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.
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.
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.
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.
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.
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.
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.
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.
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 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 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 has recalled LA ORIGINAL NUT DIET MAX due to product mislabeling. The product contains Yellow Oleander instead of the labeled Nuez de la India.
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.
Power Snacks Honey Roasted Sunflower Kernels are being recalled nationwide due to potential undeclared soy and wheat allergens from mislabeling. Approximately 88,084 units are affected.
The break-away femoral nozzle in Stryker's ACM System may disassemble during use, potentially leaving fragments in the surgical site and causing device failure.
Encore Medical has recalled a hip stem orthopedic implant that was not sterilized before shipment. Non-sterile implants may cause infection if implanted, requiring treatment and potentially revision surgery.
TRP Natural Eyes Allergy Eyes Relief Sterile Eye Drops (NDC 17312-032-15, Lot IY001) are recalled due to lack of assurance of sterility. Approximately 8,747 units distributed to accounts in Rhode Island and Colorado.
Fox Confections is recalling F-Bombs Original Truffles due to undeclared Yellow #5 and Yellow #6 food dyes not listed on the label. Consumers with sensitivities to these dyes may be affected.
Fox Confections LLC recalls F-Bombs S'Mores Truffles due to undeclared FD&C Yellow #5 and Yellow #6 food dyes. The product may trigger reactions in individuals sensitive to these colorants.
Encore Medical is recalling 15 orthopedic implants (DJO Surgical Altivate Reverse) due to sterilization failure. If implanted, unsterilized components may cause infection requiring treatment, monitoring, or revision surgery.
Medline is recalling 324,451 sterile iris scissors because the tip protector may detach, exposing a sharp point that could puncture sterile packaging and compromise instrument sterility.
Mount Franklin Foods is recalling three varieties of honey roasted cashews nationwide due to undeclared soy and wheat allergens caused by mislabeling.
Mount Franklin Foods is recalling Circle K Honey Roasted Peanuts nationwide due to mislabeling that may result in undeclared soy and/or wheat allergens. Consumers with allergies to these substances should not consume this product.
TRP Natural Eyes Sterile Eye Ointment is recalled due to lack of assurance of sterility. The product was distributed to two accounts in Rhode Island and Colorado.
Somebody's Mother's White Chocolate (9.5 oz jars, Lot 060723) sold in Texas is being recalled because soy is not declared on the label. The undeclared allergen poses a risk to consumers with soy allergies.