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.
Fresenius Kabi USA, LLC is recalling batch 6402413 of 0.45% Sodium Chloride Injection, USP, due to lack of assurance of sterility. The affected batch was distributed nationwide, including Alaska and Puerto Rico.
Cook Medical is recalling certain NCompass Nitinol Stone Extractor units with expiration dates exceeding true shelf life. Affected healthcare providers should discontinue use and contact the manufacturer.
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.
Zarlengo Italian Ice is recalling Chocolate Chocolate Chip Gelato in multiple sizes because soy lecithin is listed in the ingredients but soy is not declared in the allergen statement, posing a risk to consumers with soy allergies.
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.
Zarlengo's Chocolate Gelato is recalled because soy lecithin is in the product but soy is not listed in the allergen contains statement. The mislabeling affects people with soy allergies.
Teva Pharmaceuticals is recalling Isotretinoin 30 mg capsules with potency defects. Affected lots contain capsules that are either superpotent or subpotent from normal specifications.
Teva Pharmaceuticals is recalling approximately 62,136 cartons of clonidine transdermal patches (0.2 mg/day) distributed in the U.S. due to manufacturing deviations involving use of an unapproved raw material.
Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection because sterility cannot be assured. The affected batches were distributed nationwide, including Alaska and Puerto Rico.
Fresenius Kabi recalls 0.9% Sodium Chloride Injection due to lack of sterility assurance. Multiple batches distributed nationwide are affected; patients should contact their healthcare provider.
GE Healthcare is recalling OMNIPAQUE (iohexol) injection vials nationwide due to presence of particulate matter. The affected lots are distributed throughout the U.S.
Cipla USA recalls Lanreotide Acetate Injection nationwide due to manufacturing deficiencies in visual inspection procedures affecting sterile assurance. No illnesses have been reported.
Fresenius Kabi is recalling 5% Dextrose Injection due to lack of assurance of sterility. The affected batch was distributed nationwide in the US, including Alaska and Puerto Rico.
Teva Pharmaceuticals is recalling Clonidine Transdermal System patches (0.3 mg/day) due to use of an unapproved raw material in manufacturing. Approximately 113,943 cartons were distributed in the United States.
Fresenius Kabi USA is recalling batch 6402165 of 5% Dextrose Injection (NDC 65219-458-05/30) due to lack of assurance of sterility. The batch was distributed nationwide through May 30, 2028 and should not be used.
Fresenius Kabi is recalling specific batches of 5% Dextrose Injection due to lack of assurance of sterility. The affected batches were distributed nationwide, including Alaska and Puerto Rico.
Fresenius Kabi USA, LLC is recalling multiple batches of 0.9% sodium chloride intravenous injection due to lack of sterility assurance. No illnesses have been reported, but non-sterile IV solutions pose a risk of serious infection.
Fresenius Kabi USA, LLC is recalling sodium chloride 0.9% intravenous injections because the manufacturer cannot assure sterility. Affected batches were distributed nationwide and in Puerto Rico and Alaska.
Cook Medical is recalling the Approach CTO-18 Micro Wire Guide due to mislabeled expiration dates that exceed the product's actual shelf life. The recall affects 75 units distributed worldwide.
Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection due to lack of sterility assurance. The affected intravenous medication was distributed nationwide, including Alaska and Puerto Rico.
Fresenius Kabi USA is recalling specific batches of 0.9% sodium chloride injection due to lack of assurance of sterility. The product is distributed nationwide, Alaska, and Puerto Rico.
Teva Pharmaceuticals is recalling Isotretinoin 40 mg capsules in specific lots due to potency variation issues, affecting 8,376 packages distributed to FL, OH, PR, and MS.
Fresenius Kabi USA, LLC is recalling specific batches of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. Patients who have this product should contact their healthcare provider.
GE Healthcare is recalling OMNIPAQUE (iohexol) radiographic contrast injection nationwide due to the presence of particulate matter in certain lots. The recall affects 866,570 vials.