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.
Evaric Pharmaceuticals is recalling Lisinopril 10 mg tablets after a metal fragment was found embedded in a tablet. The affected lot (241103) was distributed nationwide; contact your pharmacist if you have this medication.
Biomet's JuggerLoc/ToggleLoc 2.9mm Drill Guide may warp when removed from packaging, potentially extending surgical time or causing tissue damage requiring intervention.
Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Lot H11-23-057) because some units contain manufacturing debris that blocks the needle opening, preventing injection solutions from flowing properly.
CAIRE FreeStyle Comfort portable oxygen concentrators may fail to recharge their batteries, potentially leaving patients without access to supplemental oxygen. Twenty-three units have been recalled.
Hobbs Medical is recalling Posi-Stop 25-Gauge injection needles because some units contain manufacturing debris that blocks the needle's inner diameter, preventing injection solutions from flowing properly.
Maquet Cardiovascular is recalling approximately 33,823 units of the Acrobat-i Vacuum Stabilizer System due to manufacturing deviations that compromised the sterile barrier. Sterility cannot be assured for the 2-year shelf life.
Lupin Pharmaceuticals is recalling 357,414 bottles of Ramipril 10 mg capsules due to CGMP deviations where the active pharmaceutical ingredient was sourced from an unapproved vendor. The affected product was distributed to 30 wholesalers with potential nationwide distribution.
Six CAIRE FreeStyle Comfort oxygen concentrators may fail to recharge their batteries, potentially affecting portable use of these medical devices. Caire, Inc. is recalling affected units worldwide.
Hobbs Medical recalls Posi-Stop injection needles because manufacturing debris can block the needle, preventing injection solutions from flowing properly. Affected units were distributed across multiple US states and Canada.
Manufacturing defects in Siemens Atellica CH Cuvette Segments may cause inaccurate laboratory test results for seven analytes across 9,729 units.
Noven Pharmaceuticals Inc is recalling 685 boxes of XELSTRYM (dextroamphetamine) transdermal patches nationwide due to a defect in the adhesive delivery system. The product does not meet manufacturing specifications.
Caire recalls 739 FreeStyle Comfort portable oxygen concentrators that may fail to recharge their batteries. The devices were distributed in the US, Puerto Rico, Israel, and Peru.
Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates printed on product labels. Contact the manufacturer for corrected expiration information.
SAVENCIA CHEESE USA is recalling multiple Brie cheese brands sold at retailers including Aldi and Market Basket due to potential Listeria monocytogenes contamination. Products were distributed across 12 states with a best-by date of 12/24/2024.
Lupin Pharmaceuticals is recalling certain lots of Ramipril 5 mg capsules because the active ingredient was sourced from an unapproved vendor, raising concerns about product quality and safety.
Roche's cobas HCYS homocysteine test assay is recalled due to calibration defects that can produce inaccurate results. The assay can yield false positive or negative values.
Hobbs Medical is recalling Posi-Stop Injection Needles due to manufacturing debris inside the needle shaft that blocks medication flow. The affected lot was distributed across multiple US states and Canada.
Smiths Medical is recalling 156,400 CADD-Solis AC adapters due to damaged or broken input plugs that may expose metal contacts. The affected adapters could pose a risk of electrical shock or fire.
Novosource is recalling NovoHip Total Hip System units (lot CER0023) packaged in boxes labeled 32 long but containing 28 long components. If implanted, the wrong size may cause joint instability.
Three Abbott Navitor 29mm transcatheter aortic heart valves were recalled due to a manufacturing error that allowed valves with leaflet deflection outside specifications to be distributed. The defect could affect valve durability or cause valve failure.
Hobbs Medical is recalling Posi-Stop Injection Needles due to manufacturing debris that can block needle flow. Some units may contain debris in the inner sheath that prevents injection solutions from functioning properly.
The JM Smucker Company is recalling Great Value Cinnamon Rolls nationwide due to possible plastic pieces in the product. Consumers should not consume affected units.
La Bonne Vie Camembert 8oz cheese (UPC 820581678616, BBD 12/24/2024) is being recalled due to potential Listeria monocytogenes contamination. Approximately 70 cases were distributed across 12 U.S. states.
Caire Inc. is recalling 26 CAIRE FreeStyle Comfort portable oxygen concentrators due to potential battery recharge failure. Affected units identified by serial number may not charge properly.
Abbott Medical is recalling 8 units of the Navitor 27mm transcatheter aortic heart valve due to a manufacturing error in leaflet deflection that may affect valve durability and function.