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.
B. Braun Medical Inc. is recalling 79,880 bags of Sodium Chloride Injection due to potential leakage that could compromise sterility. No illnesses or injuries have been reported.
Sun Pharmaceutical is recalling Tiagabine Hydrochloride Tablets (2 mg) due to out-of-specification impurities detected during testing. The recall affects lot HAC3339A distributed nationwide.
Teva Pharmaceuticals is recalling 180 bottles of Sunitinib Malate Capsules due to moisture content exceeding approved specifications. The affected lot (100037220) expires 10/2024.
Baxter Healthcare recalls 1,010 Allen Advance Chest Support devices due to potential cracking where the support attaches to operating room table rails. No injuries reported.
Delsam Pharma's artificial tears eye drops are being recalled nationwide due to confirmed contamination linked to manufacturing facility defects. All affected lots were distributed via two distributors.
Stryker Power-PRO 2 ambulance cots may develop bent base leg assemblies, risking cot tips, unstable motion, and operational difficulties. Approximately 1,980 units were recalled.
Medtronic recalls 25 units of Catalyft LS spinal implants (lot numbers NM21J039, NM21M026) due to out-of-specification device dimensions that may affect surgical fit and function.
K.C. Pharmaceuticals is recalling 341,568 bottles of Sunmark and generic tetrahydrozoline eye drops due to manufacturing practice deficiencies. The recall affects multiple brands distributed nationwide.
Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to out-of-specification conductivity, osmolality, and pH. The diluent may produce inaccurate blood cell test results.
Accord Healthcare is recalling Atropine Sulfate Injection due to the presence of particulate matter identified as fiber. Two lots totaling 2,348 vials have been distributed nationwide.
GE Healthcare Vivid S60N ultrasound systems may fail to boot in a timely manner. This can delay device availability during time-critical emergency situations.
GE Healthcare Vivid S70 ultrasound devices may experience delayed startup. This can reduce equipment availability during time-critical emergency situations.
Oregon Potato Company is recalling frozen berry products distributed nationwide under multiple brand names due to potential Hepatitis A contamination. Consumers who have purchased these products should not consume them.
Medline Industries is recalling 1,500 units of non-sterile PVP solution mislabeled as sterile in ophthalmic and eye surgical kits. Users may unknowingly apply non-sterile solution in eye procedures, risking infection.
Medtronic is recalling Catalyft LS spinal implants due to potential out-of-specification device geometries that may not properly accommodate patient anatomy.
L. Perrigo Company is recalling Berkley Jensen Allergy Relief tablets due to failed product quality specifications involving impurities and degradation. Consumers should verify their lot numbers and expiration dates.
Accord Healthcare is recalling Bivalirudin for Injection lot M2212070 due to the presence of fiber particles. Bivalirudin is an injectable blood thinner used in cardiac procedures.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 20 due to measurement bias affecting laboratory results for immunoglobulin and complement protein testing. Falsely elevated or reduced values could be reported.
Medtronic is recalling 11 units of its Catalyft LS Expandable Interbody System spinal implants due to potential out-of-specification dimensions that could affect surgical fit and stability.
Medline is recalling 4,500 surgical kits because the non-sterile PVP solution inside was mislabeled as sterile. Using the mislabeled product in sterile surgical procedures could introduce non-sterile materials into surgical fields.
Medline Industries is recalling batches of non-sterile PVP solution that were incorrectly labeled as sterile, creating risk of inadvertent use in sterile medical settings.
L. Perrigo's Allergy Relief 180 mg tablets are being recalled due to failed impurity and degradation specifications. The recall affects 32,904 cartons distributed nationwide.
Careone Allergy Relief fexofenadine hydrochloride 180mg tablets are recalled nationwide for failing impurity and degradation specifications. Lot 2JE2185 with expiration date 01/24 is affected.
Abiomed 14Fr Low Profile Introducer Sets are being recalled due to silicone oil contamination that may cause sidearm detachment during use. One detachment has been documented; no injuries have been reported.
Tampico brand Mango Punch (1 gallon) is recalled because it contains undeclared Yellow 5, a food dye that can cause reactions in people with tartrazine sensitivity.