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.
Philips CombiDiagnost R90 fluoroscopy systems may display a previous patient's images during radiography examination, potentially showing different image content, format, and size that could affect imaging accuracy.
The BEQ-HLS 7050 USA HLS Set Advanced 7.0 is recalled due to a compromised sterile barrier on its Emergency Priming Line component. This defect may cause inflammation, sepsis, or infection.
HydrALAZINE Hydrochloride Tablets Lot T04680 are recalled for out-of-specification impurities found during routine testing. No illnesses have been reported, but the product poses a remote risk of reversible effects.
Teva Pharmaceuticals is recalling Nortrel 7/7/7 oral contraceptive tablets due to a manufacturing defect: discolored blue tablets mixed with white inert tablets. This could cause confusion about which tablets to take in the triphasic regimen.
Amy's Kitchen is recalling Gluten Free Bean and Cheese Burritos (5.5 oz) due to the possible presence of plastic material in the product. The recall affects lot #30K0823 with best before date November 2025.
Quidel Corporation is recalling one lot of Sofia 2 Flu + SARS Antigen FIA diagnostic test kits due to incorrect expiration dates on packaging. Kits labeled to expire April 30 and May 31, 2025 actually expire September 12, 2024.
Stryker is recalling the Trevo Pro 18 Microcatheter because its instruction manual contains an intended use that the FDA has not evaluated. The recall affects 11 units distributed across the United States.
Teva Pharmaceuticals is recalling 12,916 cartons of Nortrel oral contraceptive tablets nationwide due to discolored inert remainder tablets that may cause confusion. Affected lot: #100042978, expiration 7/31/2024.
Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.
Walmart's EQUATE brand Hydration PF Lubricant Eye Drops are being recalled due to non-sterility. This FDA Class I recall affects 33,984 bottles distributed nationwide.
Cardinal Health is removing Monoject sterile syringes (Luer-Lock and Enteral with ENFit) from the market due to manufacturing and rebranding changes. Distribution affected US and Canada.
CVS Health Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) are being recalled nationwide due to non-sterility concerns. All lots of the product in single and twin pack bottles are affected.
Rite Aid is recalling Multi-Action Relief Drops nationwide due to non-sterility concerns. The FDA classified this as a Class I recall affecting 9,216 bottles.
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops are being recalled nationwide due to non-sterility. The recall affects all lots of the 0.5 FL OZ bottles distributed.
FDA recalls DRY EYE RELIEF eye drops nationwide due to non-sterility. The ophthalmic product distributed in 23,208 bottles affects all lots. Consumers should discontinue use immediately.
CVS Health brand Lubricating Eye Drops are being recalled due to non-sterility. The FDA Class I recall affects 45,408 bottles distributed nationwide.
The FDA recalled approximately 210,192 bottles of Leader brand Lubricant Eye Drops due to non-sterility that could allow contamination. All lots distributed nationwide are affected.
Rite Aid is recalling 7,296 bottles of lubricant eye drops nationwide due to non-sterility. The FDA has classified this as a Class I recall.
Detectors in Philips BrightView X gamma cameras may fall unexpectedly due to component failure, risking patient injury including fractures and lacerations.
Cardinal Health is removing all sizes of Monoject sterile syringes and enteral syringes from the market due to manufacturing and rebranding changes. Products were distributed in the US and Canada.
Cardinal Health Monoject enteral syringes in sizes 6mL to 60mL have compatibility issues with certain feeding pumps and may not properly connect. Cardinal Health recommends not using these syringes with enteral feeding pumps.
Rite Aid is recalling all lots of Lubricant Gel Drops due to non-sterility concerns. The product was distributed nationwide.
Cardinal Health is recalling Monoject sterile syringes due to manufacturing changes. The recall affects Luer-Lock and Enteral syringe models distributed in the US and Canada.
Kilitch Healthcare is recalling all lots of Velocity Pharma Lubricating Eye Drop due to non-sterility issues. The product was distributed nationwide; consumers should stop using it immediately.
Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) in Lot 230503 and 230701 have compatibility issues with certain feeding pumps and should not be used.