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.
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.
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.
Lupin Pharmaceuticals is recalling Ramipril 2.5 mg capsules after sourcing the active ingredient from an unapproved vendor. Approximately 112,770 bottles were distributed to wholesalers nationwide.
27,560 bevacizumab injection syringes distributed nationwide are being recalled due to failure to maintain sterility assurance. The affected syringes may not be sterile.
Abbott is recalling Abbott Navitor Transcatheter Aortic Heart Valves (27 mm) due to a manufacturing error causing leaflet deflection values outside specifications. This could affect valve durability and potentially cause valve failure.
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.
Safecor Health is recalling Docusate Sodium 250 mg softgels due to manufacturing defects where blister card-foils separated from the medication cavity, potentially compromising product integrity.
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.
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.
Major Pharmaceuticals is recalling Guaifenesin Dextromethorphan Syrup nationwide for specific lots that failed to meet impurity and degradation specifications. Consumers should contact their pharmacist if they possess affected lots.
Glenview Farms Spreadable Brie is being recalled due to potential Listeria monocytogenes contamination. 754 cases distributed across multiple states are affected.
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.
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.
Great Value Cheese Danish is being recalled due to plastic pieces found in the product. Consumers who purchased this item should discard it.
Major Pharmaceuticals has recalled Guaifenesin Dextromethorphan Syrup due to failed impurity and degradation specifications. Three lot numbers were distributed nationwide.
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.
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.
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.
Abbott Medical is recalling 10 units of the Abbott Navitor Titan transcatheter aortic heart valve due to a manufacturing error causing valve leaflets to fall outside specification. The defect could affect valve durability and cause valve failure.
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.
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.
Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Catalog 4706) due to manufacturing debris in the inner sheath that can block the needle and prevent injection solution flow.
Hobbs Medical recalls Posi-Stop Injection Needles because manufacturing debris in the needle can block injection solution flow.