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.
Greco Sidari fresh mozzarella cheese sold in Ohio, New York, and Pennsylvania was not held at appropriate temperatures, which could affect spoilage and potentially support pathogen growth. Consumers should discard affected products or return them to the retailer.
Amneal Pharmaceuticals is recalling Phenoxybenzamine Hydrochloride Capsules, 10mg, due to an unknown impurity. The recall affects 858 bottles distributed nationwide.
Howmedica Osteonics Corp. is recalling hip arthroplasty surgical instruments after their sterile packaging failed integrity testing. Units with compromised packaging were distributed worldwide.
Locatelli Crema Di Locatelli cheese was recalled because it was not held at appropriate temperatures. Improper holding temperatures could affect food safety by supporting spoilage and pathogen growth.
Becton Dickinson's BD BBL Sensi Disc Cefuroxime testing discs may have accuracy, reproducibility, or quality-control failures in antibiotic susceptibility testing. This could delay diagnosis and lead to inappropriate antibiotic selection.
BD BBL Sensi Disc Aztreonam test discs are recalled due to possible accuracy and quality control failures in antibiotic susceptibility testing. Failures could result in delayed diagnoses and inappropriate antibiotic selection.
Saputo Stella cheese distributed in OH, NY, and PA from November 26, 2023 through January 5, 2024 has been recalled due to improper temperature storage. The temperature failure could lead to spoilage and pathogenic growth.
Becton Dickinson is recalling BD BBL Sensi Disc Cefpodoxime testing discs due to potential accuracy failures in antibiotic susceptibility testing. The defect may cause inaccurate results, delayed diagnosis, or inappropriate antibiotic selection.
The FDA is recalling Lansoprazole Delayed-Release Capsules USP 15 mg due to manufacturing defects including inadequate sealing, capsule damage, and missing product codes. Affected lot 411987 was distributed nationwide.
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Tetracycline 30µg laboratory test kits due to potential accuracy and quality control failures in antibiotic susceptibility testing that could lead to delayed diagnosis or inappropriate antibiotic selection.
Greco Sidari is recalling 1375 cases of Galbani Domestic Mascarpone due to improper storage temperature. The product was not held at appropriate temperatures, which could allow spoilage and support pathogen growth. Affected products were distributed in OH, NY, and PA between November 26, 2023, and January 5, 2024.
BD BBL Sensi Disc Piperacillin/Tazobactam antibiotic susceptibility testing discs are recalled due to potential quality control and accuracy failures. These failures may cause delayed or inaccurate test results, affecting patient diagnosis and antibiotic treatment selection.
GRANDE SOPRAFFINA ricotta cheese was not held at appropriate temperatures, potentially supporting pathogen growth. Affected lots distributed to OH, NY, and PA from November 26, 2023 to January 5, 2024.
The Flow-c Anesthesia System model 6887700 has a cybersecurity vulnerability allowing potential denial of service, tampering, or remote code execution via remote login. Fourteen units were distributed in the United States.
Becton Dickinson is recalling BD BBL Sensi Disc Minocycline test discs due to potential accuracy and quality control failures that may cause delayed test results, missed diagnoses, or inappropriate antibiotic selection.
Wegmans Food Markets recalls 9 oz 10-pack Assorted Mini Danish pastries (UPC 7789050815) because the product contains undeclared soy lecithin, which poses a risk to consumers with soy allergies.
Greco Sidari is recalling fresh bocconcini mozzarella cheese distributed across three states because it was not held at appropriate temperatures. Improper storage could lead to spoilage and potentially support pathogen growth.
BD BBL Sensi Disc Cefotaxime susceptibility testing discs may produce inaccurate results for H. influenzae, potentially leading to delayed diagnosis and inappropriate antibiotic selection. The FDA has recalled 2,363,168 units distributed domestically and internationally.
Angiodynamics is recalling PulseSpray Infusion System devices due to a manufacturing defect in the rotating adaptor O-ring that may compromise seal integrity and cause medication to leak during infusion.
The Flow-e Anesthesia System model 6887900 is recalled due to a cybersecurity vulnerability that could allow remote access, denial of service, or code execution, potentially affecting anesthesia delivery safety.
BD BBL Sensi Disc Ertapenem test discs are being recalled due to reproducibility and accuracy failures that may cause diagnostic errors, delayed diagnosis, or inappropriate antibiotic selection.
OMEZA LLC has recalled Omeza Lidocaine Lavage pain relief oil (4,390 vials) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily on January 19, 2024.
Becton Dickinson is recalling 2.3 million antibiotic susceptibility testing discs due to accuracy and quality control failures. The discs may cause delayed or incorrect test results, potentially leading to inappropriate antibiotic selection.
Globus Medical is recalling Cranial Drills due to potential sterility loss from packaging breaches and discoloration at the drill tip. The drills are used in cranial surgery with the ExcelsiusGPS system.
BD BBL Sensi Disc Moxifloxacin test discs are recalled due to possible failures in antibiotic susceptibility testing accuracy. Test failures could lead to delayed diagnosis or inappropriate antibiotic selection.