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.
Certain GE HealthCare Vivid S60 ultrasound systems may not boot up in a timely fashion, potentially delaying device availability in time-critical emergency situations.
Medtronic Catalyft LS Expandable Interbody System spinal implants are being recalled due to out-of-specification device dimensions that may affect proper placement and spinal support.
Medtronic recalls 10 units of Catalyft LS spinal implants due to potential out-of-specification device geometries. The affected implants may not properly support or accommodate patient anatomy during lumbar fusion surgery.
CVS Pharmacy is recalling 16,200 cartons of Allergy Relief fexofenadine hydrochloride tablets nationwide due to failed impurities and degradation specifications. Stop using affected lot 2DV1925 and consult a pharmacist.
1st Phorm Level-1 protein supplement (Chocolate Marshmallow) is recalled because it may contain Staphylococcus aureus, a bacterium that can cause serious foodborne illness.
L. Perrigo is recalling 32,376 cartons of Good Sense Aller Ease antihistamine tablets nationwide due to failed quality specifications affecting impurities and degradation. Consult your healthcare provider if you have taken this product.
Medline is recalling Total Knee Theda surgical kits where the non-sterile PVP solution was mislabeled as sterile. Healthcare providers should immediately stop using the recalled kits and contact Medline.
Medline Industries is recalling 128 units of non-sterile PVP solution incorrectly labeled as sterile. Using a non-sterile product in sterile contexts could create infection risk.
Osteomed is recalling orthopedic screws with undersized heads that may pass through bone plates. Affected lot numbers were distributed nationwide in the US and Singapore.
GE Healthcare Vivid S70 ultrasound devices may experience delayed startup. This can reduce equipment availability during time-critical emergency situations.
EzriCare Artificial Tears eye drops are being recalled nationwide due to manufacturing facility contamination and CGMP deviations. The recall includes multiple lot numbers distributed nationwide.
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.
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.
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.
Medtronic recalls Catalyft LS spinal implants due to potential out-of-specification dimensions. The affected devices may not properly fit or function as intended during spine fusion surgery.
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.
GE Healthcare Vivid S60N ultrasound systems may fail to boot in a timely manner. This can delay device availability during time-critical emergency situations.
Vivus, Inc. is recalling Pancreaze delayed-release capsules nationwide due to failed stability specifications. The affected lot may not maintain product strength through the stated expiration date.
K.C. Pharmaceuticals is recalling 397,430 bottles of Equate and private-label dry eye relief drops nationwide due to Current Good Manufacturing Practice deficiencies related to fill line documentation.
L. Perrigo Company is recalling 1,920 cartons of Exchange Select Aller Ease (Fexofenadine Hydrochloride) 180 mg tablets nationwide due to failed impurity and degradation specifications.
Medline Industries recalled 15 units of non-sterile PVP solution in EAR CDS kits that were mislabeled as 'Sterile PVP SLN' instead of 'Non-Sterile PVP Solution, Sterile Packaging.' The mislabeling could result in inappropriate use in sterile medical applications.
Lupin Pharmaceuticals recalls Amlodipine Besylate 10 mg tablets (Lot A102887) after stability testing revealed the tablets failed potency specifications, containing less active ingredient than labeled. Patients should contact their pharmacist or doctor.
L. Perrigo Company recalls Kirkland Signature Aller Fex allergy tablets nationwide due to certain lots failing impurities and degradation quality specifications. Consumers with affected lots should contact their healthcare provider.
Target's store-brand fexofenadine allergy relief tablets are being recalled nationwide due to failed quality specifications for impurities and degradation. Consumers should stop using affected lots and contact Target or their healthcare provider.
L. Perrigo Company is recalling approximately 59,688 cartons of Fexofenadine Hydrochloride 180 mg allergy relief tablets nationwide because the product failed to meet FDA specifications for impurities and degradation.