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-count Fenugreek Capsules due to contamination with pen pieces. Consumers who have purchased the affected lot should stop use and contact the manufacturer.
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.
Vitality Works is recalling Fenugreek Capsules due to contamination with pen fragments discovered during manufacturing. The recall affects approximately 1,025 bottles distributed across U.S. retailers.
Vitality Works, Inc is recalling 1,025 bottles of Fenugreek Capsules (90 count, 600mg) because they may contain pieces of a pen. Consumers should stop using the product and contact the manufacturer for a refund.
Vitality Works is recalling 1,025 bottles of 100 vegetarian Fenugreek Capsules due to contamination with pieces of a pen. Consumers should stop using the product immediately.
Vitality Works recalls 100 vegetarian Fenugreek Capsules due to foreign material contamination. Approximately 1,025 bottles containing pen pieces have been distributed to 284 retail locations nationwide.
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.
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.
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 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.
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.
Vitality Works is recalling fenugreek capsule bottles due to the presence of pen pieces in the product. The contamination affects 1,025 bottles distributed to retail customers across the United States.
Vitality Works is recalling fenugreek supplement capsules containing foreign material (pen pieces). The contamination poses a potential choking hazard.
Vitality Works is recalling Fenugreek Capsules (90-count, 600mg) due to contamination with pen fragments. The recalled product was distributed to 55 retail customers across the United States.
Vitality Works, Inc. is recalling its 100 vegetarian Fenugreek Capsules due to contamination with pieces of a pen. The affected lot (2023-06871) was distributed to 284 retail locations 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.
BD Pyxis MedBank MedPass Software may continue displaying dispensed medication doses as available, risking duplicate medication administration to patients.
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 Fenugreek Capsule supplements due to contamination with pen pieces. Affected products were distributed to 284 retail locations across the United States.
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.
Vitality Works is recalling its 100 vegetarian Fenugreek Capsules due to contamination with pen pieces. The product (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 pieces of a writing pen. The product was distributed to 55 retail customers across 284 stores in the United States.
Regal Foods is recalling Regal Herbs De Provence seasoning after rodent feces were found in oregano samples. The product was distributed in Georgia, Maryland, Pennsylvania, and Kentucky.
Vitality Works is recalling 1,025 bottles of fenugreek capsules due to contamination with pen pieces. No illnesses have been reported.