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.
DeIorio Foods has recalled frozen pizza dough sheets that may contain conveyor belt pieces. The recall affects products distributed in CA, NC, and PA with best-use dates of 02/16/2024.
BE Pharmaceuticals recalls Fosaprepitant for Injection nationwide due to failed aseptic process validation. The 22,176 vials from lot #13D012AA may lack sterility assurance.
Kent Imaging's Snapshot NIR tissue oxygenation measurement system touchscreens may become unresponsive, preventing users from viewing diagnostic oxygenation images. Fifty-seven units have been distributed across multiple US states and Malaysia.
Sun Pharmaceutical recalls 6,552 bottles of Niacin Extended-Release Tablets (1000mg) nationwide due to microbial contamination in manufacturing equipment. No illnesses have been reported.
DiaSorin LIAISON HSV-2 Type Specific IgG test kits are being recalled because specific lots may produce false positive or equivocal results. Affected kits were distributed in the US and Canada.
Sun Pharmaceutical recalls 9,408 bottles of Lurasidone Hydrochloride 120mg tablets nationwide due to microbial contamination discovered in manufacturing equipment.
C.R. Bard is recalling 26,100 nasogastric sump tubes due to user complaints of inadequate suction and reduced drainage. The malfunction could prevent proper stomach decompression.
Medtronic is recalling Cobalt XT DR MRI implantable cardioverter defibrillators due to a manufacturing defect in the battery testing process. Some batteries may have bypassed required validation.
Sun Pharmaceutical is recalling Febuxostat 80 mg tablets due to microbial contamination in manufacturing equipment. Approximately 19,992 bottles were distributed nationwide.
C.R. Bard is recalling Bard Nasogastric Sump Tubes due to reports of inadequate or reduced suction, decompression, and drainage during use. The recall affects 57,159 units distributed in the United States.
Lara's Bakery 3 LLC is recalling Tres Leches cake for undeclared wheat, a major allergen not listed despite being in the ingredient list. Consumers with wheat allergies could face allergic reactions.
Strides Pharma recalls Methoxsalen 10mg capsules (Lot #7253092B) due to failed dissolution specifications that could reduce medication effectiveness.
B-K Medical A/S is recalling bkActiv Ultrasound System 2300 models because a measurement error could occur in the Dual Live Compare feature, potentially affecting diagnostic accuracy.
C.R. Bard is recalling 51,750 Bard Nasogastric Sump Tubes with PreVent Anti-Reflux Filter due to reports of inadequate suction and drainage during use.
365 Whole Foods Vegan Ultimate Veggie pizza (13.7 oz, UPC 0 99482-51870 7) is recalled for undeclared milk. Consumers with milk allergies should not consume this product. It was distributed to GA, PA, TX, and WA.
Lecoq Cuisine Corporation is recalling RTB Mixed Danish Variety pastries due to undeclared soy lecithin. The recall affects 7,620 units distributed across 26 states.
The TactiFlex Ablation Catheter is not correctly recognized by the EnSiteX EP System, which displays it as a different model, prevents certain features from appearing, and may show an inverted image.
Beckman Coulter is recalling 112 units of iQ200 Series Urine Microscopy Analyzers distributed globally. The cannula in the Flowcell and Rinse Waste Well Assembly may rust, potentially causing erroneous diagnostic results.
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products used to test for Hepatitis B antibodies due to potential calibration failures and falsely elevated test results affecting specific lot numbers.
Beckman Coulter recalled the REV 2 Flowcell Capsule Spare due to potential rust in the cannula component, which could generate erroneous test results.
Sun Pharmaceutical is recalling Fexofenadine Hydrochloride 180mg tablets due to microbial contamination discovered in manufacturing equipment. Approximately 54,504 bottles distributed nationwide are affected by this Class II recall.
C.R. Bard is recalling Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction and drainage during use. The defect may prevent proper gastric decompression.
C.R. Bard has recalled certain nasogastric sump tubes due to user reports of inadequate suction and drainage. The affected devices may fail to properly decompress the stomach.
Phadia Ab recalls 124,928 EliA GBM Wells diagnostic kits distributed nationwide due to complaints of false positive results. The wells produced unexpected positive signals in samples tested without antigen.
United Natural Trading Inc. is recalling Odds & Ends Organic Chocolate Fruit & Nut Mix due to the presence of stems and vegetation. The product was distributed to Maryland, Oregon, and Massachusetts.