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.
Bel Gioioso cheese was not held at appropriate temperatures during distribution, potentially allowing spoilage and pathogen growth. Consumers should not consume affected product.
Greco Sidari's ricotta cheese was not held at appropriate temperatures, which could affect food spoilage and potentially support pathogen growth. The recall affects 1375 cases distributed in OH, NY, and PA.
Globus Medical is recalling Cranial Drill 6.00mm units due to potential packaging breaches that may render the sterile product non-sterile, and discoloration near the drill tip.
Becton Dickinson is recalling BD BBL Sensi Disc Meropenem antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed or incorrect diagnostic results.
Greco Sidari is recalling Grande Prima Dolce Ricotta due to improper temperature storage that could allow pathogen growth. The recall affects 1,375 cases distributed to Ohio, New York, and Pennsylvania.
Greco Sidari is recalling GRANDE fresh bocconcini mozzarella because the product was not held at appropriate temperatures during storage. The temperature failure could allow spoilage and pathogen growth.
Greco Sidari is recalling Bellissimo Mascarpone (1375 cases) distributed to OH, NY, and PA due to improper temperature storage that could allow spoilage and pathogenic growth.
Becton Dickinson is recalling BD BBL Sensi Disc Azithromycin test discs due to potential accuracy and quality control failures that may delay diagnosis or result in inappropriate antibiotic selection.
Becton Dickinson is recalling BD BBL Sensi Disc Ampicillin antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed diagnosis or inappropriate antibiotic selection.
BD BBL Sensi Disc Rifampin antibiotic susceptibility test discs are being recalled due to potential accuracy and quality control failures. These discs are distributed domestically nationwide and internationally.
Greco Sidari is recalling 1,375 cases of Bel Gioioso Provolone Sharp cheese distributed in Ohio, New York, and Pennsylvania. The recall is due to improper storage temperature that could support pathogen growth.
Greco Sidari is recalling Norpaco Sweetie Pepper Goat Cheese (1,375 cases, 1/5# units) distributed in Ohio, New York, and Pennsylvania. The cheese was not held at appropriate temperatures, which could support pathogen growth.
Amerisource Health Services LLC is recalling approximately 1,932 cartons of Febuxostat (40 mg tablets) nationwide due to deviations from current good manufacturing practices. The firm initiated the recall voluntarily on January 25, 2024.
Greco Sidari is recalling President Goat Cheese (1375 cases) distributed in Ohio, New York, and Pennsylvania between November 26, 2023 and January 5, 2024 due to improper storage temperature that could support pathogen growth.
Dr. Reddy's Laboratories is recalling Glimepiride 1mg tablets due to a misprint on the tablet. The recall affects 59,336 bottles distributed nationwide.
Dr. Reddy's Laboratories is recalling Glimepiride 1mg tablets nationwide due to a printing defect on the tablet. The voluntary recall affects 14,425 bottles.
County Fair Foods is recalling 42,000 bags of Popcorn Pre-Pop nationwide due to undeclared Yellow #5 dye. The voluntary recall was initiated because Yellow #5 was not declared on the product label.
Maquet Medical Systems is recalling the Bubble Sensor accessory for CARDIOHELP-i extracorporeal life support systems due to an incorrect UDI Device Identifier printed on the product label.
Medline Remedy Clinical antifungal cream is recalled for labeling that falsely claims to be paraben-free while the product actually contains parabens. About 1,786 tubes nationwide are affected.
Fujifilm is recalling sperm separation media kits because the lower layer component may not match the documented lot. The kits may contain an older component with a different shelf life, which could affect product performance.
Now Foods has recalled Phosphatidyl Serine 300mg softgels due to lower actual ingredient content than labeled. The recall affects 12,051 bottles distributed nationwide and internationally.
Amerisource Health Services is recalling HydrALAZINE Hydrochloride Tablets (10 mg) due to failed impurity specifications discovered during 6-month stability testing.
Olympus Corporation of the Americas is recalling one lot of Paparella-Type Vent Tubes due to missing expiration date on the inner package, though the date is present on the outer packaging.
Galbani Domestic Mascarpone (1/5# cases) distributed in Ohio, New York, and Pennsylvania is recalled due to improper temperature storage. The temperature control failure could affect product spoilage and potentially support pathogen growth.
Denver Solutions is recalling 29,016 Phenylephrine HCl IV bags distributed nationwide. A filling system malfunction can result in some bags receiving double doses of this potent injectable drug.