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.
Duloxetine Delayed-Release Capsules USP 60 mg for Quallent Pharmaceuticals are being recalled because N-nitroso-duloxetine was present above the FDA recommended interim limit. 1,856 bottles affected.
Lactated Ringer's Injection USP in 1000 mL Excel containers is being recalled for lack of assurance of sterility because of the potential for fluid leakage at one of the weld sites. 74,088 containers affected.
La Michoacana Mango Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 24,228 units are affected.
Whole Wheat Chocolate Croissants sold in California are recalled for undeclared milk and soy from sub-ingredients. The recall covers 351 cases of 144 pieces each.
Soda Biscuit (Rye Flavor), 360 g packages imported by Shang Hao Jia, Inc., is recalled because the label does not declare whole milk powder and wheat. 4,800 units are affected.
Serv-Rite Reduced Sodium Roast Beef Rub in 50 lb units is recalled because it may contain small metal fragments from a contaminated onion powder ingredient. 7,950 pounds are affected.
Sukhi's Classic Curry Indian Curry Sauce, 3 oz, is recalled for potential contamination with metal pieces. The recall covers 1,125 pounds distributed across more than 25 states.
Sukhi's Tikka Masala Curry Paste in 2.5 lb packs is being recalled because of potential contamination with foreign objects, specifically metal pieces. 9,930 pounds are affected.
La Michoacana Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 29,180 units are affected.
Park Street Deli Cinnamon Bun Dessert Dip in 7 oz plastic tubs is recalled nationwide for plastic foreign material. 19,368 retail units are affected.
Custom Tubing Kits under REF K04-00417, K04-00963 and K04-01029 are recalled because high pressure tubing may separate from its connector and trap air that could reach the patient. 2,779 units are affected.
Glenmark Carvedilol Tablets USP, 25 mg, in 500-tablet cartons are recalled nationwide after N-Nitroso Carvedilol Impurity-1 was found above the FDA-recommended limit. 14,976 bottles are affected.
PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 65 40-S, lot 8-4528, are recalled because the screws may be incorrectly labeled. 16 units are affected.
B. Braun 0.9% Sodium Chloride Injection USP, 1000 mL Excel containers, lot J5C919, is recalled for lack of assurance of sterility because of potential fluid leakage at a weld site. 23,100 containers are affected.
Whole Grain Par Baked Jalapeno Cheddar Bagels sold in California are recalled because milk is missing from the Contains statement. The recall covers 192 cases of 72 pieces each.
Access Thyroglobulin assay reagent lot 439163 is recalled because it may generate erroneously high patient results, which could prompt unnecessary imaging or therapy changes. 453 units are affected.
La Michoacana Cookies N Cream Single Serve Paletas, 3.75 oz, are recalled nationwide because the label names cream as an ingredient but does not declare milk as its source. 15,001 units are affected.
Helados Mexico Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 42,488 units are affected.
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze is being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, lot 23121560, are recalled nationwide for low dissolution results. The recall covers 8,568 bottles.
Cheddar Bagels from The Bonami Baking Company, sold in California, are recalled for undeclared wheat and milk from sub-ingredients. The recall covers 6,156 pieces.
Chocolate Croissants sold in California are recalled for undeclared wheat, milk and soy from sub-ingredients, including soy lecithin. The recall covers 21,096 pieces.
Carefree Surgical Specialties Kittner + Tail Large roll gauzes are being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
Glenmark Carvedilol Tablets USP, 12.5 mg, lot 19243202, are recalled nationwide because N-Nitroso Carvedilol I impurity was found above the current Acceptable Intake level. 6,432 bottles are affected.
La Michoacana Rompope Bolis 6-Count 24 oz packs are recalled nationwide because the label lists cream but does not declare milk as its source. 11,274 units are affected.