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.
Pharmacy Innovations is recalling Ethyl Alcohol 95% (5ML vial) Injectable nationwide because FDA inspection revealed insanitary conditions at the manufacturing facility that compromise sterility assurance.
Averys Savory Popcorn is recalling 3,185 units of gourmet popcorn due to undeclared milk, soy, peanuts, tree nuts, and sulfites. Consumers with allergies to these substances should not consume the product.
Pharmacy Innovations is recalling multiple strengths of injectable Prostaglandin E1 nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.
Pharmacy Innovations is recalling nationwide Albuterol 0.083% inhalation solution in 3ML tubes due to insanitary manufacturing facility conditions that compromise sterility assurance.
Pharmacy Innovations is recalling a heparin-lidocaine irrigation solution nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.
Pharmacy Innovations is recalling Injectable Glycerin 72% (15mL vials) nationwide due to lack of sterility assurance discovered during FDA facility inspection.
SunMed is recalling 43,290 AirQ3 Self Pressurizing Intubating Laryngeal Airways due to a sizing discrepancy between device labeling and actual channel dimensions. Clinicians may need to use a smaller-diameter gastric catheter than indicated.
Baxter recalls one ELI 380 electrocardiograph that was shipped to a customer in Texas by mistake on 26 October 2022. The device was intended for a pilot program only.
Nephron Sc Inc recalls approximately 925,920 vials of S2 Racepinephrine Inhalation Solution due to short fill. Affected lots may contain less medication than labeled.
Ascend Laboratories is recalling 6,336 bottles of Metoprolol Succinate Extended-Release Tablets, 50 mg, distributed nationwide and in Puerto Rico, due to failed dissolution specification.
SunMed's Air-Q3 intubating laryngeal airway devices have a discrepancy between the Instructions For Use and the printed text on the device regarding orogastric tube sizes, which could cause confusion when placing gastric catheters.
Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream 0.05% nationwide because stability testing revealed insufficient active ingredient in the affected lot.
OurPharma LLC is recalling 768 cassettes of FentaNYL Citrate injection solution due to underfilled units. The affected product was distributed in Illinois and Missouri.
Future Diagnostics recalled STAT-IntraOperative-Intact-PTH immunoassay kits due to high coefficient of variability in test results. 342 kits were distributed worldwide.
The Cardiosave Rescue Intra-Aortic Balloon Pump may shut down unexpectedly if blood enters the device through a compromised balloon catheter. Approximately 46 units have been distributed worldwide.
Sysco Merchandising and Supply is recalling Greco and Sons Dough Room dough ball products because they contain undeclared milk allergen, which poses a serious risk to milk-allergic consumers.
The Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly when blood enters the device through a compromised balloon catheter during use.
Sysco Merchandising and Supply is recalling Greco and Sons Dough Room Garlic Knots due to undeclared milk allergen. Affected cases were distributed across six states with best-if-used-by dates between December 1, 2022, and June 1, 2023.
Sysco Merchandising and Supply is recalling multiple Greco and Sons Dough Room products distributed in six states due to undeclared milk allergen. Consumers with milk allergies should not consume these products.
Accord Healthcare is recalling Daptomycin for Injection labeled as 350 mg/vial but containing 500 mg/vial vials. The labeling error poses a dosing risk to patients.
Cardiac Assist is issuing a software update for LifeSPARC Controller units that may experience critical failure causing the system to freeze, crash, or lose display functionality. Affected units are identified by specific serial numbers.
Sysco Merchandising and Supply is recalling multiple Greco and Sons frozen dough products because they contain undeclared milk allergen. Consumers with milk allergies should not consume these products.
Sysco is recalling Greco and Sons dough ball products due to undeclared milk allergen. Consumers with milk allergies should not consume these products.
Sysco Merchandising and Supply recalls Greco and Sons dough products containing undeclared milk allergen. Affected products were distributed to food service locations in six states.
Sun Sprouts Alfalfa Sprouts packaged in 4 oz clamshells and 2.5 lb boxes have been recalled due to potential Salmonella contamination. The affected products were sold to distributors and retailers in Nebraska, Kansas, and Iowa.