1,894 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.
Looking for a specific drug? Use the search page to find recalls by medication name, manufacturer, or NDC number.
Sato Pharmaceutical Co., Ltd. recalled 3,640 bottles of INON ACE Antacid tablets on December 19, 2025. The recall follows failed disintegration specifications, indicating the tablets may not dissolve properly. Consumers should stop using the product immediately and seek guidance from healthcare providers.
MicroPort Orthopedics recalled 91 units of the HIPTURN Fem Head Trial 36mm Reusable device on December 19, 2025. The recall follows the lack of FDA premarket authorization for distribution in the United States. The affected devices were distributed across multiple states and several countries, posing a potential health risk to patients and healthcare providers.
Canon Medical System, USA recalled 98 units of its Alphenix INFX-8000F X-ray system on December 19, 2025. Loose fixing screws in the ceiling movement gear may cause malfunction and abnormal noise. Healthcare providers should stop using the system immediately and follow recall instructions.
Canon Medical System, USA recalled 3 interventional fluoroscopic x-ray systems on December 19, 2025. The recall follows reports that fixing screws in the ceiling movement gear may become loose, causing operational failures. Users should stop using the device immediately and follow provided instructions.
Canon Medical System, USA recalled 332 units of the Alphenix INFX-8000V X-ray system on December 19, 2025. Loose fixing screws may hinder ceiling movement and cause sensor errors. Healthcare providers must stop using the device immediately and follow manufacturer's instructions.
Canon Medical Systems recalled 34 MRI systems due to a risk of helium gas release. The recall affects models MRT-3020 and MEXL-3020 distributed across 13 states. Healthcare providers should stop using these devices immediately and follow recall instructions.
Bisaf Strep A Self-Test from Altruan GmbH remains active in recall status after the FDA flagged lack of clearance. The Class II medical device was distributed nationwide in the United States. The hazard is lack of FDA clearance. Consumers should stop use immediately and follow manufacturer guidance.
Siemens Medical Solutions USA, Inc. recalled 88 units of NAEOTOM Alpha software applications on December 19, 2025. The applications lack FDA 510(k) clearance, posing potential risks to patient safety. Healthcare providers must stop using the software immediately and follow the manufacturer's instructions.
Tyber Medical recalled 64 units of the VOLT Wrist Treatment System on December 19, 2025. The recall affects model number 02.426.691S due to incorrect thread orientation in anatomical left plates. Patients and healthcare providers should stop using this device immediately.
Altruan GmbH recalled 188 units of the Clearest Strep-A Cassette Test distributed nationwide in the United States after determining the device was not cleared by the FDA. The test lacks FDA clearance. Healthcare providers and patients should stop using the test immediately and follow the manufacturer’s recall instructions.
Canon Medical Systems recalled 22 MRI systems on December 19, 2025, due to a potential ice formation hazard in the venting system. The defect could lead to a pressure build-up and helium gas release. Healthcare providers must stop using the affected devices immediately.
ICU Medical has recalled over 14 million needle-free access devices after reports of fluid leaks and potential exposure to biological contaminants. The recall affects devices distributed worldwide, including in 50 states and multiple countries. Users must stop using these devices immediately and follow recall instructions from the manufacturer.
Canon Medical System, USA recalled 172 Alphenix INFX-8000C x-ray systems on December 19, 2025, due to loose screws in the ceiling movement gear. This defect can lead to loss of lateral movement, abnormal noise, and sensor errors. Healthcare providers must stop using the device immediately.
ICU Medical recalled 64,290 Pulsator Arterial Blood Sampling Kits due to a potential crack in the syringe collar. This defect may cause blood leakage and delayed sampling. The recall affects models sold nationwide since December 2025.
Boston Scientific recalled 557 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. Increased reports of stent deployment and expansion issues prompted this recall. The defect may require additional medical intervention to resolve deployment failures.
Tornier recalled 427 units of its Perform Reversed Perip Screws on December 19, 2025, due to incorrect labeling. The screws, meant to be 5.0mmx18mm, were misidentified as 5.00mmx14mm. This labeling issue can lead to surgical delays or increased risk of mechanical failure if unnoticed.
Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.
Imprimis NJOF, LLC recalled 314 boxes of Tri-Moxi+¿ intraocular injections on December 18, 2025. The recall is due to the presence of glass-like particles in the product. Consumers and healthcare providers should stop using the product immediately and contact the company for further guidance.
Imprimis NJOF, LLC recalled 596 boxes of intraocular injections on December 18, 2025. The recall affects products due to the presence of glass-like particles. Consumers should stop using the product immediately and contact their healthcare provider.
Rifton Equipment recalled 470 E-Pacer gait training devices on December 18, 2025. The body support strap may fray, posing a risk to users. Health care providers and patients must stop using the device immediately.
Wilson-Cook Medical recalled 153 units of its Bipolar Sphincterotomes on December 18, 2025. A void in the device's material may cause an inappropriate electrical current during use. The recall affects specific models distributed in California, Colorado, Indiana, and North Carolina.
TopHomer recalled pool drain covers on December 18, 2025, due to serious entrapment and drowning hazards. The recall affects 8-inch drain covers sold on Amazon. Consumers should immediately stop using the products and seek refunds.
Imprimis NJOF, LLC recalled 778 boxes of Dexamethasone Moxifloxacin intraocular injection on December 18, 2025. The recall stems from the presence of glass-like particles in the product. Consumers and healthcare providers should stop using the product immediately.
Rifton Equipment recalled 3,238 TRAM powered lift devices on December 18, 2025, due to a risk of fraying body support straps. This recall affects models K310 sold worldwide, including the US, Europe, and Australia. Healthcare providers and patients must stop using the devices immediately to prevent injury.
Receive immediate notifications when medications you care about are recalled. Stay safe with timely FDA drug safety alerts.