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.
Ascend Laboratories is recalling Dabigatran Etexilate 75 mg capsules nationwide due to manufacturing deviations. Three lots contain N-nitroso-Dabigatran impurity above recommended interim limits.
DesBio lunaSOMM Natural Sleep Support Dietary Supplement is recalled due to undeclared soy lecithin. The product is labeled as containing sunflower lecithin but contains soy lecithin, posing a risk to consumers with soy allergies.
7-Eleven Chicken Salad Sandwiches (UPC 7 63913-79486 1) are mislabeled and actually contain tuna salad. The product poses a risk to consumers with tuna allergies.
Joseph Epstein Food Enterprises recalls Mama Mancini's Stuffed Shells with Sauce and Mozzarella Cheese due to potential Listeria monocytogenes contamination. Affected products were distributed to six states.
Viatris Inc is recalling Levothyroxine Sodium 100 mcg tablets for potency failures causing some tablets to be too strong and others too weak. Approximately 65,169 units are affected nationwide.
Micro-X Ltd. is recalling 23 MICRO-X Rover Mobile X-ray Systems because the hand switch may be accidentally activated when dropped, causing the system to become unresponsive during patient imaging.
Viatris Inc recalls 92,512 bottles of Levothyroxine Sodium tablets with potency failures—some are stronger than intended, others are weaker than intended.
Piazza Produce is recalling 289 units of CIBUS Fresh Autumn Turkey Sandwiches due to possible Listeria monocytogenes contamination in the spreadable brie ingredient. Products were distributed in six states with expiration dates from November 1-9, 2024.
Microline Surgical is recalling ReNew Microscissor Tip (Disposable) lot 00172110 due to a 2% failure rate where the heat shrink breaks off.
Viatris Inc is recalling Levothyroxine Sodium Tablets 25 mcg nationwide due to potency failures. Some tablets are superpotent while others are subpotent, which could affect medication effectiveness.
Beckman Coulter recalls an Access Intact PTH assay used on the DxI 9000 analyzer because samples stored on the device may produce falsely low hormone-level results, potentially leading to missed diagnosis or delayed treatment.
Tipp Distributors is recalling Jarritos Coconut Water 17.5 fl oz cans due to potentially compromised hermetic seals on the lids. The recall affects 169,438 cases distributed in 29 U.S. states.
Fresh Gourmet tortilla strips are recalled due to undeclared wheat found in crispy onion pieces mixed into the product. Consumers with wheat allergies are at risk.
Viatris Inc. is recalling 19,549 bottles of Levothyroxine Sodium 175 mcg tablets nationwide due to potency failures. Some tablets contain excessive active ingredient while others contain insufficient amounts.
Mylan Institutional recalls 690 cartons of Levothyroxine Sodium 150 mcg tablets nationwide due to potency variation. Some units may be subpotent or superpotent.
Philips Allura Xper radiological systems may experience propeller motor and x-ray tube locking bolt breaks, causing erratic C-arm movements with potential for collision with patients or bystanders, and unnecessary radiation exposure.
An automated medication dispensing cabinet may open the wrong storage pocket due to a software malfunction, potentially leading to incorrect medication removal. The manufacturer is recalling affected units.
Viatris Inc is recalling 35,883 bottles of Levothyroxine Sodium Tablets (112 mcg) distributed nationwide due to potency failures. Some tablets contain too much active ingredient (superpotent) and others too little (subpotent). No illnesses have been reported.
Sweet Sam's Baking Company is recalling 10,164 units of Individually Wrapped Chocolate Chunk Brownies due to undeclared soy lecithin, a major allergen. Consumers with soy allergies face a potential health risk from this labeling oversight.
Viatris Inc. is recalling 42,331 bottles of Levothyroxine Sodium Tablets 50 mcg distributed nationwide due to potency failures resulting in both superpotent and subpotent tablets.
Cardinal Health is recalling 940,203 SMS Elastic Cuff Thumbhook Level 3 Isolation Gowns because the raw materials may fail hydrostatic pressure specifications, preventing them from meeting required AAMI Level 3 protection standards.
DiaSorin Inc. is recalling over 21,900 LIAISON Q.S.E.T. Device Plus units worldwide due to loose caps that may leak buffer, potentially resulting in incorrect stool sample test results.
Hungryroot Ricotta Stuffed Shells are being recalled due to potential contamination with Listeria monocytogenes. Affected products have been distributed in multiple states.
Mylan Institutional is recalling 1,664 cartons of levothyroxine sodium tablets nationwide due to potency variance. The tablets contain subpotent and superpotent units, affecting the consistency of each dose.
Hermes Medical Solutions is recalling Hybrid Recon software (versions 4.0.0x and 5.0.0) due to a potential software configuration issue that may cause incorrect alignment during SPECT/CT image reconstruction. The issue affects 778 systems in the U.S. and internationally.