Check a product

American Health Packaging distributed buprenorphine sublingual tablets with incorrect labeling. The affected medication is a prescription opioid used to treat pain and opioid use disorder. A label mix-up could result in dosing errors if patients or healthcare providers rely on incorrect information.

Moderate·FDA·Sep 9, 2026·American Health Packaging

Mylan Pharmaceuticals is recalling Prasugrel 10mg tablets (Lot #3225272, expiring September 30, 2026) because they failed dissolution testing during 18-month stability studies. This means the tablets may not break down and release the medication as intended in the body. No injuries have been reported.

Moderate·FDA·Sep 9, 2026

Chiesi USA, Inc. is recalling Revcovi (elapegademase-lvlr) Injection due to out-of-specification stability results in the protein concentration profile. The affected lot was distributed to Missouri and Tennessee. No injuries have been reported.

Moderate·FDA·Sep 9, 2026

Sage Products is recalling specific lots of 2% Chlorhexidine Gluconate non-sterile cloths due to potential cross-contamination with other products during manufacturing. The affected cloths may not meet safety and quality standards. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Sage Products

Teva Pharmaceuticals discovered that some bottles of trazodone 50 mg tablets contain foreign tablets or capsules mixed in with the correct medication. The issue affects one lot (1394026) with an expiration date of February 2028. No injuries have been reported.

Moderate·FDA·Sep 9, 2026

Supernus Pharmaceuticals is recalling one lot of Trokendi XR (topiramate) 50 mg extended-release capsules because the medication did not dissolve as designed. When a medication fails to dissolve properly, the body may not absorb the full dose, potentially reducing its effectiveness.

Moderate·FDA·Sep 9, 2026·Supernus

Mylan Pharmaceuticals is recalling specific lots of Mycophenolate Mofetil for injection (500 mg/vial) because the medication failed to meet dissolution specifications—meaning the drug may not dissolve properly in the body. This could affect how well the medicine works. The recall affects two lots distributed nationwide.

Moderate·FDA·Sep 9, 2026

The FDA recall covers two Broadway Joe's pain creams containing CBD and hempseed oil, sold in 2 oz and 4 oz jars. The recall was made because of possible contamination of a raw material, found through manufacturing quality issues. The products were distributed in Colorado, and no injuries have been reported.

Moderate·FDA·Sep 9, 2026·Lexia2 products

Allies is recalling four sizes of THE ONE SPF 50 Invisible Sunscreen Gel, sold as 3 mL sachets, 20 mL, 50 mL and 90 mL tubes. Testing found the product may not reliably provide the SPF 50 protection stated on the label. No injuries have been reported.

Moderate·FDA·Sep 9, 2026·Allies4 products

Bionpharma Inc. is recalling Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets (10 mg/10 mg, 100-count bottles) because some bottles contain unidentified foreign tablets or capsules mixed in with the correct medication. The affected lot is DMA25006 with an expiration date of 11/30/2028. This issue was discovered during quality control.

Moderate·FDA·Sep 9, 2026·Bionpharma

Baxter is recalling 17 intravenous (IV) drug products for manufacturing quality problems, called CGMP deviations, which are lapses in the required production standards. The products include vancomycin, daptomycin, clindamycin, famotidine, dexmedetomidine, vasopressin, pantoprazole, insulin, nicardipine, and amiodarone, plus the brand names Myxredlin, CARDENE IV, and Nexterone. They were distributed nationwide, in Puerto Rico, and in Chile, and no injuries have been reported.

Moderate·FDA·Sep 9, 202617 products

Golden State Medical Supply Inc. is recalling Prasugrel HCI 10mg tablets (lot GS062298, expiration 09/30/2026) because they failed to meet dissolution specifications during quality testing. Dissolution is how quickly a tablet breaks down in the body to release its active ingredient. Tablets that dissolve too slowly or incompletely may not work as intended.

Moderate·FDA·Sep 9, 20262 products

A software update to GE's Portrait Compute and Core Services system may cause patient monitoring to stop working at the Hub and Central Viewer. The update can also reset all alarm settings back to factory defaults, overriding the alarm configurations that were previously set up for individual patients or care areas.

Moderate·FDA·Sep 2, 20264 products

Olympus Corporation of the Americas is recalling POWERSEAL 5mm curved jaw sealer and divider devices due to incorrect labeling on the outer box. Some units labeled as 37 cm devices actually contain 23 cm devices, which could lead to confusion during surgical use. The issue affects 335 units distributed in the US, Australia, the European Union, and Japan.

