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.
Penzeys, Ltd. is recalling Brady Street Cheese Sprinkle because it may contain sesame, which is not declared on the label. People with sesame allergies should not consume this product.
Universal Meditech Inc. recalled DiagnosUS hCG pregnancy test strips because the company distributed them without FDA marketing authorization and cannot provide manufacturing compliance documentation. The firm is ceasing operations.
Medtronic is recalling specific serial numbers of Grafton DBM Matrix Strips due to a potential defect in the outer Tyvek pouch resulting from a missed inspection step during manufacturing.
Universal Meditech Inc. is recalling multiple diagnostic test strips (breastmilk alcohol, SARS-CoV-2 antibody, and ketone tests) distributed in the U.S. and Taiwan because the company is closing and cannot provide documentation of manufacturing compliance or post-market surveillance records.
Denver Solutions is recalling 33,480 Vancomycin HCI IV bags (NDC 71449-028-68) due to a labeling issue. The affected lots were distributed nationwide.
Empatica has recalled 1,360 units of its Embrace2 seizure monitoring wearable due to potential battery life lasting less than the specified 48 hours, requiring more frequent charging.
Medtronic is recalling 377 units of Grafton DMB Matrix demineralized bone matrix devices due to potential defects in the outer Tyvek pouch from a missed manufacturing inspection step. No patient injuries have been reported.
Denver Solutions recalls 6,276 IV bags of oxytocin due to a labeling defect. The product was distributed nationwide to healthcare facilities.
Medtronic is recalling Grafton DBM Putty bone matrix implants because the outer Tyvek pouch inspection step may not have been performed, potentially releasing non-conforming batches.
Denver Solutions, LLC is recalling 25,908 Vancomycin HCI IV bags distributed nationwide due to a labeling issue. Affected lots include products with expiration dates from October 2023 through January 2024.
West-Ward Columbus Inc is recalling Methotrexate Sodium 2.5 mg tablets because some tablets have unsmooth surfaces and illegible identification markings. The recall affects 2,673 cartons distributed to MS and OH.
Sheng Kee Bakery mooncakes recalled for undeclared egg allergen across CA, IL, TX, GA, WA, and NJ. Consumers with egg allergies should not consume.
Sheng Kee Bakery is recalling mooncakes due to undeclared egg allergen. Consumers with egg allergies should not consume this product.
Sheng Kee Bakery is recalling Large 4-Red Bean Mooncake Gift Boxes distributed in six states due to undeclared egg allergen. Consumers with egg allergies should not consume the product.
La Perla Inc is recalling Oasis Mediterranean Cuisine Thin & Crunchy Sea Salt Hommus Chips because sesame is not declared on the label. The product was distributed in Ohio with a Best By date of 12/21/23.
KVK-Tech's Betaxolol Hydrochloride tablets (10 mg, lot 17853A) are being recalled nationwide due to potential contamination with oxycodone tablets. Patients should stop using affected bottles immediately and contact their healthcare provider.
Olympus recalls the UHI-4 High-Flow Insufflation Unit used in laparoscopic surgery after reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures. Incidents may result from over insufflation of the abdominal cavity.
Sheng Kee of California is recalling Large 4-Date Mooncake Gift Boxes due to undeclared egg allergen. The product was distributed to multiple U.S. states.
VistaPharm is recalling 180 bottles of Sucralfate Oral Suspension nationwide due to Bacillus cereus contamination, a Class I recall. The affected lot (810300, expiring October 2023) should not be used.
Sheng Kee Bakery is recalling Large 4-Lotus Pine Nut Mooncake Gift Boxes because they contain undeclared egg, a major allergen. The product was distributed in California, Illinois, Texas, Georgia, Washington, and New Jersey.
Sapphire Infusion Pumps with software revisions 16.10.1 or 16.10.2 may fail to detect air in the infusion line, potentially causing life-threatening air embolism. Approximately 1,383 units have been distributed nationwide.
FDA recalls TheraBreath for Kids Oral Rinse due to microbial contamination identified as Candida parapsilosis yeast. Approximately 5,316 bottles distributed nationwide are affected.
Pine Pharmaceuticals recalls 2,176 syringes of compounded moxifloxacin nationwide due to inadequate sterility assurance. The product was distributed to healthcare providers and patients.
MEDLINE ReNewal Harmonic ACE+7 surgical shears may have incomplete seals on packaging trays. Approximately 18 units were distributed in the United States. Affected products should not be used.
Pine Pharmaceuticals is recalling Calcium Gluconate 2.5% inhalation solution due to lack of sterility assurance. Patients should stop using affected syringes and contact their healthcare provider.