheal tube fasteners due to decreased skin barrier wear time that could lead to tube migration.
Glenmark Pharmaceuticals is recalling Atomoxetine 25 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 175,920 bottles are affected.
Remel's blood agar culture media plates (lot 213971) may contain Listeria monocytogenes contamination visible on the blood side. The affected product was distributed nationwide; users should discontinue use immediately.
Remel, Inc recalls blood agar culture media used in diagnostic laboratories for potential Listeria monocytogenes contamination. The affected lot was distributed nationwide.
Glenmark Pharmaceuticals is recalling 119,040 bottles of Atomoxetine Capsules nationwide due to N-Nitroso Atomoxetine Impurity exceeding FDA recommended limits.
The FDA is recalling 94,349 cartons of Lorazepam 1mg tablets due to out-of-specification results for impurities and sub-potency discovered during routine stability testing. The affected product was distributed nationwide in the U.S. and Puerto Rico.
RayStation radiation therapy treatment planning software contains an inconsistency in how it handles density uncertainty during dose calculations for proton and light ion treatments, potentially affecting treatment planning accuracy.
RayStation treatment planning software versions 4.5-2024B contain a calculation error in density uncertainty functions affecting proton and light ion treatment plans. The error could lead to incorrect dose calculations.
RayStation radiation therapy treatment planning software contains an inconsistency in density uncertainty calculations that may affect dose accuracy for proton and light ion treatments. The issue affects systems using HU-to-mass density CT calibration curves from RayStation versions 4.5 through 2024B.
Glenmark Pharmaceuticals is recalling Atomoxetine Capsules, 60 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 53,952 bottles were distributed nationwide.
Augustine Temperature Management is recalling 4 units of the Hot Dog Patient Warming Mattress due to connector cable deflection that causes intermittent connection failures after approximately one year of use.
Augustine Surgical Inc. is recalling HotDog Return Electrode connector cables (Model A138) that display a 'Check Neutral Electrode Contact' error message. The recall affects 7 units distributed to Alabama, Texas, and Nevada.
Fagron Compounding Services is recalling 1,330 units of fentanyl Citrate IV bags (Lot C274-000040409) distributed in Pennsylvania due to lack of sterility assurance. The product may pose a contamination risk if administered.
Glenmark Pharmaceuticals is recalling Atomoxetine 25mg capsules nationwide due to manufacturing deviations resulting in N-Nitroso Atomoxetine impurity above FDA limits. Consumers should contact their healthcare provider or pharmacist.
KCI USA is recalling 3M Prevena Plus wound therapy systems due to complaints about malfunctioning leak alarms. The recall affects 135,268 units distributed worldwide.
Augustine Temperature Management is recalling Hot Dog Patient Warming Mattresses due to connector cable defects that may cause intermittent electrical connection after extended use, potentially affecting the device's heating function.