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 600mg Fenugreek Capsules due to contamination with pen pieces. The affected lot is 2023-06871, expiring July 2028.
Vitality Works, Inc. is recalling 1,025 bottles of 100 Vegetarian Fenugreek Capsules due to contamination with pieces of a pen. The affected product was distributed to 284 retail stores across 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.
Vitality Works is recalling 1,025 bottles of 100 vegetarian Fenugreek Capsules (600mg) due to the presence of pen pieces. No illnesses have been reported.
Vitality Works, Inc is recalling 1,025 bottles of 100 Vegetarian Fenugreek Capsules (600mg) due to the presence of pen fragments. No illnesses or injuries have been reported.
Regal Foods is recalling 660 pounds of herbs and garlic products distributed to GA, MD, PA, and KY after rodent feces were found in oregano samples. Consumers should dispose of affected products marked with code 8400.
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 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 100 vegetarian Fenugreek Capsules due to the presence of pen fragments. The affected bottles were distributed to retail customers in the United States.
B.Braun NORM-JECT Luer Lock Solo 10ml sterile syringes are being recalled because the sterile blister packaging may be damaged, potentially compromising sterility. The recall affects 604,800 units distributed nationwide.
Regal Foods, Inc is recalling REGAL PASTA HERB 4oz packages due to rodent feces found in oregano samples. The product was distributed to GA, MD, PA, and KY.
B. Braun NORM-JECT Luer Solo 10 ml sterile syringes are recalled because blister packaging may be damaged, potentially compromising sterility. Approximately 534,000 units are affected; lot numbers 22M28C8 and 23A09C8 are included.
Regal Foods, Inc is recalling oregano leaves due to rodent feces found in product samples. The recall affects products distributed to Georgia, Maryland, Pennsylvania, and Kentucky.
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.
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.
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.
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.
Cerebelly Inc is recalling Cerebelly Smart Bars (Carrot Date flavor, 5-pack) due to visible mold on the product surface. The recall affects products distributed across all 50 U.S. states and territories.
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.
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.
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.
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-count Fenugreek Capsules (600mg) due to contamination with pieces of a pen. The recall affects 284 retail locations across the United States.
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.