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 recalls 1,025 bottles of fenugreek capsules containing pieces of a pen. The product was distributed to 284 retail stores across the United States.
Regal Foods, Inc. is recalling 674 lbs of Regal Italian Seasoning because rodent feces was found in oregano samples. The product was distributed in Georgia, Maryland, Pennsylvania, and Kentucky.
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.
SLR Food Distribution recalled dried longans distributed in seven states because they contain undeclared sulfites. Consumers with sulfite sensitivity may experience adverse reactions.
Wolf, Henke Sass is recalling Henke-Ject-2 single-use sterile syringes due to potential damage to the sterile barrier that could compromise product sterility. Approximately 216,000 units are affected across the US and Canada.
Vitality Works is recalling 1,025 bottles of Fenugreek Capsules (Lot 2023-06871) due to foreign pen pieces found in the product. The recall affects 284 retail stores across the United States.
Vitality Works is recalling 1,025 bottles of its 100-count vegetarian Fenugreek Capsules due to the presence of pen pieces in some units. No illnesses have been reported.
Cerebelly Inc is recalling Apple Kale Smart Bars due to visible surface mold contamination. The recall affects all 5-pack and 7-pack sizes distributed nationwide.
Dental planning software exoplan 3.1 contains a filtering error that may display all surgical guide options instead of only supported ones, potentially causing patient injury.
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 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.
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.
BD Pyxis MedBank MedPass Software may continue displaying dispensed medication doses as available, risking duplicate medication administration to patients.
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.
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 1,025 bottles of 100 vegetarian Fenugreek Capsules 90 count due to contamination with pieces of a pen. No illnesses have been reported.
Vitality Works is recalling 1,025 bottles of fenugreek capsules due to contamination with pieces of a pen. Consumers should stop using the product immediately.
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.
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.
3M is recalling 77,280 Attest biological indicators due to caps that may melt, deform, or crack during steam sterilization cycles, potentially compromising process validation.
3M is recalling 79,500 Attest Super Rapid Readout Biological Indicators because the cap may melt, deform, or crack during steam sterilization cycles, potentially compromising sterilization validation.
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 1,025 bottles of 100-count fenugreek capsules (600mg) due to contamination with pen pieces. The affected lot is 2023-06871, expiring July 2028.
Regal Foods is recalling Regal Fajita Seasoning distributed in Georgia, Maryland, Pennsylvania, and Kentucky because rodent feces was found in oregano samples.