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.
Gills Onions is recalling diced red onions that may be contaminated with Salmonella Thompson. Consumers with affected product lots should not consume them.
Gills Onions is recalling fresh diced yellow onions due to potential contamination with Salmonella Thompson. The recalled product was distributed to multiple US states and Canadian provinces.
Gills Onions, LLC recalls Cross Valley Farms fresh slivered yellow onions for potential Salmonella Thompson contamination. The 1,800 lb recall affects 37 U.S. states and 5 Canadian provinces.
Pfizer Inc. is recalling 21,390 vials of Lidocaine Hydrochloride 1% injection due to presence of glass particulate matter. Lot 42290DK with expiration 6/1/2024 is affected.
Kula Brands is recalling Piña Colada + Kratom Seltzer because it contains undeclared milk and coconut allergens and unapproved kratom. Affected consumers should not consume the product.
Cordis US Corp is recalling cardiac catheter sets (Lot 18223410) distributed in Oklahoma. The devices were non-sterile but labeled as sterile, creating infection risk to patients.
Gills Onions, LLC is recalling Imperial Fresh diced red onions due to potential Salmonella Thompson contamination. The affected product was distributed across the United States and Canada.
Gills Onions is recalling 8 oz cups of diced red onions due to potential Salmonella Thompson contamination. Products were distributed across the US and Canada.
Gills Onions is recalling Imperial Fresh diced yellow onions (2,035 lb) due to potential contamination with Salmonella Thompson. The affected product was distributed to multiple US states and Canadian provinces.
WANABANA apple cinnamon fruit puree pouches are recalled due to high levels of lead detected by the North Carolina Department of Health and Human Services. Approximately 2.99 million units are affected across multiple regions.
CareFusion is recalling the Alaris PCA Module 8120 infusion pump because its labeling lists compatible syringes that have not been validated for use with the device.
Pfizer is recalling 3,200 vials of Lidocaine Hydrochloride 2% Injection due to the presence of glass particulates. The injectable medication was distributed nationwide in the US and Puerto Rico.
Gills Onions is recalling Ready Set Serve sliced onions due to potential Salmonella Thompson contamination. Affected consumers should not consume the product.
Gills Onions, LLC is recalling Cross Valley Farms fresh diced red onions due to potential Salmonella Thompson contamination. The recalled product was distributed across multiple U.S. states and Canadian provinces.
Gills Onions is recalling Cross Valley Farms diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed to 36 U.S. states and five Canadian provinces.
Gills Onions is recalling 3 lb. bags of diced yellow onions potentially contaminated with Salmonella Thompson. Affected products have specific lot numbers and use-by dates through August 28, 2023.
Gills Onions is recalling Imperial Fresh slivered yellow onions due to potential Salmonella Thompson contamination. The recall affects onions distributed across the United States and Canada.
Tiffany Food Corp. is recalling Mini Fruit Jelly Cups with lychee flavor because they pose a choking hazard. The recall covers 120 cases distributed in New York, New Jersey, and Pennsylvania.
Gills Onions is recalling fresh slivered yellow onions due to potential Salmonella Thompson contamination. Products were distributed throughout the United States and Canada.
Gills Onions is recalling 1/5 pound containers of fresh diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.
Gills Onions is recalling Imperial Fresh slivered yellow onions due to potential Salmonella Thompson contamination. The recall affects products distributed across the US and Canada.
Gills Onions has recalled slivered red onions due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.
Gills Onions is recalling 325 lb of fresh diced red onions due to potential Salmonella Thompson contamination. The product was distributed across multiple U.S. states and Canadian provinces.
Gills Onions is recalling Imperial Fresh slivered red onions (760 lb) due to potential Salmonella Thompson contamination. Affected lot codes were distributed to 38 US states and five Canadian provinces.
Safeway Fresh Foods LLC is recalling 528 cases of HEB Kale Greens (16 oz.) due to possible Listeria monocytogenes contamination. Affected product distributed in Texas with expiration dates 10/11/23 and 10/12/23.