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.
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.
Medline is recalling 980 units of medical convenience kits manufactured using SafeAir Smoke Evacuation Pencil components that Stryker previously recalled. The kits were distributed nationwide.
AvKARE is recalling 2,796 bottles of Cinacalcet Tablets (90 mg) nationwide due to manufacturing deviations resulting in N-Nitroso-Cinacalcet above acceptable intake limits.
Amerisource Health Services LLC recalls Duloxetine 20 mg delayed-release capsules due to the presence of N-nitroso-duloxetine impurity above acceptable limits. The affected bottles were distributed in Pennsylvania, Ohio, and Puerto Rico.
Siemens' Atellica CI Analyzer may display incorrect diluent volume levels, causing falsely elevated sodium, potassium, and chloride test results in 559 units distributed worldwide.
Aurobindo Pharma USA Inc is recalling Cinacalcet 60mg tablets nationwide due to N-nitroso Cinacalcet impurity exceeding FDA recommended interim limits.
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.
BD service credentials for BACTEC FX instruments were accessed by an unauthorized actor, creating risk of unauthorized system access until credentials are updated.
Sysco Classic Strawberry Drink Mix is being recalled due to metal fragments discovered during production. A damaged sifter in dextrose processing introduced the contamination into the product.
Epilog Laser Corp. is recalling Fusion Pro 24 Model 17000 laser systems because an incorrectly placed interlock device allows the front-loading door to open during operation, potentially exposing users to Class 4 laser radiation.
Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.
Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.
DYMA Brands is recalling Culinary Secrest Originals Vanilla Instant Pudding Mix because a damaged sifter introduced metal fragments into the product. Consumers should not consume the product.
Sysco Fruit Punch 24-ounce products are recalled due to metal fragments introduced during dextrose production. Consumers should not consume the affected product and contact their retailer for refund or replacement.
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.
BD confirmed that service credentials used by technical support teams were accessed by an unauthorized actor, creating a risk of unauthorized access to BD microbiology systems and associated data.
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.
Sysco Classic Banana Instant Pudding & Pie Filling Mix is recalled due to metal fragments introduced during dextrose processing. The product was distributed to 29 states.
Gordon CHOICE Fruit Punch Mix is being recalled due to metal fragments introduced during production. The affected product was distributed to 29 states.
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.
Olympus has removed high-level disinfection with Acecide-C as an approved reprocessing method for the GIF-1TH190 gastrointestinal videoscope. Approximately 1,770 units nationwide are affected.
Medline Industries is recalling 70 convenience kits containing SafeAir Smoke Evacuation Pencil components that were subsequently recalled by Stryker. The affected product types are General Endoscopy Pack and Endo Bladder Pack.
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.
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.
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.