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.
IBSA Pharma voluntarily recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency concerns. Affected lots are 220416 (Exp. 10/2023) and 221053 (Exp. 4/2024).
Siemens is recalling ADVIA Centaur Folate 500 test kits because a calibration error causes inaccurate, falsely low results when testing serum samples, potentially affecting diagnostic accuracy.
Pilgrim's Roasted Nut'Z Creme Brulee Cashews are recalled for undeclared walnut. The product was distributed in California, Oregon, and Washington and poses a risk to consumers with walnut allergies.
Medline Industries recalls approximately 720 Sterile Maximum Barrier Pack-LF units due to improper component placement preventing sterilization. The affected packs were distributed in Arkansas, Colorado, and Georgia.
IBSA Pharma is recalling TIROSINT levothyroxine sodium oral solution nationwide due to subpotent drug content. The recall affects lots 220413 and 220964.
Nature's Eats Cashew Crave Mix 8 oz. is recalled for undeclared milk and soy allergens. The allergens are present in the product but not declared in the main 'Contains' statement.
Dr. Reddy's Laboratories is recalling Tacrolimus 0.5 mg capsules due to the presence of one 1 mg capsule co-mingled in affected bottles. The mismatched capsule could lead to incorrect dosing in immunosuppressed patients.
Hologic is recalling 797 units of its 3Dimensions/Selenia Dimensions mammography systems nationwide due to unexpected C-arm movement that may cause blunt trauma.
Pilgrim's Roasted Nut'Z Tri-Colored Chocolate Espresso Beans are recalled due to undeclared soy lecithin. Consumers with soy allergies may experience allergic reactions.
Cardinal Health is recalling Presource Packs IV START TRAY I kits due to a manufacturing defect in the ICU MicroClave Clear Connector that may cause fluid leaks and loss of fluid path integrity.
IBSA PHARMA is recalling TIROSINT (levothyroxine sodium) oral solution due to subpotency in specific batches. The affected product may contain less active ingredient than labeled.
IBSA Pharma Inc. recalls TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotent formulation containing less active ingredient than labeled.
IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotency. Two lot numbers are affected: Lot #220407 (Exp. 10/2023) and Lot #220960 (Exp. 03/2024).
Siemens recalls Luminos Agile imaging systems that may collide with ceilings or walls due to default configuration settings, potentially causing serious injury to staff or patients.
Medline is recalling sterile oncology port access trays in which some components were not properly sterilized due to improper placement during manufacturing. Healthcare facilities should immediately discontinue use of affected units.
Siemens is recalling ADVIA Centaur diagnostic test kits used to detect hepatitis B antibodies due to test interference that can produce false positive results when performed before another hepatitis B test on the same sample.
IBSA Pharma has recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency. Affected lots 220418 and 220560 may contain insufficient active ingredient for proper thyroid hormone replacement therapy.
B. Braun Medical's 0.9% Sodium Chloride Injection batches recalled due to risk of incomplete seals that could allow leakage, potentially compromising sterility. The recall affects 1,343,982 bags distributed nationwide.
Access Vascular is recalling the HydroMID 4Fr Single Lumen Maximal Barrier Kit because the outer bag and inner Tyvek header bag are mislabeled. The device is used for short-term peripheral venous access.
Pilgrim's Roasted Nut'Z White Chocolate Raspberry Cashews are recalled due to undeclared milk and soy lecithin. The product was distributed in California, Oregon, and Washington.
Pilgrim's Roasted Nut'Z Garlic, Parmesan, Cracked Black Pepper Hazelnuts are recalled due to undeclared milk, a major allergen.
IBSA Pharma Inc. recalled TIROSINT levothyroxine sodium lot 220853 nationwide due to subpotency. The oral solution may contain less active ingredient than labeled, potentially affecting thyroid hormone replacement therapy.
IBSA Pharma is recalling certain lots of TIROSINT (levothyroxine sodium) oral solution nationwide because the product contains less active ingredient than labeled. Patients using affected lots may not receive adequate thyroid hormone replacement.
Cardinal Health's Presource Packs IV START KIT is being recalled due to a manufacturing defect in the connector that may cause fluid leaks and compromise intravenous fluid delivery.
Siemens Healthcare Diagnostics is recalling 7,884 ADVIA Centaur Folate 500 diagnostic test kits because using whole blood calibration with serum samples produces negative bias and inaccurate results.