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.
Vitality Works is recalling 1,025 bottles of 100 vegetarian Fenugreek Capsules (600mg) due to pen fragments discovered in some units. No illnesses have been reported.
Vitality Works is recalling 100 vegetarian Fenugreek Capsules (600mg) because bottles may contain pieces of a pen, posing a choking hazard.
Cerebelly Inc. has recalled Strawberry Beet flavor Smart Bars (5-pack and 7-pack) due to visible surface mold. Approximately 154,554 selling cartons were distributed across all U.S. states and territories.
Vitality Works recalls 1,025 bottles of fenugreek capsules due to foreign material contamination. The capsules may contain pen pieces and should not be consumed.
Vitality Works is recalling 1,025 bottles of fenugreek capsules due to contamination with pen pieces. No illnesses have been reported.
Vitality Works is recalling 1,025 bottles of Fenugreek Capsules due to contamination with pen pieces. The affected lot was distributed to retail customers across the United States.
Regal Foods, Inc. recalled Regal Taco Seasoning in multiple sizes due to rodent feces found in oregano samples. The product was distributed to Georgia, Maryland, Pennsylvania, and Kentucky.
Vitality Works is recalling 100 vegetarian Fenugreek Capsules due to contamination with pieces of a writing pen. The recall affects 1,025 bottles distributed to 284 retail locations in the United States.
Vitality Works Inc is recalling 100 Vegetarian Fenugreek Capsules due to pen fragments found in the product. The recall affects approximately 1,025 bottles distributed across 284 retail stores in the United States.
The Aquilex Fluid Control System (Models AQL-100PBS, AQL-100P) display may freeze at maximum volume (30,000 ml) during long procedures, causing inaccurate fluid monitoring and potential fluid overload.
Vitality Works is recalling 1,025 bottles of 100-count Fenugreek Capsules (600mg) due to contamination with pen pieces. The affected lot is 2023-06871, distributed to stores across the United States.
Vitality Works Inc. is recalling 1,025 bottles of 100 vegetarian Fenugreek Capsules due to contamination with pieces of a pen. Consumers should stop using the product and return or discard it.
IO Inspired Organics Organic Raw Walnuts recalled due to undeclared cashews. The product was distributed in six U.S. states; consumers with tree nut allergies should not consume.
Vitality Works is recalling fenugreek supplement capsules (Lot 2023-06871) due to contamination with pen fragments. About 1,025 bottles were distributed to 284 retail store locations across the United States.
A batch of NEURACEQ (florbetaben F-18), a radioactive diagnostic drug, was recalled by Sofie after failing sterility assurance testing. The affected batch was distributed to one facility in Virginia.
Vitality Works is recalling 1,025 bottles of 100 vegetarian Fenugreek Capsules due to contamination with pieces of a pen. The affected lot (2023-06871) was distributed to 55 retail customers across 284 stores in the United States.
Vitality Works is recalling 1,025 bottles of 100 vegetarian Fenugreek Capsules due to contamination with pen pieces. Consumers should discontinue use and contact the manufacturer for a replacement or refund.
Vitality Works, Inc is recalling 1,025 bottles of 100 vegetarian Fenugreek Capsules (600mg) due to contamination with pen pieces. The product was distributed to 284 retail stores across the United States.
Ambu Inc. is recalling the aView 2 Advance Monitor because multiple impacts can cause the device to short-circuit and potentially combust the lithium-ion battery, resulting in smoke and flames.
Mini Cigars from Ice Cream House are recalled due to potential Listeria monocytogenes contamination. The products were distributed in Ohio, New Jersey, and New York.
Vitality Works, Inc. is recalling 1,025 bottles of Fenugreek Capsules because pen pieces were found in the product. Consumers should stop use and contact the manufacturer for refund instructions.
Vitality Works is recalling approximately 1,025 bottles of 100 vegetarian Fenugreek Capsules because some bottles contain pieces of a pen. Consumers should stop using the product and dispose of it safely.
3M is recalling specific lots of Attest biological indicators used in steam sterilization monitoring. Certain lots have caps that may melt, deform, or crack at sterilization temperatures of 132°C and 135°C, potentially compromising sterilization process verification.
3M is recalling 172,464 units of Attest biological indicators used to validate steam sterilization because caps may melt, deform, or crack during sterilization at 132°C and 135°C.
J&T Health and Wellness LLC recalls the ProSun Luxura Vegaz Model 52X ultraviolet tanning device due to a potential safety circuit defect. A communication isolator may cause a disturbance that compromises the safety circuit.