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 Fenugreek Capsules due to contamination with pieces of a pen. Consumers should stop using the product and return it to the retailer.
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.
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.
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 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.
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 (90 count, 600mg) because they may contain pieces of a pen. Consumers should stop using the product and contact the manufacturer for a refund.
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.
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 Fenugreek Capsules (Lot 2023-06871) due to the presence of pen fragments. Consumers who have purchased this product should stop using it immediately.
RB Health (US) is recalling Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%) due to an incorrect label on the back of the packaging. The recall affects 36,426 individual units distributed nationwide.
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.
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 is recalling 1,025 bottles of Fenugreek Capsules (Lot 2023-06871) due to contamination with pen pieces. The product was distributed to 284 retail stores across the United States.
Tolmar, Inc. is recalling Eligard (leuprolide acetate) 7.5 mg monthly injectable suspension nationwide because the constituted product contains higher than expected levels of the active ingredient. The affected lot is 13635A1 with expiration date July 31, 2024.
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.
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.
Ozona Organics LLC is recalling Ozona Organics and Go Healthy Liquid Probiotics nationwide due to high water activity in the formula that could allow microbial growth. No illnesses have been reported.
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.
Hamilton Medical is recalling 164 Hamilton-C1 portable ventilators due to degrading capacitors that may leak electrolyte, causing electrical short circuits that could interrupt ventilation.
OBC GROUP CORP is recalling NUT DIET MAX dietary supplement capsules due to substitution with toxic Yellow Oleander instead of the labeled ingredient Nuez de la India.
Hamilton Medical is recalling ventilator spare parts (ESM Shielding Set) due to potentially degrading capacitors on the control board. These capacitors may leak electrolyte and cause a short circuit, interrupting ventilation.
Hamilton Medical recalls 1,216 Hamilton-T1 ventilators due to degrading capacitors on the control board that may leak electrolyte and interrupt ventilation. The recall affects units distributed nationwide in the US and Puerto Rico.
Hamilton Medical is recalling 12 intensive care ventilators (model Hamilton-MR1) due to degrading capacitors that may leak electrolyte, potentially causing ventilation interruption. The recall affects specific serial numbers across the US and Puerto Rico.
Novartis is recalling SANDIMMUNE Oral Solution bottles nationwide because they were found to contain crystals. Patients should contact their pharmacy or prescriber about affected bottles.