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.
County Fair Foods is recalling 42,000 bags of Popcorn Pre-Pop nationwide due to undeclared Yellow #5 dye. The voluntary recall was initiated because Yellow #5 was not declared on the product label.
Maquet Medical Systems is recalling the Bubble Sensor accessory for CARDIOHELP-i extracorporeal life support systems due to an incorrect UDI Device Identifier printed on the product label.
Greco Sidari is recalling President Goat Cheese (1375 cases) distributed in Ohio, New York, and Pennsylvania between November 26, 2023 and January 5, 2024 due to improper storage temperature that could support pathogen growth.
Amerisource Health Services LLC is recalling approximately 1,932 cartons of Febuxostat (40 mg tablets) nationwide due to deviations from current good manufacturing practices. The firm initiated the recall voluntarily on January 25, 2024.
Dr. Reddy's Laboratories is recalling Glimepiride 1mg tablets nationwide due to a printing defect on the tablet. The voluntary recall affects 14,425 bottles.
Medline Remedy Clinical antifungal cream is recalled for labeling that falsely claims to be paraben-free while the product actually contains parabens. About 1,786 tubes nationwide are affected.
Fujifilm is recalling sperm separation media kits because the lower layer component may not match the documented lot. The kits may contain an older component with a different shelf life, which could affect product performance.
Denver Solutions recalled 8,976 IV bags of fentanyl citrate nationwide due to a malfunction in the semi-automated filling system that could deliver double the intended dose.
Fat Choy Kee Dried Longan produced by HY SUCCESS INC. is being recalled because it contains undeclared sulfites. Sulfites are a known allergen that poses health risks to sensitive individuals.
Denver Solutions is recalling 7,548 IV bags of vancomycin due to a manufacturing system malfunction that can deliver double doses. The product was distributed nationwide.
GE HealthCare is recalling EvAir compressor kits for CARESCAPE and Engström ventilators due to elevated formaldehyde levels found in preliminary testing. The recall affects 1,294 units distributed worldwide.
The FDA has recalled Zenzedi (Dextroamphetamine Sulfate) 30 mg tablets due to a labeling error. The recall affects 4,662 bottles distributed nationwide.
Denver Solutions is recalling 29,016 Phenylephrine HCl IV bags distributed nationwide. A filling system malfunction can result in some bags receiving double doses of this potent injectable drug.
FDA recalls EVair 03 air compressors (models 1609000, 1609002) for elevated formaldehyde when used with certain ventilators. The hazard was identified during preliminary testing under worst-case conditions: elevated room temperature (40°C) and minimal gas flow (2 L/min).
Tio Francisco Yogurt products in multiple flavors are being recalled due to potential Listeria monocytogenes contamination. Consumers who have purchased these yogurts should not consume them.
Rizo Lopez Foods is recalling bulk Cheddar cheese due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.
Rizo Lopez Foods is recalling Tio Francisco Blanco Suave cheese due to potential Listeria monocytogenes contamination. Affected products have date codes through March 23, 2024.
Tio Francisco Queso Para Freir (frying cheese) is being recalled due to potential Listeria monocytogenes contamination. The recall affects multiple batches distributed across multiple U.S. states.
Bulk Monterey Jack cheese from Rizo Lopez Foods is being recalled due to Listeria monocytogenes contamination. The product was distributed to multiple U.S. states.
Multiple ricotta cheese products from Rizo Lopez Foods are recalled nationwide due to potential Listeria monocytogenes contamination. Affected batches have best-by dates through April 2, 2024.
Tio Francisco Requeson cheese products are recalled due to Listeria monocytogenes contamination. Consumers should not consume affected products and should return them to the store.
Ocean Group Inc. is recalling frozen salmon fillet products distributed in California due to potential Listeria monocytogenes contamination detected during FDA environmental sampling.
Melissa's Hot Kimchi Pickled Napa Cabbage is being recalled due to undeclared fish allergen. 124 cases were distributed to California, Texas, and Florida.
Ocean Group Inc. is recalling tuna products distributed in California due to potential Listeria monocytogenes contamination identified through FDA environmental sampling.
Olympus recalled 3,354 EZDilate wire-guided dilation balloons due to failures in inflation, deflation, and retrieval, with incidents of bursting, leaking, and foreign bodies left in patients.