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.
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheaths are being recalled because the carton label does not match the inner pouch label. No illnesses or injuries have been reported.
Preferred Pharmaceuticals recalls Glimepiride Tablets, 2 mg, 90-count bottles due to manufacturing process deviations discovered during FDA inspection. No illnesses have been reported.
Preferred Pharmaceuticals is recalling 32 bottles of Tadalafil 20 mg tablets due to manufacturing process deviations identified during FDA inspection. The recalled lots expire January 31, 2024.
Accord Healthcare recalled 4,574 cartons of Cyanocobalamin injection (Lot R2200394) nationwide after testing showed the drug was sub-potent and failed to meet strength specifications.
Preferred Pharmaceuticals is recalling Atorvastatin Calcium Tablets (10 mg) distributed nationwide due to manufacturing process deviations identified at Accord Healthcare. Affected lot numbers are A0523D, F14220, and J0622Q.
RemedyRepack Inc. is recalling Simvastatin 40 mg tablets nationwide due to manufacturing deviations. The voluntary recall was initiated in March 2023.
Preferred Pharmaceuticals is recalling specific lots of Finasteride Tablets, 5 mg due to manufacturing process deviations discovered during FDA inspection of manufacturer Accord Healthcare. No illnesses or injuries have been reported.
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 20 mg, in three package sizes due to manufacturing process deviations at Accord Healthcare. The affected tablets were distributed nationwide.
RemedyRepack Inc. is recalling 399 bottles of Rosuvastatin 5mg tablets nationwide due to manufacturing deviations. No illnesses have been reported.
Direct Rx is recalling Alprazolam C-IV 2 mg tablets (NDC 72189-121-60) due to potential cross-contamination at the manufacturer. Nine bottles distributed nationwide; affected lots include 03FE2319 and 13MY2217.
Preferred Pharmaceuticals, Inc. is recalling Rosuvastatin Calcium 10 mg tablets nationwide due to cGMP deviations identified during FDA inspection of the manufacturing facility.
Preferred Pharmaceuticals recalls Doxazosin Tablets USP 2 mg (Lot H3122K, expires 5/31/2024) due to current Good Manufacturing Practice deviations identified at the manufacturing facility.
Preferred Pharmaceuticals is recalling Doxazosin Tablets, USP, 4 mg (lot L1522V, expiration 4/30/2025) due to current Good Manufacturing Practice deviations discovered during FDA inspection of the manufacturer, Accord Healthcare. The product was distributed nationwide.
Direct Rx is recalling Alprazolam 1 mg tablets nationwide due to potential cross contamination at the manufacturer. No illnesses or injuries have been reported.
Wismettac Asian Foods is recalling Shirakiku Furikake Seasoned Roasted Seaweed Flakes Spicy due to incorrect crustacean labeling. The company distributed 17,517 packages across 22 states.
SSS brand and K-Fresh branded enoki mushrooms are being recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the affected product.
THE ISH COMPANY is recalling 355 ISH Shrimpish Sample Meal Kits distributed to multiple states throughout 2022 for undeclared soy protein that may cause allergic reactions in sensitive consumers.
Lemonland Food Corp has recalled Stir-Fried Anchovy products distributed in Washington due to undeclared allergens: wheat, soybean, fish, and sesame. Consumers with allergies to these ingredients should not consume the product.
Ascend Laboratories is recalling 12,804 bottles of Dabigatran Etexilate 150mg capsules nationwide due to detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake limit caused by manufacturing process deviations.
Lemonland Food Corp is recalling Seasoned Dried Pollack distributed in Washington for undeclared Fish, Wheat, and Soybean allergens. Consumers with these allergies should not consume this product.
Ascend Laboratories is recalling 13,560 bottles of Dabigatran Etexilate 75 mg capsules nationwide because testing detected N-nitroso-dabigatran impurity levels above acceptable limits. The issue stems from a manufacturing quality control deviation.
Siemens ARTIS pheno X-ray systems may experience unintended table movement that the system fails to detect, risking injury to patients, staff, or operators. The FDA is recalling 141 affected units nationwide.
Lemonland Food Corp recalled seasoned nut products for undeclared peanut and walnut allergens. Consumers with allergies to these nuts should not consume affected products sold in Washington between February 16-23, 2023.
Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL Elite/Elite Pro Analyzers. This affects 358 units in the US and 558 units internationally.
Lemonland Food Corp has recalled Radish Kimchi distributed in Washington due to undeclared fish (anchovy, sardinella) and shrimp. Consumers with allergies to fish or shellfish should not consume this product.