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.
Spanish Fly 22K capsules contain undeclared sildenafil and/or tadalafil and were marketed without FDA approval. The product poses serious health risks from these unapproved pharmaceutical ingredients.
Nineteen units of the Route 92 Medical 070 Reperfusion System may experience distal tip separation. Healthcare facilities should cease use of affected devices immediately.
FDA is recalling 5,299 bottles of Aruba Aloe Hand Sanitizer Gel nationwide due to methanol contamination in the ethanol ingredient. Consumers should stop using the product immediately.
The GOAT Sublingual Strip male enhancement product, distributed nationwide, was recalled for containing undeclared sildenafil and tadalafil. The product was marketed without FDA approval.
Route 92 Medical's Full Length 070 Access System (REF 7002) is recalled due to potential distal tip separation at the proximal marker band of the delivery catheters. This FDA Class I recall affects a device used in neurovasculature interventions distributed across the US and New Zealand.
Route 92 Medical recalls its Full Length 070 Reperfusion System due to potential distal tip separation at the proximal marker band, which could affect device delivery during interventional procedures.
Pyramids Wholesale Inc. is recalling all lots of GoHARD 25000 because it contains undeclared sildenafil and tadalafil. The product was marketed without FDA approval for these prescription-strength drugs.
EPI Health is recalling minolira extended-release tablets due to manufacturer discontinuation of quality control programs affecting product identity, strength, and purity. The recall covers 12,808 bottles distributed nationwide.
SeaSpine Orthopedics is recalling Mariner RDX pedicle screw heads because the thin lead-in thread poses a risk of cross-threading within the locking cap/screw head interface during surgery.
Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER52E hip prostheses due to excessive deburring on the acetabular shell. The defect may increase risk of hip dislocation in high-risk patients.
Alcon is recalling Custom Paks Surgical Procedure Packs containing Oasis 27Ga Chang Hydrodissection Cannulas due to complaints of particulates, residue, occlusions, and bent tips in sterile cannulas used in ophthalmic surgery.
SeaSpine's Mariner RDX MIS pedicle screw heads may have partial threading that causes cross-threading at the screw head interface during implant installation. Affected units distributed in CA, FL, CO, and TX.
Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER52E hip prostheses with excessive deburring on the acetabular shell edge, which could affect implant stability. Three units were distributed nationwide and internationally.
Howmedica is recalling hip replacement acetabular shells that may have excessive deburring, resulting in a smooth surface on the shell edge. The recall affects devices distributed nationwide and internationally.
Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER48D hip implants (Lot 16311453) due to excessive deburring on the acetabular shell edge, a manufacturing defect.
Leica is recalling 98 HistoCore PEGASUS automated tissue processors due to a protocol configuration error that can produce poorly processed or damaged biopsy specimens.
Parker Laboratories is recalling Redux Electrolyte Creme, a highly conductive medical electrolyte product, due to demonstrated low viscosity.
Certain Palindrome Precision HSI dialysis catheters do not have the heparin coating indicated on the label, which could reduce their protective benefits during dialysis procedures.
Howmedica Osteonics is recalling the TRIDENTII HEMI CLUSTER54E hip implant due to excessive deburring on the acetabular shell edge that may affect implant performance. The recall involves 225 units distributed nationwide and internationally.
Covidien is recalling 878 units of Palindrome Precision H Chronic Catheter Kits that may lack the heparin anticoagulant coating indicated on the label, potentially reducing clot prevention during hemodialysis.
Biomet is recalling the Vanguard Knee System AS Tibial Bearing (Model 189082) due to possible damage during manufacturing. Affected units were distributed worldwide including the United States.
EPI Health is recalling 5,664 bottles of minolira tablets because the manufacturer discontinued its quality assurance program. Affected lots include T2201700 and T2201701, distributed nationwide.
Cipla USA recalls Ipratropium Bromide and Albuterol Sulfate inhalation solution due to short fill in unit-dose vials. Some vials contain less medication than labeled, affecting dosage.
Howmedica Osteonics Corp. is recalling TRIDENTII HEMI CLUSTER44B hip implants due to excessive deburring on the acetabular shell edge. The recalled lot was distributed nationwide and internationally.
Home Style Foods is recalling Kowalski Simply Sides Jack's Potato Salad for containing undeclared egg, which poses a risk to consumers with egg allergies.