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.
Pita Jungle Hummus & Pita Chips snack packs are being recalled because the product label fails to declare sesame, an ingredient in the hummus. Consumers with sesame allergies may face health risks.
ProRx LLC is recalling approximately 8,396 vials of compounded semaglutide due to lack of assurance of sterility. The medication was distributed nationwide.
Mindray's Desflurane E_Vap vaporizer may deliver anesthetic at higher concentrations than set due to an incomplete seal. Patients could inhale excessive anesthetic, potentially causing dizziness, drowsiness, and in severe cases, neurological effects.
Reser's Fine Foods recalls Item 71117.14459 Gravy Homestyle due to temperature abuse during shipping. The product may become spoiled and pose food safety risks.
Abiomed updated Impella 5.5 cardiac pump labeling to document a potential interaction with Shockwave Coronary IVL Catheter during coronary procedures. No injuries have been reported.
SSP America PHX, LLC recalls Pita Jungle Cilantro Jalapeno Hummus & Pita Chips snack packs due to undeclared sesame allergen on the label. Consumers with sesame allergy risk serious allergic reactions.
WR Coffee Inc recalled 90 Ham and Cheese Croissants distributed in Texas due to potential Listeria monocytogenes contamination.
ProRx LLC is recalling 1,732 vials of Tirzepatide 60 mg/3mL nationwide due to lack of assurance of sterility. Affected lots have beyond-use dates of 11/21/2024 and 12/09/2024.
Reser's Fine Foods recalls 6 cases of Item 71117.03034 Banana Pudding Kit due to temperature abuse from a malfunctioning refrigeration unit. Affected products were distributed to CA, IL, MN, ND, and SD.
Reser's Fine Foods is recalling 182 cases of Potatoes Creamy Deluxe Special Request due to temperature abuse that may cause food spoilage.
Reser's Fine Foods is recalling Stonemill Kitchens Green Goddess Pasta Salad due to potential spoilage from temperature abuse caused by a malfunctioning refrigeration unit. The product was distributed in CA, IL, MN, ND, and SD.
The adhesive joint in this medical device component can fail, causing the metal part to detach. This may damage the centrifuge, destroy patient samples, and potentially expose lab staff to biohazardous material.
W L Gore & Associates is recalling Heparin Gore Viabahn VBX Balloon Expandable Endoprosthesis devices due to packaging defects that may compromise sterility assurance and heparin activity.
ProRx LLC is recalling 37 vials of compounded Tirzepatide injectable due to lack of sterility assurance. The 2 mL vials (10 mg/mL and 20 mg/mL) were distributed nationwide.
Reser's Fine Foods recalls 18 cases of Raspberry Parfait Desserts due to temperature abuse during transport that may have caused spoilage. Products with use-by date 12/4/2024 distributed in CA, IL, MN, ND, and SD.
SSP America PHX is recalling Apple Danish products due to incorrect ingredient labeling. The label lists Almond Croissant ingredients instead of Apple Danish, creating a risk for consumers with tree nut allergies.
ProRx LLC is recalling compounded semaglutide injections due to lack of assurance of sterility. The recall affects 2,490 vials distributed nationwide.
Multiple apple juice brands sold nationwide are being recalled due to inorganic arsenic levels above FDA action thresholds. The recall affects approximately 141,298 cases sold by Refresco Beverages US Inc.
Reser's American Classics Macaroni & Cheese White Cheddar (12oz) is recalled due to potential spoilage caused by temperature abuse during distribution. Consumers should discard affected packages.
Philips Azurion 7M20 interventional fluoroscopic X-ray systems with FlexArm ceiling-mounted stands may experience inconsistent or unavailable longitudinal movement due to bearing grease leakage affecting device mobility. Approximately 927 systems worldwide are affected.
Reser's American Classics Egg Salad has been recalled due to potential spoilage caused by temperature abuse from a malfunctioning refrigeration unit. The affected product was distributed in five states.
Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures.
Reser's Fine Foods recalls Asiago Creamed Spinach due to potential spoilage from temperature abuse during transport. The affected product has a use-by date of August 31, 2024.
Abiomed is updating labeling for Impella CP Smart Assist pumps to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. The interaction was previously undocumented in device labeling.
Reser's Essential Everyday Original Potato Salad recalled due to potential spoilage from temperature abuse affecting refrigerated units. Affected cases distributed in CA, IL, MN, ND, and SD.