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.
Cardinal Health is recalling 940,203 Convertor Isolation Gowns because raw materials may prevent them from meeting AAMI Level 3 protection specifications.
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.
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.
L & L Homemade Corn Salsa in 16 oz glass jars was voluntarily recalled because the product had a pH of 4.7, identified as unsafe. The recall affected 192 jars distributed in Illinois and Wisconsin.
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 100 mcg tablets for potency failures causing some tablets to be too strong and others too weak. Approximately 65,169 units are affected nationwide.
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.
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.
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.
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.
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.
FDC Limited is recalling Timolol Maleate eye drops (0.25%, 15mL bottles) due to a defective cap design where the spike may lodge in the bottle nozzle, preventing patients from dispensing the medication.
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.
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.
Hungryroot Ricotta Stuffed Shells are being recalled due to potential contamination with Listeria monocytogenes. Affected products have been distributed in multiple states.
Micro-X Ltd. is recalling five MICRO-X Rover Mobile X-ray Systems due to a timing defect that prevents adequate X-ray exposures. The 4 millisecond exposure time does not allow sufficient tolerance for diagnostic-quality imaging.
Mylan Institutional is recalling Levothyroxine Sodium tablets nationwide due to subpotent and superpotent units. Patients taking affected tablets may receive incorrect doses of this thyroid medication.
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.
Sysco Corporation is recalling Cucumber Chunk & Tomato Wedge products due to potential Salmonella contamination in cucumbers. Products were distributed in Iowa, Minnesota, South Dakota, North Dakota, Wisconsin, and Canada.
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.
Viatris Inc recalls 92,512 bottles of Levothyroxine Sodium tablets with potency failures—some are stronger than intended, others are weaker than intended.
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.
A software issue in the BD Pyxis CII Safe ES automated dispensing cabinet may cause it to open the wrong medication pocket, risking incorrect medication removal or refills.
Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 137 mcg due to potency failures in some tablets being stronger or weaker than specified. The recall affects 118,324 bottles distributed nationwide in the United States and Puerto Rico.
Mylan Institutional recalls levothyroxine sodium tablets (lot 3115707) due to subpotent and superpotent tablets. The product was distributed nationwide. Consult your healthcare provider.