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.
Queen Bee Gardens is recalling Honeymoons Ivory Chocolate Cashew candy because it may contain undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts, which can cause severe allergic reactions.
Queen Bee Gardens is recalling Huckleberry Truffles because they may contain undeclared tree nuts (pecans, almonds, coconut, macadamia, walnuts). Products were sold at retail locations in Colorado, New Mexico, Wyoming, and nationwide via internet.
Nephron Sterile Compounding Center has recalled 37,310 syringes of Lidocaine HCl Injection USP 1% nationwide due to lack of assurance of sterility. Affected lots expire between August and October 2022.
Aesculap Implant Systems is recalling the UR5 robotic arm component in its Aeos Digital Microscope System due to malfunction that prevents arm movement and requires system restart.
Chuckanut Bay Foods LLC is recalling cheesecake bite products with labels declaring sunflower lecithin when they actually contain soy lecithin. Soy is a major allergen not properly disclosed to consumers.
Queen Bee Gardens is recalling Bee Energy Bars due to undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Consumers with tree nut allergies should not consume this product.
Chuckanut Bay Foods is recalling Cheesecake Bites that contain undeclared soy lecithin, listed on the label as sunflower lecithin. Consumers with soy allergies may face serious risk.
Glenmark Pharmaceuticals is recalling Aspirin and Extended-Release Dipyridamole Capsules due to capsule breakage defects. Approximately 168,936 bottles were distributed nationwide.
Stryker Neurovascular is recalling 71 Trevo Trak 21 Microcatheter units because the product carton label is missing the required product drawing or illustration.
Randox Laboratories is recalling Soluble Transferrin Receptor reagent (TF10159) due to calibration curve defects causing inaccurate test results on Siemens Atellica CH analyzers.
Randox Laboratories is recalling Soluble Transferrin Receptors Calibrator kits used in lab analyzers. The calibrators can produce incorrect test results, with some values potentially underestimated by up to 30 percent.
Boston Scientific is recalling GreenLight HPSEA Laser Fibers due to an incompatibility with the fiber card that causes an error message and requires equipment replacement during procedures.
Launch Sequence Euphoria Capsules were marketed without FDA approval. Consumers should discontinue use immediately and contact the manufacturer.
Vi-Jon's hydrogen peroxide topical solution has been recalled due to cross-contamination with low levels of isopropyl alcohol. Multiple brands are affected nationwide in the USA and Canada.
LumiraDx is recalling SARS-CoV-2 antibody quality control products because modifications to the test were made outside the scope of FDA-approved authorization. The recall affects 99 units distributed across 13 U.S. states.
Xstrahl Limited is recalling specific lot codes of the X80 RADiant Photoelectric Therapy System due to a potential compatibility issue with replacement treatment applicators. Devices were distributed in Florida, California, and Kentucky.
Stryker is updating the Instructions for Use for the Triton Sponge System software (versions 4.6.5, 4.8.7, 4.9.6) to clarify proper handling technique for sponges and calibration placard. The FDA Class III recall affects 51 units distributed nationwide.
R & D Systems is replacing Instructions for Use (IFU) for Quantikine IVD Erythropoietin Human Serum Controls due to an incorrect CE marking designation that should not appear on the self-certified product.
Synapse Biomedical revised labeling for the NeuRx Diaphragm Pacing System to clarify that temperature range symbols indicate storage conditions, not transport or package conditions. The revision affects 71 units distributed in the United States.
Bryant Ranch Prepack has recalled Morphine Sulfate extended-release tablets due to a label mix-up where bottles may contain the wrong strength. Contact your pharmacy to verify your correct dose.
Natreve Vegan Protein Powder (Lot# 46359 and 46360) is recalled nationwide due to an undeclared milk allergen.
Morphine Sulfate extended-release tablets (30 mg) distributed in Alabama were recalled due to a critical label mix-up where bottles labeled as 60 mg contain 30 mg, and bottles labeled as 30 mg may contain 60 mg.
Arti King Refozado con Ortiga y Omega 3 Tablets are recalled nationwide because FDA testing found undeclared diclofenac and dexamethasone. The product was marketed without FDA approval and should not be used.
J & M Foods is recalling Favorite Day Lavender Shortbread Cookie Bites for undeclared egg and soy lecithin. Consumers with allergies to these ingredients should not consume the product.
Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.