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 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, 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, 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 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 is recalling 1,025 bottles of 100 vegetarian Fenugreek Capsules (600mg) due to the presence of pen pieces. No illnesses have been reported.
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.
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.
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 100 vegetarian Fenugreek Capsules due to the presence of pen fragments. The affected bottles were distributed to retail customers in the United States.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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 is recalling 6 control board spare parts for ventilators due to degrading capacitors that may leak electrolyte and cause electrical short circuits, potentially interrupting ventilation.
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.
Hamilton Medical is recalling 76 Hamilton-T1 ventilators because degrading capacitors on the control board can leak electrolyte, potentially causing interruption of 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 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.