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.
Glenmark Pharmaceuticals is recalling 120,000 bottles of Atomoxetine 10 mg capsules nationwide due to N-nitroso Atomoxetine impurity exceeding FDA recommended limits. Multiple lot numbers are affected with expiration dates through July 2026.
AKT Trading Inc. is recalling Menma Ajitsuke prepared bamboo shoots because the packaging is missing a "Keep Refrigerated" statement. The product requires refrigeration and improper storage could allow bacterial growth.
Wismettac Asian Foods is recalling Shirakiku brand Curvee Puffs Corn Puff Snack because the product contains undeclared milk allergen. The affected product was distributed nationwide to approximately 471 consignees.
Olympus Single Use Guide Sheath Kits (models K-201 through K-204) are recalled because the radiopaque tip of the guide sheath may detach and fall into the patient during respiratory procedures.
The Smart Drive MX2+ SpeedControl Dial remote is being recalled due to a faulty circuit board that could cause loss of control of the wheelchair power assist, potentially resulting in injury.
Frito-Lay is recalling Pearl Milling Company Original Pancake & Waffle Mix due to undeclared milk allergen. The product may cause allergic reactions in consumers with milk allergies.
Fresh Direct Dark Chocolate Pretzels 7oz bags are recalled due to undeclared milk allergen. The recall affects 99 cases distributed to New York (Lot #24353).
Max Mobility Smart Drive MX2+ SpeedControl Dial wheelchairs are being recalled due to faulty circuit boards that may cause loss of device control, potentially resulting in injury to users.
A sevoflurane vaporizer component may degrade to hydrogen fluoride, causing respiratory damage and chemical burns to patients and workers. FDA classified this Class I recall affecting six units in Kentucky and Connecticut.
Wismettac Asian Foods, Inc. is recalling Shirakiku brand Curvee Puffs Corn Puff Snack due to undeclared milk on the label. Consumers with dairy allergies should not consume this product.
Wismettac Asian Foods is recalling Shirakiku brand Curvee Puffs Corn Puff Snacks due to undeclared milk. The product poses a serious risk to consumers with milk allergies. All lots distributed nationwide are affected.
Exactech is recalling certain AcuMatch XLE hip implant liners due to a missing ethylene vinyl alcohol barrier layer. The missing barrier may affect the implant's performance.
Sweet Cream Mini Patisseries frozen pastry trays are being recalled due to potential Salmonella contamination. Affected products were distributed in New Jersey and Florida with best-before dates through November 2025.
Cardinal Health is recalling Presource Kits (surgical strips and patties used in ophthalmic procedures) due to potential endotoxin contamination in non-sterile components.
AvKARE is recalling Irbesartan Tablets USP 300 mg due to dissolution failure, affecting 341 cartons distributed nationwide. Patients should contact their pharmacist or doctor regarding their medication.
Riverside Natural Foods is recalling Strawberry Granola Bars nationwide due to potential metal contamination. Consumers should stop consuming the product and dispose of it safely.
Cardinal Health Presource Kits may contain endotoxin-contaminated non-sterile surgical strips and patties. These kits are used in surgical procedures and have been distributed worldwide including the US, Canada, and Saudi Arabia. Affected facilities should verify lot numbers against the recall list.
Riverside Natural Foods is recalling Chocolate Drizzled Cookie Crumble Granola Bars distributed nationwide due to potential metal contamination. Approximately 2.4 million cases are affected.
Riverside Natural Foods is recalling Chocolate Chip Granola Mini Bars due to potential metal contamination. Approximately 2.4 million cases distributed nationwide are affected.
Riverside Natural Foods has recalled Holiday Sprinkles Chocolate Drizzled Granola Mini Bars nationwide because the product may contain metal pieces. Consumers should not consume these bars.
Cardinal Health is recalling certain Presource ACDF Kits due to potential endotoxin contamination in non-sterile surgical strips and patties used in spinal fusion procedures.
Stryker Corporation is recalling 622 units of Precision Thin blade attachments that may be out of measurement specifications, preventing them from fitting securely into compatible handpieces.
The Candy Basket Inc. is recalling Orange Jelly Sticks DARK candy distributed in California, Oregon, and Washington because the product labels do not disclose Yellow #6 dye and Sodium Benzoate preservative.
Cardinal Health Presource surgical kits containing non-sterile strips and patties may be contaminated with endotoxins, posing potential risk to patients during surgical procedures.
Cardinal Health is recalling Presource Robotic Hysterectomy Kits due to potential endotoxin contamination in surgical strips and patties. Endotoxins are bacterial contaminants that could cause complications during surgical procedures.