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.
AvKARE is recalling 40 bottles of Sunitinib Malate Capsules due to a label mix-up. The affected lot was distributed nationwide in the United States.
Becton Dickinson recalled BD BBL Sensi Disc Ampicillin 2 μg test discs due to 65% potency loss over 18 months that may produce false resistant results in susceptibility testing.
GE Healthcare recalled 11 Optima 520 CT systems that produce progressively rotated scan images in helical, cine, and cardiac modes, potentially affecting diagnostic accuracy.
Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.
Service credentials for the BD EpiCenter Data Management System were accessed by an unauthorized actor. Until credentials are updated, system data and access controls are at risk.
BD recalled BACTEC 9120 Systems because technical support credentials were compromised by an unauthorized actor. Until credentials are updated, there is a risk of unauthorized access to the devices and associated data.
SYSCO Vanilla Instant (24oz pouches, Lot 268 ECA) is recalled because a damaged sifter introduced metal fragments into the product. Consumers should not consume affected products.
Service credentials for BD EpiCenter Data Management System were accessed by an unauthorized actor. This creates a risk of unauthorized access to the software and associated data until credentials are updated.
Certain GE Healthcare CT systems can produce progressively rotated images during helical and cardiac scans. Images may rotate up to 56 degrees, potentially affecting diagnosis if the rotation is not detected.
AvKARE is recalling 2,396 bottles of Cinacalcet Tablets 60 mg (Lot #44550) distributed nationwide due to CGMP deviations. The tablets contain N-Nitroso-Cinacalcet, a nitrosamine impurity, above acceptable intake limits.
Sysco Classic Vanilla Instant Pudding & Pie Filling Mix is recalled for metal fragments found in the product due to a damaged sifter used during dextrose production.
Siemens Atellica CH β2-Microglobulin reagent may produce falsely depressed test results for samples between 18-30 mg/L, potentially leading to missed or delayed kidney disease diagnoses. No illnesses have been reported.
Smith & Nephew is recalling BIORAPTOR Suture Anchors due to inadequate packaging design that fails to maintain sterile barriers, potentially contaminating the implant. No injuries or illnesses have been reported.
Rising Pharmaceuticals is recalling Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. The recall affects approximately 233,003 bottles.
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride Extended-Release Capsules (60 mg) due to presence of N-nitroso-Desmethyl-Diltiazem impurity exceeding FDA limits. Approximately 34,848 bottles nationwide are affected.
Medline is recalling surgical convenience kits that contain defective smoke evacuation pencils previously recalled by Stryker. The 478 affected units were distributed nationwide; healthcare facilities should discontinue use immediately and contact Medline for instructions.
Rising Pharma is recalling 122,925 bottles of Duloxetine 30 mg capsules nationwide due to a manufacturing deviation: the presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Certain GE Healthcare CT systems may display progressively rotated images, particularly during helical, cine, or cardiac scans. The rotation increases with each image, potentially reaching 56 degrees maximum.
Glenmark Pharmaceuticals is recalling 25,584 bottles of Diltiazem Hydrochloride Extended-Release Capsules 120 mg nationwide due to a manufacturing impurity above FDA-recommended limits. The affected medication was distributed throughout the United States.
GE Healthcare's Revolution ACE CT systems can produce progressively rotated images during certain scan modes. Maximum rotation reaches 56 degrees, potentially affecting diagnostic interpretation.
Ellington Farms Lemonade Drink Mix is being recalled due to metal fragments introduced during dextrose production. No illnesses have been reported. The product was distributed to 29 states.
GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. The issue affects 4 units worldwide and can cause rotations up to 56 degrees.
American Regent, Inc. is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination in vials. The intravenous drug distributed nationwide may contain particulate matter.
GE Healthcare's Revolution Maxima M and related CT systems may produce progressively rotated images during scans, potentially compromising diagnostic accuracy. Rotation increases with each image, reaching up to 56 degrees.
Becton Dickinson recalls the BD COR GX Instrument due to unauthorized access to product service credentials. Until credentials are updated, there is a risk of unauthorized device access and potential impact to data security.