Moderate·FDA·Sep 2, 2026

Healthmark Industries is recalling two ProChek protein test products, 5,143 units in total. The tests were made with an expired ingredient, so they may give false negative or false positive results. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Healthmark Industries2 products

FUJIFILM Synapse PACS software version 7.4.310, used in radiological imaging systems, has a software issue that can cause the ruler measurement tool to display inaccurate values. This affects 6 units distributed across select US states and Australia. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Fujifilm

Medline is recalling 11 groups of surgical convenience kits. The kits contain a component that the manufacturer recalled because it may be contaminated. No injuries have been reported, and the kits were distributed in 18 states.

Moderate·FDA·Sep 2, 202611 products

Some ConMed Linvatec GENESYS CrossFT Suture Anchors (REF# CFBC-5502B, Lot 1513167) may contain an incorrect patient implant card. This card is used to identify and track the device after implantation, so an incorrect card could lead to confusion about which device was used.

Moderate·FDA·Sep 2, 2026·ConMed

Fresenius Medical Care has identified a problem with certain 2008T BlueStar hemodialysis machines that can cause flow, water supply, or temperature alarms to malfunction. These alarms are important safety features that alert clinical staff to problems during treatment. About 1,140 affected machines have been identified by serial number.

Moderate·FDA·Sep 2, 2026

Henry Schein is recalling two dental restorative products, Structur 2 SC Temporary Resin Cartridge Refill and Grandio Universal Nano-Hybrid Restorative Material Capsules, with 974 units affected. Specific lots were distributed in the U.S. and Barbados with incorrect packaging and Instructions for Use from the FDA-cleared device.

Moderate·FDA·Sep 2, 2026·Henry Schein2 products

Fixing screws on the ceiling movement gear of the suspended arm in Canon Medical Alphenix interventional X-ray systems may become loose over time. This could potentially cause the arm to shift during use. Ten systems are affected across eight U.S. states.

Moderate·FDA·Sep 2, 2026

Midmark is recalling two digital electrocardiogram (ECG) products, including the IQecg Digital ECG and the Digital ECG HD+12 and HD+15, because a communication anomaly may cause incorrect heart waveforms and an inaccurate beats-per-minute reading. The recall covers software versions of the IQecg Plugin starting with v10 and before v10.1.0.18. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Midmark2 products

AVID Medical is recalling seven Halyard medical kit products because the labeling does not disclose that the StatLock component contains natural rubber latex. The kits were distributed nationwide, including in Mississippi and Texas. No injuries have been reported.

Moderate·FDA·Sep 2, 20267 products

Merge Healthcare's PACS and OrthoPACS medical imaging workstations contain a software issue that may cause measurements to be displayed inaccurately. Version 9.5 is affected. The issue was identified in 20 units distributed across California, Florida, Kentucky, Nebraska, and Washington.

Moderate·FDA·Sep 2, 2026·Merge Healthcare

American Contract Systems is recalling 4 convenience kit models that contain Medline Red Rubber Intermittent Catheters. Medline found that representative samples did not meet applicable performance specifications. The kits were distributed in Iowa and Ohio, and no injuries have been reported.

Moderate·FDA·Sep 2, 20264 products

Medline Industries distributed 45 tracheostomy tube kits (SKU DYKM2330) with incorrect component labeling. The discrepancy between the kit label and its contents could lead to confusion during use. No injuries have been reported.

Moderate·FDA·Sep 2, 2026

Hollister has identified a manufacturing defect in select lots of Onli Hydrophilic Urethral Intermittent Catheters that may cause a protrusion on the catheter tip. This defect could lead to genitourinary trauma or bleeding during use.

Moderate·FDA·Sep 2, 2026·Hollister

Medline is recalling specific lots of its medical convenience kits that contain Pilling Wecksorb Neurosponges and Neurosponge Strips. The neurosponges may have endotoxin levels above specification. The recall covers four product groups, about 6,950 kits in total, distributed in several US states. No injuries have been reported.

Moderate·FDA·Sep 2, 20264 products

Philips Incisive CT scanners running software versions V4.5 or V5.0 may fail to start a clinical scan during Bolus Tracking imaging procedures. This could delay or prevent necessary diagnostic scans from being acquired.

Moderate·FDA·Sep 2, 2026

Hikma Pharmaceuticals is recalling specific lots of Ramipril Capsules 10 mg because testing found higher-than-allowed levels of dicyclohexylurea, a process impurity. The affected lots are AC5470A and AC5470B, both expiring July 2027. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Hikma Pharmaceuticals