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.
Beckman Coulter is recalling MicroScan Neg MIC 3J panels because a manufacturing issue left one well missing a drug while containing double the amount of antibiotics.
Cook Medical is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 916 units are affected.
Fagron is recalling norepinephrine bitartrate 32 mg in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.
Cook Medical is recalling Wayne Pneumothorax Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 104 units are affected.
Fresenius Kabi is recalling 5% Dextrose Injection, USP, 2.5 g per 50 mL supplied in 100 mL freeflex bags, citing lack of assurance of sterility.
B.R.A.H.M.S PlGF Plus KRYPTOR in vitro diagnostic tests are being recalled after customers observed out-of-range values at the lowest quality control level, which can contribute to falsely elevated results.
Stryker Sustainability Solutions is recalling Color Cuff tourniquet cuffs because the cuff can detach from the bladder at the welding connection, leaving it unable to maintain pressure.
F&S Fresh Foods is recalling ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich because the sandwich contains visible sesame but the label does not declare sesame, posing a risk to consumers with sesame allergies.
Zarlengo Italian Ice is recalling Zarlengo's Double Dark Chocolate Gelato in 1-gallon buckets because soy lecithin is listed in the ingredients but soy is not disclosed in the allergen statement, posing a risk to consumers with soy allergies.
Riverence Smoked Trout Dip is being recalled because the label declares cream cheese in the ingredients but does not declare milk. 306 cases, or 3,672 units, are affected.
Tornier HRS Max tuberosity bodies and a trial component were incorrectly labeled as HRS Max products; they are compatible only with the Tornier HRS system. 233 units are affected.
Cook Medical is recalling Arterial Pressure Monitoring Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.
Cipla is recalling Lanreotide Injection 120 mg/0.5 mL prefilled syringes for lack of assurance of sterility, following an FDA observation of deficiencies in visual inspection at the contract manufacturing site.
Preferred Pharmaceuticals is recalling six lots of Artificial Tears Lubricant Eye Drops manufactured by Geri-Care, citing lack of assurance of sterility. 720 bottles are affected.
Fresenius Kabi is recalling one batch of 0.9% Sodium Chloride Injection, USP in 1,000 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.
Zarlengo's Chocolate Gelato is being recalled because soy lecithin appears in the ingredients statement but soy is not declared in the contains statement.
Viatris is recalling one lot of Xanax XR (alprazolam) extended-release tablets, 3 mg, after the product failed dissolution specifications.
Cook Medical is recalling a Multipurpose Drainage Catheter because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.
Teva is recalling three lots of Isotretinoin Capsules, USP, 30 mg because the product was found to be superpotent and subpotent. 21,984 packages are affected.
Blueroot Health, Inc. is recalling Vital Nutrients Aller-C vitamin supplements because they contain undeclared egg, soy, and hazelnut allergens, posing a risk to consumers with allergies to these ingredients.
Xtant Medical is recalling Xpress Pedicle Screw System dual lead screws from one lot that were mislabeled with a part number identifying them as shorter than they physically are.
Fagron is recalling norepinephrine bitartrate 16 mg in 250 mL sodium chloride bags for lack of assurance of sterility and because a blue break-off part could detach from the administration port.
GE Healthcare is recalling Omnipaque (iohexol) Injection, 300 mg/mL, over the presence of particulate matter. The action covers 866,570 vials distributed nationwide.
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 50 mL presentation distributed by BD, citing lack of assurance of sterility.
Cook Medical is recalling Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 484 units are affected.