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.
Homeocare Laboratories is recalling Babelyn Diarrhea Drops due to manufacturing control (cGMP) deviations. The voluntary recall affects 5,957 bottles distributed nationwide.
Randox Laboratories has recalled a quality control product used in laboratory testing because control values are running outside their target ranges. This can delay when test results are reported.
Homeocare Laboratories is recalling SnoreStop Naso Spray Bulk due to current Good Manufacturing Practice (cGMP) deviations. This voluntary recall affects product distributed nationwide in 55-gallon drums.
RelieVR VR behavioral therapy device software may malfunction, preventing progression to the next treatment session. No injuries have been reported.
The EliA GliadinDP IgG test well produces higher reported results when used on the Phadia 2500EE instrument compared to the Phadia 250, potentially causing diagnostic inaccuracies. Phadia US Inc is recalling 568 units distributed in California, New Jersey, and Michigan.
Anatox Inc has recalled Sonne's Detoxificant #7 due to elevated lead levels. The voluntary recall affects approximately 2,870 bottles distributed in multiple states.
Bebelyn Colic Drops homeopathic remedy is recalled due to Current Good Manufacturing Practice deviations. Approximately 5,956 bottles were distributed nationwide.
Homeocare Laboratories recalls Kanjo Homeopathic Pain Relief Cream due to manufacturing process deviations. The recall affects 921 bottles distributed nationwide.
StellaLife VEGA Oral Care Gel is being recalled nationwide due to manufacturing practice deviations. Approximately 38,105 tubes are affected by this voluntary recall.
StellaLife VEGA Oral Care Spray is being recalled for manufacturing deviations. The product was distributed nationwide; consumers should discontinue use of affected lots.
Philips is recalling DigitalDiagnost C90 diagnostic imaging systems due to a software login issue that may prevent users from logging in to the device. The recall affects 58 units distributed across the U.S. and internationally.
Phadia US Inc is recalling the Phadia 2500EE diagnostic instrument. The device produces higher reported results compared to the baseline Phadia 250 instrument.
StellaLife VEGA Oral Care Rinse (Coconut, Lot #2396) was recalled due to manufacturing process deviations. About 16,587 bottles were distributed nationwide.
Randox Laboratories is recalling Immunoassay Premium Control Tri Level quality control kits due to out-of-range values that caused delays in test result reporting. The affected lot was distributed to five states and Puerto Rico.
The FDA is recalling StellaLife VEGA Oral Care Rinse nationwide due to current Good Manufacturing Practice (cGMP) deviations. The manufacturer voluntarily initiated the recall.
Great Lakes Coca-Cola Distribution LLC is recalling Fanta Orange 12-pack cases distributed in California because packages labeled zero sugar actually contain full sugar. Consumers relying on accurate labeling for dietary reasons should not consume affected products.
Certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may fail to deliver adequate energy during high-voltage therapy due to a specific feedthrough defect. Medtronic is recalling 1,132 affected units.
Medtronic is recalling 664 implantable cardioverter defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect could prevent critical defibrillation therapy when needed.
Wegmans Italian Classics Diavolo Pasta Sauce 24 OZ is being recalled due to undeclared fish content. Fish allergies could pose serious health risks to consumers who consume the product unknowingly.
Medtronic's ICD COBALT defibrillators may fail to deliver critical therapy due to a manufacturing defect in a power delivery component. Patients should contact their physician to determine if affected.
Medtronic's MIRRO MRI implantable cardioverter defibrillators with a specific glassed feedthrough may rarely fail to deliver adequate energy output during high-voltage therapy, affecting approximately 2,831 units distributed worldwide.
Medtronic implantable cardioverter defibrillators (CRT-D) may deliver reduced or no energy during high-voltage therapy due to manufacturing defect in the feedthrough component. FDA Class I recall affects 182 units.
Medtronic implantable cardioverter defibrillators may fail to deliver critical therapy due to a feedthrough defect. The defect can cause reduced or absent energy output during high-voltage therapy in 8,602 affected units distributed worldwide.
Medtronic's ICD-VR DVMB2D4 implantable defibrillators may fail to deliver electrical therapy due to a defect in the feedthrough component. The recall affects 6,477 units distributed worldwide.
Medtronic ICDs and CRT-Ds with a specific feedthrough defect may produce reduced or no energy output during high-voltage therapy. The recall involves approximately 4,546 units distributed nationwide and worldwide.