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.
Cerebelly Inc is recalling Cerebelly Smart Bar in Blueberry Banana flavor due to visible surface mold. The recall affects 154,554 cases distributed to all 50 U.S. states and territories.
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 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.
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.
Waldemar Link is recalling 8 units of the MobileLink Acetabular Cup System due to labeling with an incorrect offset specification. The mislabeling could affect proper surgical placement of this orthopedic implant.
Regal Foods is recalling Regal Fajita Seasoning distributed in Georgia, Maryland, Pennsylvania, and Kentucky because rodent feces was found in oregano samples.
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.
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.
Fresenius Kabi USA has recalled Ivenix Infusion System Large Volume Pump software versions 5.0.0 and 5.0.1 due to startup time delays that may exceed 6 minutes at flow rates between 50-200 ml/hr.
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 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.
Covidien LP is recalling Palindrome Chronic Catheter Kit devices where some catheters labeled as 23 cm implant length actually contain 28 cm devices. The mislabeling could affect proper catheter placement.
SLR Food Distribution recalled dried longans distributed in seven states because they contain undeclared sulfites. Consumers with sulfite sensitivity may experience adverse reactions.
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 Fenugreek Capsules (Lot 2023-06871) due to the presence of pen fragments. Consumers who have purchased this product should stop using it immediately.
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.
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 1,025 bottles of Fenugreek capsules due to contamination with pieces of a pen. The affected lot was distributed to retail locations across the United States.
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.
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.
Baxter Healthcare issued an urgent correction for the Epiphany Cardio Server E3 ECG Management System because the caliper tool may become non-responsive, temporarily preventing its use. Affects 89 units distributed across the US, Canada, and Bermuda.
Moreflavor, Inc. recalled 44 one-pound bags of CellarScience ascorbic acid (batch 56559) due to labeling error: bags labeled as ascorbic acid contain sodium percarbonate.
Pharma-Natural Inc. is recalling Pharma Natural Biotin 5000 mcg dietary supplement (Lot PN10686, Exp. Date 01/24) distributed in Puerto Rico because FDA testing found the biotin content was below the detection limit.
Vitality Works, Inc. is recalling 100 vegetarian fenugreek capsules (600mg) because some bottles contain pen fragments. Approximately 1,025 bottles were distributed to retail stores across the United States.
Vitality Works, Inc. is recalling its 100 Vegetarian Fenugreek Capsules due to contamination with pen pieces. The recall affects 1,025 bottles distributed to 284 retail stores across the United States.