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.
Aurobindo Pharma USA is recalling Cinacalcet 30mg tablets nationwide due to N-nitroso Cinacalcet impurity above FDA limits. Patients should contact their healthcare provider about their medication.
Rising Pharma recalls Duloxetine Delayed-Release Capsules 20 mg nationwide due to N-nitroso-duloxetine impurity exceeding recommended interim limits, affecting 209,376 bottles.
The Ziehm Solo FD interventional fluoroscopic x-ray system's hand switch may fail when exposed to mechanical stress, potentially causing unintended radiation. Twenty-five units are affected in the U.S. and Puerto Rico.
GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. Images can rotate up to 56 degrees, potentially requiring patient rescans.
The Ziehm Vision RFD 3D hand switch can fail when exposed to mechanical stress like dropping, potentially initiating unintended radiation from the x-ray system.
Apple Wedge Cinnamon Apple Cider is being recalled due to elevated patulin contamination detected in testing. Affected products were distributed to Georgia, North Carolina, South Carolina, and Florida.
Dyma Brands recalls Thirster Low Cal Fruit due to metal fragments in the product from a damaged sifter during dextrose production. The affected pouches were distributed across 29 states.
GE Healthcare CT systems have a technical issue causing progressive image rotation during helical and cardiac scans. No injuries reported, but unnoticed rotation could affect diagnosis or require rescans.
BD EpiCenter software service credentials were accessed by an unauthorized actor. Until credentials are updated, there is risk of unauthorized access to the software and associated data.
MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.
AROMA VITA Hot Cocoa Mix is being recalled due to metal fragments in the product caused by a damaged sifter used during dextrose production.
Orthoscan Inc. is recalling 22 Ziehm Vision FD fluoroscopic x-ray systems. The hand switch may fail when dropped or impacted, potentially initiating unintended radiation exposure.
Gordon CHOICE Lemonade Beverage Mix is being recalled for metal fragment contamination in the product. Consumers should stop using affected packages and contact the manufacturer.
Certain GE Healthcare CT systems may produce progressively rotated images during diagnostic scans. If undetected and a rescan is needed, the same rotation recurs.
GE Healthcare CT systems may display progressively rotated images, particularly in helical, cine, and cardiac scans. Rotations up to 56 degrees may affect image interpretation and could necessitate additional patient scanning.
Medline is recalling multiple lots of its convenience kits because they contain a component (SafeAir Smoke Evacuation Pencil) that was previously recalled by Stryker. The affected kits are distributed nationwide.
Glenmark Pharmaceuticals recalls Diltiazem Hydrochloride extended-release capsules due to presence of N-nitroso-desmethyl-diltiazem impurity above FDA recommended limits. The recall affects 12,864 bottles distributed nationwide.
Orthoscan's Ziehm Vision RFD fluoroscopic x-ray systems may have wired hand switches that fail under mechanical stress, potentially causing unintended radiation. The manufacturer is recalling affected units in the U.S. and Puerto Rico.
Medline is recalling medical convenience kits (CLEAN CLOSING PACK and CLEAN CLOSURE PACK GREEN) distributed nationwide because they contain a SafeAir Smoke Evacuation Pencil component that was recalled by Stryker.
DYMA Brands is recalling Sysco Low Cal Lemonade (8.6 oz pouches) due to metal fragments introduced during production. The product was distributed across 29 states.
AvKARE is recalling Sunitinib Malate 25 mg capsules nationwide due to a label mix-up in lot 100049501. The FDA has classified this as a Class II recall.
Medline is recalling L&D convenience kits distributed nationwide because they were manufactured with smoke evacuation pencils that Stryker subsequently recalled. The affected kits contain components from lot 23HMI048.
Lannett Company is recalling 1,608 bottles of Lisdexamfetamine Dimesylate 10 mg capsules nationwide due to failed content uniformity. The active ingredient may be unevenly distributed in some capsules.
Medline is recalling 88 units of tracheostomy convenience kits containing a defective smoke evacuation pencil component that was previously recalled by Stryker. Products were distributed nationwide.
Becton Dickinson recalled the BACTEC 9240 System after unauthorized actors accessed product service credentials. Until credentials are updated, there is risk of unauthorized access that may compromise system security and data integrity.