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.
Advagen Pharma is recalling Tramadol Hydrochloride Tablets after a pharmacy discovered baclofen tablets mixed in a bottle of tramadol. This nationwide recall affects 2,592 bottles.
Sacramento Cookie Factory is recalling Champagne Wafer - Raspberry Almond cookies due to undeclared milk allergen. Products were distributed across 14 U.S. states and pose a serious risk to consumers with milk allergies.
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg capsules due to elevated levels of N-nitroso-duloxetine, a manufacturing impurity above FDA limits. No illnesses have been reported.
GE Healthcare is recalling x-ray imaging systems because adhesive on critical bolts may not have been applied, potentially causing the detector or x-ray tube to fall. The recall affects 21 units worldwide.
Angiodynamics is recalling DURAFLOW 2 vascular access devices due to loose metal shavings that may travel through blood vessels, potentially requiring surgical removal.
Breckenridge Pharmaceutical recalls Duloxetine 20 mg capsules nationwide after detecting N-nitroso-duloxetine impurity above FDA-recommended limits in approximately 7,188 units from lot 220456, expiring February 2025.
Angiodynamics recalls DURAMAX STACKED TIP vascular access devices that may contain loosely affixed metal shavings. Metal shavings could embolize and potentially require surgical removal.
DB Yummers Sweet & Smokey Barbecue Sauce is recalled for lacking FDA-approved heat treatment. Bottles with best-by dates 05/18/25, 05/26/25, or 08/30/25 distributed in Kentucky and Ohio should not be consumed.
Breckenridge Pharmaceutical recalls Duloxetine 30mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA-recommended interim limits. The impurity was identified as a CGMP manufacturing deviation.
Belgian Yummies Homemade Ice Cream Birthday Cake Gelato is being recalled because it contains undeclared Yellow #5, an allergen not listed on the label. The recall affects products distributed in Florida.
Sacramento Cookie Factory is recalling California Wine Wafer - Mocha Chocolate products because they contain undeclared milk, a common allergen. The recall affects retail packages distributed across multiple U.S. states.
Sacramento Cookie Factory recalled Tea Wafers with Vanilla Almond flavor due to undeclared milk allergen. The product was distributed to multiple states and may pose a risk to consumers with milk allergies.
Sacramento Cookie Factory is recalling Java Wafer - Mocha Hazelnut cookies because they contain undeclared milk, a common allergen that poses a health risk to people with milk allergies.
GE Healthcare is recalling certain Allia and Discovery IGS x-ray systems due to potential adhesive failure that could cause the detector, elevator, or x-ray tube to fall. No injuries reported.
GE Healthcare is recalling Allia IGS 7 interventional x-ray systems due to potential adhesive failure on bolts securing the detector and x-ray tube, which could fall during use.
Detty Family Barbeque LTD is recalling DB Yummers Mildly Spicy Barbeque Sauce because it was manufactured without FDA-approved processing procedures. About 7,080 bottles were distributed in Kentucky and Ohio.
Baxter Healthcare is recalling one Spectrum IQ Infusion Pump that underwent improper testing before release. The device was distributed nationwide including in Massachusetts.
Randox Laboratories has recalled Clinical Chemistry Calibration Serum (Cal2351/Cal10388) due to negative bias in inorganic phosphate measurements on RX Series instruments. The issue could affect the accuracy of clinical chemistry test results.
Belgian Yummies is recalling 53 units of 5-liter strawberry gelato distributed in Florida due to undeclared Yellow #5 (Tartrazine) allergen. Consumers with Yellow #5 sensitivity should not consume this product.
SPINEART's PERLA TL 25D spinal fusion screws are being recalled due to difficulties with setscrew insertion inside the screw head. The setscrew may not be properly tightened or may be positioned incorrectly, potentially affecting spinal stability.
Detty Family Barbeque LTD is recalling DB Yummers Island Marinade Barbeque Sauce because it was not manufactured using an FDA-approved thermal processing procedure, creating potential for pathogenic contamination.
Angiodynamics DURAFLOW 2 hemodialysis kits may contain loosely affixed metal shavings that could enter the bloodstream. Metal fragments may require surgical removal if they embolize.
Tradewind Foods de Puerto Rico Inc. is recalling Goya Red Kidney Beans due to swollen and leaking cans discovered during an FDA inspection. The affected product was distributed in Puerto Rico and St. Croix.
Angiodynamics is recalling the BioFlo DuraMax 15.5F Single Valve Sheath VascPak Kit due to possible loose metal shavings. Metal shavings could enter the bloodstream and require surgical removal.
Kirkman 5-MTHF dietary supplement has a labeling error: the Supplement Facts incorrectly states 5000mcg Folic Acid per serving instead of 1000mcg. Lot# 477-0016, exp. 08/2025.