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.
Soft Zero on the Go brand Lite Peanut Butter ice cream is being recalled due to potential Listeria monocytogenes contamination. The affected product was distributed across multiple U.S. states and internationally.
Real Kosher Ice Cream recalls Soft Serve on the Go Peanut Butter ice cream due to potential Listeria contamination. Consumers should discard the product or return it.
Freshy Foods, LLC is recalling Team Fresh & Go Pineapple Cups due to potential Listeria monocytogenes contamination. The recall affects 214 units distributed in Florida, Louisiana, and Mississippi.
Real Kosher Ice Cream, Inc. is recalling Soft Serve on the Go brand Strawberry Mango Sorbet due to potential Listeria monocytogenes contamination. The product was distributed across multiple U.S. states and international locations.
Freshy Foods is recalling Team Fresh & Go Cantaloupe Cups due to potential Listeria monocytogenes contamination. The affected product was distributed in Florida, Louisiana, and Mississippi.
A reagent carryover issue in Siemens ADVIA Chemistry urinary protein test kits can cause falsely low creatinine test results. The problem occurs when the creatinine test is run after the protein test on the same system.
Medicrea International is recalling 5 units of IMPIX ALIF intervertebral fusion devices due to a potential packaging defect—a pinhole in the inner or outer pouch.
Smith & Nephew recalled a femur nail surgical implant because some packages contained a 40cm product instead of the labeled 36cm version. No injuries have been reported.
Inmar Supply Chain Solutions recalls multiple FDA-regulated food and dietary supplement products purchased from May 2022 onward due to potential rodent exposure in their Texas warehouse.
Crispy Bagel Co. is recalling Blueberry Artificially Flavored Bagels sold at Lidl for containing undeclared sesame. Approximately 3,020 units were distributed to stores in Virginia, North Carolina, and Maryland.
Inmar Supply Chain Solutions is recalling all OTC drug products due to potential rodent exposure in its distribution center and temperature excursions during storage that may have compromised product integrity.
NAD+ 200mg/ml vials from Tailor Made Compounding are recalled nationwide due to lack of assurance of sterility (Lot#07192307A2, BUD 11/18/2023). Consumers should discontinue use and consult their healthcare provider.
Boston Scientific recalls the EMBLEM MRI S-ICD Pulse Generator due to a rare interaction with the LATITUDE communicator that may disable the device's sensing capability for up to 24 hours.
Frito-Lay is recalling specific batches of Doritos Nacho Cheese Flavored Tortilla Chips because they may contain undeclared soy and wheat, which are major allergens.
BioFire Diagnostics recalled FilmArray Pneumonia Panel diagnostic kits due to a manufacturing defect that may produce false negative results, potentially causing missed pneumonia diagnoses.
Boston Scientific is recalling 3,856 EMBLEM S-ICD heart devices due to a rare interaction with the LATITUDE communicator that may disable sensing of dangerous heart rhythms for up to 24 hours.
Medicrea International is recalling GRANVIA-C cervical intervertebral fusion devices due to a packaging non-conformity issue presenting as pinholes in inner or outer pouches, which could compromise sterility.
BioFire Respiratory Panel 2.1 kits for FILMARRAY systems may return false negative results due to a manufacturing defect. The recall affects 705 kits distributed to healthcare facilities in the U.S. and select international locations.
Ecometics, Inc. is recalling 32,583 bottles of Sodium Fluoride 0.96% Activator Concentrate nationwide due to manufacturing practice deviations. The product was not manufactured under current good manufacturing practices (CGMP).
Medicrea International is recalling 248 units of IMPIX 3D intervertebral fusion devices due to pinholes in the product packaging. The recall covers devices distributed nationwide.
Pearson Foods Corporation is recalling romaine lettuce due to potential contamination with deer feces. The affected product was distributed in Illinois, and consumers should not consume it.
Randox Laboratories recalled 166 units of Liquid Protein Calibrators (IT2691) after restandardization caused Ferritin results to read approximately 10% higher than targeted calibrator values.
Smith & Nephew is recalling 32 units of a femoral nail implant due to labeling mismatch. The package contained 40cm implants but was labeled as 36cm, which could result in incorrect surgical implantation.
Aurobindo Pharma USA Inc. is recalling Rufinamide 200 mg tablets (Lot RB2023001A) because a batch was released prior to manufacturing approval. The FDA classified this as a Class II recall.
Dolomite Gloss Rollator models may experience seat failure and structural collapse due to broken eyelets and crossbar, potentially causing user injury. About 586 units nationwide are affected.