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.
Zydus Pharmaceuticals is recalling Estradiol Transdermal System patches nationwide due to failed impurities and degradation specifications. The recall affects 21,360 units distributed throughout the United States.
LEICA BIOSYSTEMS is recalling 141 Leica HistoCore PEGASUS tissue processors due to reagent overfilling that causes poorly processed or damaged biopsy tissue specimens.
Rising Pharma's pregabalin capsules are being recalled nationwide after a pantoprazole tablet was discovered during packaging. No illnesses have been reported.
Bryant Ranch Prepack is recalling Cephalexin oral suspension (125mg/5mL) due to back label errors stating the dose as 2.5g instead of the correct 5g per bottle. No illnesses have been reported.
The O-arm O2 surgical imaging system may experience intermittent electrical failure affecting intraoperative imaging guidance. The recall involves 20 units distributed in the US and internationally.
Bryant Ranch Prepack is recalling 61 bottles of Cephalexin for Oral Suspension due to a back label stating an incorrect dose amount—5g instead of 10g per bottle.
Bryant Ranch Prepack is recalling Cephalexin oral suspension because the back label incorrectly states the bottle contains 5g instead of 10g. No illnesses have been reported.
GlaxoSmithKline recalls TIVICAY cartons nationwide with incorrect expiration date on packaging. The carton label shows May 2026, but the correct expiration on the bottle is April 2025.
Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Range Verifier Lot 1200 because the product may fail to verify required calibration range. The failure is detectable during use and does not affect actual patient test results.
Zydus Pharmaceuticals is recalling 13,440 units of Estradiol transdermal patches distributed nationwide due to failed impurities and degradation specifications. No illnesses or injuries have been reported.
Charles Boggini Pink Lemonade in 1 and 5-gallon sizes is recalled for containing undeclared FD&C Red No. 40. The colorant was not listed on product labels.
Cephalexin for Oral Suspension is being recalled due to a back label error. The label states 'Each contains' instead of 'Each Bottle contains,' affecting 190 bottles distributed nationwide.
Bryant Ranch Prepack is recalling Cephalexin oral suspension bottles due to incorrect labeling that states tablet information instead of liquid suspension details and omits the total dose per bottle.
Revive Rx Pharmacy recalls 751 vials of compounded tirzepatide (Lot #748127) labeled to contain tirzepatide but actually filled with testosterone cypionate. Patients receiving this medication may take the wrong drug with serious health consequences.
Medline endotracheal tubes with subglottic suctioning may have inflation tubes that detach or tear and suction pumps that disconnect, risking loss of ventilation control.
Gibson Farms Organic Nuts – Light Halves and Pieces are recalled due to potential E. coli O157:H7 contamination. Affected lots 3325-043 and 3341-501 were distributed to California and Washington.
Hy-Vee Stores Inc is recalling Hy-Vee To Go and Hy-Vee Cookies & Cream Mix products due to potential Salmonella contamination. Affected products were distributed in eight Midwest states.
Maribel's Sweets, Inc. is recalling 4,011 boxes of 6-piece signature ganache chocolate boxes due to undeclared coconut. Consumers with coconut allergies are at risk.
The BD Pyxis MedStation 4000 Auxiliary Tower may allow fluid to enter the system, potentially causing smoke, system downtime, and fire. The FDA Class II recall affects 35,029 units distributed worldwide.
Philips is recalling Allura Xper FD10 medical imaging systems with software version 8.1.100 because the pivot brake may fail to engage, potentially causing unexpected table movements during procedures.
Genentech is recalling Cathflo Activase injection vials in two lots due to deformed stoppers found during manufacturing that compromise sterility assurance.
ARG Laboratories is recalling Pain Wizard pain relief cream due to propylene glycol used in manufacturing not meeting pharmaceutical grade specifications. The product was distributed nationwide.
Maribel's Sweets, Inc. is recalling Mother's Day heart ganache boxes because they contain undeclared coconut, an allergen not listed on the label. This poses a risk to consumers with tree nut allergies.
The FDA is recalling the Mirion Captus 4000e Thyroid Uptake System due to reports of unexpected collimator detachment that could affect diagnostic accuracy. Approximately 1,275 units are affected worldwide.
Rubicon Research is recalling 11,664 bottles of Metoprolol Tartrate 25mg tablets nationwide due to the presence of metal in the tablets. Consumers should discontinue use and contact their healthcare provider.