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.
VistaPharm LLC is recalling Sucralfate Oral Suspension 1g/10mL due to out-of-specification assay results. The active ingredient concentration does not meet FDA specifications in approximately 14,400 affected bottles distributed nationwide.
Landauer is recalling QC (Cs-137) nanoDot D2DNS radiation dosimeters worldwide because some units may operate outside the specified accuracy range. The recall affects 10,741 units with all batch numbers.
Advance Medical Designs is recalling 117,875 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The recall affects kits distributed to the United States, Canada, United Kingdom, Panama, and Netherlands.
Baxter Healthcare is recalling the Welch Allyn Connex Spot Monitor due to improper placement of copper tape on the back of the liquid-crystal display. The device was distributed in California.
Twin Cities Co-Op Partners is recalling 720 containers of La Reyna Gluten Free Guacamole distributed to IA, MI, MN, and WI because the product was shipped at improper temperatures without quarantine.
Keystone Industries recalls Copaliner Cavity Varnish after discovering bottles of Copaliner Solvent were accidentally packaged in boxes labeled as varnish. The error affected 337 units distributed worldwide.
Landauer is recalling nanoDot D2DNS radiation monitoring dosimeters due to a potential defect in the OSL material. Affected devices may provide radiation exposure readings outside the specified +/-5.5% accuracy range.
Twin Cities Co-Op Partners is recalling 720 containers of La Reyna Salsa Roja due to temperature storage violations. The product was shipped to customers without proper quarantine after being stored outside required refrigeration specifications.
Twin Cities Co-Op Partners Inc. is recalling La Reyna Salsa Verde after the product was stored and shipped without maintaining proper temperature specifications.
Twin Cities Co-Op Partners is recalling 720 containers of La Reyna Queso Dip due to temperature control violations during shipment. The product was not quarantined after being received out of specification.
Keystone Industries is recalling 240 units of Henry Schein Hard Line Chairside Reline kits because the outer box is labeled as Soft Line, though the contents and instructions are correctly labeled.
Landauer is recalling 211,815 nanoDot D2DNS radiation dosimeters worldwide. Some units may be outside the specified ±5.5% accuracy range due to a defect in the optical material, potentially resulting in inaccurate radiation exposure measurements.
Twin Cities Co-Op Partners Inc. is recalling La Reyna Diablo Salsa because the product was received and shipped at improper temperatures. Refrigerated foods improperly stored may develop harmful bacteria.
Microbiologics Inc is recalling one lot of KWIK-STIK ANA QC sets missing one of three bacterial strains required for microbiological testing.
Advance Medical Designs is recalling ASG-001 ultrasound gel due to mislabeling of use instructions. The product was distributed in the US, Canada, UK, Panama, and Netherlands.
Advance Medical Designs is recalling 50-GEL20 ultrasound gel (13,750 units, lot 21043C2328) due to mislabeling with inappropriate use instructions. The product was distributed in the US, Canada, UK, Panama, and the Netherlands.
Advance Medical Designs is recalling procedural kits containing ultrasonic transmission gel because the product labeling does not accurately indicate appropriate use. The recall affects 460 units distributed to the US, Canada, UK, Panama, and Netherlands.
Marlex Pharmaceuticals recalls Digoxin Tablets nationwide due to a labeling error where bottles are mislabeled with incorrect dosages. Bottles labeled as 0.125mg contain 0.25mg and vice versa.
Aesculap trocars manufactured with shafts too long obstruct the visual field when used with neuroendoscopes in brain surgery. Affected units distributed in nine states should not be used.
Cook Vandergrift is recalling approximately 15,951 Cook Lead Clipper devices due to potential sterility compromise from packaging seal breaches. The surgical tool is used for cardiac lead retrieval procedures.
Zimmer, Inc. is recalling M/L Taper Hip Prosthesis implants where the outer package labeling and product etch do not match the actual implant size. This mislabeling could lead to implantation of the wrong-sized prosthesis.
PARAGON VISION SCIENCES is recalling 18,820 Fargo Ortho-K contact lenses because they were manufactured without required FDA approval. Patients should contact their eye care provider.
Capsaicin Cream 0.025% cartons labeled as pain relief cream may contain Sodium Fluoride 1.1% prescription dental toothpaste instead. Consumers should verify product contents before use.
Paragon Vision Sciences is recalling 83,542 ISee Ortho-K lenses because the manufactured product lacks FDA approval coverage. This is a Class II recall.
Philips 3D9-3v Transducer units may separate at the chassis bonding, risking electric shock and tissue damage if safety systems fail. Affected units distributed worldwide.