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.
Sklar Instruments is recalling ECONO STERILE medical procedure kits (Model 96-4921A) due to packaging issues that may result in a breach of the sterile barrier. The kits should not be used.
Sklar Instruments is recalling ECONO STERILE nasal procedure kits due to packaging issues that may compromise sterility. The recall affects 175 units distributed nationwide.
QUIDEL ORTHO is recalling VITROS DGXN test slides because hemoglobin can interfere with digoxin measurements at lower-than-expected levels, potentially causing inaccurate test results.
Intuitive Surgical is recalling 56,580 units of the 8mm Cadiere Forceps (Model 471049) due to increased complaints of frayed or broken grip cables on the reusable surgical instrument.
Cardinal Health Presource surgical kits and dental packs are recalled due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units were distributed worldwide.
ConvaTec's Esteem Synergy Stomahesive Skin Barrier packages may contain pre-cut wafers of 28mm instead of the labeled 16mm or 35mm, potentially causing skin abrasion or bleeding during use.
Akron Pharma recalls 768 bottles of Acetaminophen Extra Strength 500 mg due to incorrect identification imprinted on the tablets nationwide.
Akron Pharma is recalling 1,232 bottles of Acetaminophen Extra Strength tablets due to incorrect imprinting on the tablets. The product identification may be wrong on the affected tablets.
Cook Biotech is recalling specific Cook Medical Biodesign Dural Graft devices due to incorrect expiration dates on two units and use of an incorrect Instructions for Use version.
Akron Pharma is recalling 14,825 bottles of Acetaminophen 325 mg tablets due to incorrect tablet imprinting affecting lots KDT0124004, KDT0124005, and KDT0124006 (expiring August 31, 2026). No illnesses have been reported.
Viatris is recalling Cardura XL (doxazosin) 4 mg extended-release tablets nationwide due to out-of-specification impurity results detected during stability testing.
Cook Biotech is recalling 6 hiatal hernia grafts (Lot #LB1579758) due to incorrect Instructions for Use and wrong expiration dates on two units.
IsoTis OrthoBiologics recalls OsteoSurge 100 Demineralized Bone Matrix Putty due to incorrect expiration dates on outer packaging. The outer box date does not match the correct date on the inner tray.
Eclectic Herb Vitamin Herb Blend dietary supplement is recalled because the Supplement Facts panel contains incorrect ingredient names and quantities. Consumers should check affected lot numbers.
DRG International is recalling the DRG:HYBRiD-XL Insulin device (Model HYE-5361) due to calibration failures and out-of-specification controls that may delay assay results.
Akron Pharma is recalling Diphenhydramine HCl 25 mg capsules nationwide because the capsules are imprinted with incorrect identification. Consumers should stop using the affected product.
Cook Medical is recalling 49 Biodesign Otologic Butterfly Graft surgical implants due to incorrect Instructions for Use version and incorrect expiration dates on product packaging. No illnesses or injuries have been reported.
Akron Pharma recalls 456 bottles of Diphenhydramine HCl 25 mg capsules due to incorrect ID imprinted on the capsules.
Akron Pharma is recalling Acetaminophen Regular Strength 325 mg tablets due to incorrect imprinting on the tablets. The recall involves approximately 6,429 bottles distributed nationwide.
Akron Pharma is recalling 324 bottles of Diphenhydramine HCl 50 mg capsules (lot KDC0224001B) due to incorrect identification imprinting on the capsules. The product was distributed nationwide in the United States.
Baker's Source Traditional Cornbread Mix is being recalled due to undeclared egg allergen. The 210,960-pound recalled quantity was distributed across eight states and poses a risk to consumers with egg allergies.
Endo USA recalls 8,029 cartons of Clonazepam 0.125 mg tablets nationwide due to incorrect carton labeling, although the tablets in the blister strips have the correct strength.
Grecian Delight and Sysco Classic tzatziki sauce may contain Salmonella. Consumers should discard the product or return it to their retailer.
The JMC5A Ni/TruAire-5 Oxygen Concentrator (Model O2C5L) is being recalled. The device may catch fire or melt during use, creating a risk of serious injury from fire and burns.
Endo USA, Inc. is recalling 22,513 cartons of clonazepam tablets due to incorrect strength labeling on some carton exteriors. The actual tablets inside have correct labeling.