Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Minimum severity
Teva Pharmaceuticals is recalling Isotretinoin 30 mg capsules with potency defects. Affected lots contain capsules that are either superpotent or subpotent from normal specifications.
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.
Cook Medical issued a Class II recall of 318 Wayne Pneumothorax Trays distributed worldwide because the devices were labeled with expiration dates exceeding their true shelf life.
Beckman Coulter is recalling MicroScan Neg Multidrug Resistant test kits due to incorrect manufacturing processing of the in vitro antimicrobial test. The defect may affect diagnostic accuracy.
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.
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.
Fagron Compounding Services is recalling Vancomycin HCI injections nationwide due to lack of sterility assurance and potential detachment of a break-off-part from the administration port. Affected healthcare facilities should refer to FDA guidance.
The FDA is recalling Vancomycin HCI injectable solution (34,260 bags) distributed nationwide due to lack of sterility assurance and risk of a blue break-off-part detaching from the administration port.
Fresenius Kabi recalled specific batches of 0.9% sodium chloride injection because sterility cannot be assured. The affected batches were distributed throughout the United States, Alaska, and Puerto Rico.
Viatris Inc. recalls Xanax XR (alprazolam) 3 mg extended-release tablets due to failed dissolution specifications. Affected lot 8177156 (exp. 02/28/2027) was distributed nationwide.
Fagron Compounding Services is recalling norepinephrine bitartrate injection nationwide due to lack of sterility assurance and a blue break-off part that could detach from the administration port.
Fagron Compounding Services is recalling 5,140 bags of norepinephrine injectable nationwide due to lack of sterility assurance and a potentially detachable component in the administration port. The affected lots expire between April and July 2026.
Fresenius Kabi USA is recalling a batch of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The product was distributed nationwide, in Alaska, and Puerto Rico.
Fagron Compounding Services is recalling Vancomycin HCL injectable solutions due to lack of sterility assurance and risk that a blue break-off part could detach from the administration port.
Cook Incorporated is recalling certain COOK Spectrum Central Venous Trays that are labeled with expiration dates exceeding their actual shelf life, creating risks of compromised sterility and device degradation.
Beckman Coulter is recalling MicroScan Neg MIC 3J diagnostic panels due to manufacturing errors affecting test accuracy. One well per panel is missing a required drug while others contain double the intended amount of antibiotics.
Tornier HRS Max orthopedic implant parts were mislabeled as compatible with the HRS Max system, but are actually compatible only with the older HRS system and will not work with HRS Max components.
ARTIS pheno and ARTIS Icono X-ray systems may display dramatically higher radiation dose readings than actually applied during patient examinations. The actual dose remains compliant with regulations, though the display error could lead clinicians to question equipment accuracy.
Cook Medical has recalled 916 units of Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets worldwide because the labels show expiration dates that exceed the true shelf life of the devices.
Spacelabs Multi-parameter Command Module Model 91496 may provide inaccurate cardiac measurements in Auto mode due to a circuit board defect, potentially delaying diagnosis and increasing risk of fluid overload.
Cook Incorporated is recalling 95 Cook Staged Extubation Sets worldwide because the devices are labeled with expiration dates that exceed their actual shelf life. Using an expired device could compromise its sterility and safety.
Cook Incorporated recalled 1,872 Cook Spectrum Central Venous Catheter Trays with incorrect expiration date labeling. Products were labeled with expiration dates exceeding their true shelf life.
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.