1,817 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.
Haleon US Holdings recalls 46,692 toothpaste tubes nationwide after a labeling mix-up. The outer carton says Fresh Mint, while the tube is labeled Cool Mint/Whitening; the tube contents are Fresh Mint as carton indicates. Consumers should stop using the product and contact Haleon for guidance.
Boston Scientific recalled 1,369 Encore 26 Inflation Devices used with balloon dilation catheters after an internal investigation found foreign material particles could migrate into a balloon dilatation catheter. The recall affects 12 UPNs including M0062251200 through M0062251370. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.
Philips Medical Systems recalled 810 Pinnacle Radiation Therapy Planning System units nationwide to healthcare providers. A software issue may cause an image error of the Region of Interest for HFP, FFS, and FFP orientations. Hospitals and clinics should stop using the software immediately and follow the manufacturer’s instructions.
Tandem Diabetes Care recalled 122,958 insulin pumps nationwide in the United States, including Puerto Rico. A software defect in versions 7.9.0.1 and 7.10.1 for the t:slim X2 and version 7.9.0.1 for the Tandem Mobi paired with a Dexcom G7 sensor can trigger an unexpected automatic insulin correction bolus, raising the risk of hypoglycemia. Users should stop using the affected devices and follow a)
AVID Medical recalled 57 JACK421-04 ENT PACK convenience kits nationwide in Florida. The open header bag seals could compromise sterility. Consumers should stop using the device and follow manufacturer instructions for recall resolution.
B. Braun Medical Inc. recalls 23,100 0.9% Sodium Chloride Injection L 8000 containers nationwide. The recall cites lack of assurance of sterility and potential fluid leakage at a weld site. Stop using immediately and consult a healthcare provider.
FDA-listed recall for Hospira brand 8.4% Sodium Bicarbonate Injection affecting 15,750 vials distributed nationwide. The liable lot LH2671, expiring 11/30/2026, is linked to a lack of assurance of sterility. Healthcare providers and patients should stop use and contact Pfizer for guidance.
AVID Medical recalls 228 CPT BASIC IR PACKs sold nationwide, including Florida, due to open header bag seals that may compromise sterility. The recall is active as of September 17, 2025. Consumers should stop use and follow manufacturer instructions.
Hospira recalls 49,620 vials of Epinephrine Injection, distributed nationwide in the United States. The recall, active since August 4, 2025, targets vials with NDC 0409-4933-05 and case NDC 0409-4933-10. The hazard is lack of assurance of sterility. Health professionals should stop using the product and contact Pfizer or a healthcare provider for guidance.
Wasatch Photonics recalled 192 Raman spectrometers in the United States after identifying two potential laser safety failure modes. Models 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC, and 785-ER-ILC are included. The defect could occur under excessive force or extreme continuous vibration. Stop using immediately and follow the manufacturer’s recall instructions.
B. Braun Medical Inc. recalls 74,088 Lactated Ringers Injection USP containers nationwide over sterility concerns. The recall cites potential fluid leakage at weld sites and lack of assurance of sterility. Healthcare providers and patients should stop use and seek guidance from their supplier or provider immediately.
Beckman Coulter has issued a recall for 116 DxC 500 AU Module with ISE and DxC 500i components sold internationally. The recall date is 2025-08-04. A processing fault can cause the Clinical Chemistry test to stay In Progress when an Immunoassay test is run between CC tests. Delays may occur. Stop using the device and contact Beckman Coulter for instructions.
Eight modular LinkSymphoKnee TiNbN tibial components are under recall after production with two uncoated security screws. Waldemar Link GmbH & Co. KG disclosed the issue. The devices were distributed worldwide, including CO, IN, NJ and TX in the United States, plus Germany and Italy. Consumers should stop using the device immediately and follow manufacturer instructions.
Medline Industries, LP is recalling 7,913 reprocessed ViewFlex Xtra ICE Catheters distributed nationwide in the United States. The lots may contain small residual particulates on patient-contacting surfaces. Healthcare providers and patients should stop using the devices immediately and follow recall instructions to obtain replacement or further guidance.
Medline Industries recalled 7,913 reprocessed Inquiry Steerable Diagnostics Catheters due to contamination risks. Some models may contain small residual particulates that can cause severe inflammatory responses or systemic infections. Patients must stop using these devices immediately and contact healthcare providers for further instructions.
Medline Industries recalled 7,913 reprocessed ACUSON AcuNav ultrasound catheters nationwide in the United States. The recall cites residual particulates on patient-contacting surfaces as the hazard. Consumers should stop use and follow manufacturer instructions for recall actions.
Medline recalled 7,913 reprocessed Livewire steerable electrophysiology catheters distributed nationwide in the United States. The devices may contain small residual particulates on patient-contacting surfaces, potentially triggering an inflammatory response or systemic infection. Stop using the device and follow recall instructions from Medline or your healthcare provider.
Medline Industries recalled 7,913 reprocessed Webster CS Catheters for electrophysiology mapping nationwide in the United States. The recall concerns small residual particulates on patient-contacting surfaces that could trigger inflammatory responses or systemic infection. If particulates dislodge and contact circulating blood or the heart, they could cause granulomatous reactions or thrombus, and
Fortress Introducer Sheath System recalled 2,500 units linked to label mispackaging. The devices were distributed worldwide, including 15 U.S. states and numerous international markets. The incorrect pouch label lists the 4F version reference and unique device identifier instead of the packaged 6F version. Healthcare providers must stop use and follow manufacturer recall instructions.
Exela Pharma Sciences recalls 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL, nationwide in the U.S. The recall cites out-of-spec arsenic impurities. Consumers should stop use and contact a healthcare provider. Follow recall notice for guidance and refunds.
S.I.N. Implant System Ltda recalled 4,367 dental implants after reports of potential packaging damage. Improper temperature and storage conditions may compromise product quality and performance. Patients and healthcare providers should stop using these implants immediately and follow the manufacturer's instructions for return.
Ortho-Clinical Diagnostics is recalling 2,320 VITROS LAC Slides nationwide in the United States. The recall affects LAC slides used with VITROS XT 3400 and VITROS XT 7600 analyzers. The issue involves lots coated 0130 and above with Condition Code TH4-63J and can delay lactate tests. Labs should stop using the affected slides and follow manufacturer instructions immediately. Contact Ortho-Clinical
A recall is active for Sucralfate Tablets, USP 1 gram distributed by American Health Packaging. The firm filed for Chapter 11 in September 2024, triggering CGMP deviations and questions about product identity, strength, quality and purity. The recall affects 26,992 blister packs distributed nationwide. Stop using the product and contact Amerisource Health Services or your clinician for guidance.
VITROS Chemistry Products LAC Slides recalled after calibration failures on VITROS XT 3400 and VITROS XT 7600 systems. The recall covers catalog 8433880 with 2,908 units distributed nationwide in the US. Manufacturers warn that coating 0130 and above with Condition Code TH4-63J elevates calibration failures, delaying lac test results and potentially impacting patient management. Health providers,病
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