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.
McKesson Medical-Surgical is recalling Rocuronium Bromide Injection vials due to storage outside label specifications. Seventy vials were distributed to three healthcare accounts in New Mexico, Arizona, and Utah.
TRP Natural Eyes Pink Eye Relief sterile eye drops are being recalled due to lack of assurance of sterility. The recall affects 139,656 bottles distributed nationwide.
Siemens has recalled the Atellica IM Erythropoietin assay due to a 35% negative bias compared to WHO standards. The assay does not achieve claimed reference intervals and could report inaccurate test results.
Optikem International, Inc. is recalling TRP Natural Eyes Dryness Relief eye drops due to lack of assurance of sterility. The product was distributed nationwide in the USA.
Baxter Healthcare recalls CLEARLINK Non-DEHP Solution Set Luer Lock Adapters due to potential leaks in the drip chamber. The recall affects 26,592 units distributed nationwide.
KALO Carrot Cake All Natural Gluten Free is mislabeled with Chocolate Cake ingredient information that omits soy, creating an allergen hazard for consumers with soy allergy.
The FDA is recalling 106,704 bottles of TRP Natural Eyes Red Eye Relief eye drops due to lack of sterility assurance. Consumers should stop using the product and contact a healthcare provider if they experience eye irritation or infection.
Baxter Healthcare is recalling STERIS Boot Assembly traction devices due to an incorrectly oriented locking pin that may cause the boot to detach during surgery, posing patient safety risks.
The FDA is advising on label interpretation for the SPII Model Lubinus hip prosthesis stem to prevent confusion during surgery. Two complaints prompted additional guidance on carton label size and type columns.
Sun Pharmaceutical is recalling 47,520 bottles of Febuxostat 40mg tablets nationwide due to microbial contamination found in manufacturing equipment. The FDA classified this as a Class II recall; no illnesses have been reported.
A hip prosthesis stem was recalled due to ambiguous carton label guidance that could cause incorrect implant selection during surgery. The recall affects 382 units.
Capitol Commissary LLC is recalling Jacksons Chicken Salad On A Croissant due to potential sesame cross contact. The product was distributed in seven western states.
Fresenius Kabi recalls Ivenix Infusion System software versions 5.2.1 and 5.2.2 due to two defects that may delay therapy or cause over-infusion. The software fix was deployed to affected units between May and August 2023.
FDA has recalled the D-Clip Standard/Mini Applier due to reports that the device failed to release the clip and remained attached during surgical use, creating a risk of surgical complications.
Optikem International is recalling 46,621 bottles of hyalogic For Dry Eyes, HylaTears Lubricant Eye Drops due to lack of assurance of sterility. The product is distributed nationwide.
Capitol Commissary LLC recalled CK Egg Salad Sandwich due to potential sesame cross-contact. Affected units were distributed in seven western U.S. states; consumers should not eat the product.
Capitol Commissary LLC is recalling 1,195 units of Jacksons Egg Salad sandwiches due to potential cross contact with sesame. Consumers with sesame allergies should not consume the affected product.
Capitol Commissary LLC is recalling CK Chicken Salad On A Croissant due to potential cross-contact with sesame. The recall affects 29 units distributed across seven Western states.
TRP Eye Twitching Relief sterile eye drops are being recalled nationwide because the manufacturer cannot assure the product meets sterility requirements. The affected lot (C303, expiring 07-27-2025) was distributed in the USA.
Fresenius Kabi is recalling software versions 5.0.1 and earlier of the Ivenix Infusion System due to a software defect that may cause an incorrect pump alarm, potentially delaying therapy. The defect was resolved in software version 5.2.1, released in September 2022.
Beaver Visitec International is recalling 3,000 BVI Visitec Irrigation Handles because the pack and pouch labels are missing manufacturing and expiration date information.
Waldemar Link is clarifying labeling on 153 hip prosthesis units after complaints about ambiguous Size and Type information. The guidance aims to prevent potential misinterpretation during surgery.
Electric City Sweets 1.75oz Red Velvet Milk Chocolate Bars are being recalled because milk is not properly declared on the packaging. The recall affects 1,644 bars distributed in California, Florida, Pennsylvania, and North Carolina.
Vitony Bakery cheesecake products are being recalled due to undeclared FD&C Yellow #5 and Yellow #6 dyes. The recall affects 6,916 units distributed to Puerto Rico and may pose risks to consumers with sensitivities to these colorants.
Global Corporation is recalling Broncochem Cold & Flu Syrup Kids (120 mL bottles) nationwide due to stability testing failures in active pharmaceutical ingredients.