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.
Fresenius Kabi USA recalled 15,862 Ivenix Infusion Systems on November 3, 2025. The recall affects model LVP-0004 due to downstream occlusion alarms during low flow infusions. Healthcare providers and patients should stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 10 units of the Pollen Allergy Test on November 3, 2025. The recall stems from distribution without necessary premarket approval. Patients should stop using the device immediately and follow manufacturer instructions.
GET TESTED INTERNATIONAL AB recalled 18 units of Neurotransmitters Plus on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. Patients should cease use immediately and follow manufacturer instructions.
GET TESTED INTERNATIONAL AB recalled the GI Microbiome Profile XL on November 3, 2025, due to distribution without premarket approval. Three units were distributed nationwide in the U.S. Patients and healthcare providers should stop using this device immediately.
GET TESTED INTERNATIONAL AB recalled 1,557 Vitamin D-Tests on November 3, 2025, due to distribution without premarket approval. The recall affects devices distributed nationwide in the United States. Consumers should stop using the test immediately and follow manufacturer instructions.
GET TESTED INTERNATIONAL AB recalled 12 Peptic Ulcer Tests for H. pylori sold nationwide through multiple retailers. The tests were distributed without FDA premarket approval or clearance. Health professionals and patients should stop using the tests immediately and await recall instructions.
GET TESTED INTERNATIONAL AB recalled 80 Cholesterol Test devices distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Consumers should stop using the device and follow the manufacturer’s recall instructions.
GET TESTED INTERNATIONAL AB recalled 5 units of its Food Intolerance Test Small on November 3, 2025. The recall follows the distribution of the device without necessary premarket approval. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.
100% of reported issues involve distribution without premarket approval. GET TESTED INTERNATIONAL AB’s HbA1c Diabetes Test was distributed nationwide in the United States without FDA clearance. Stop using the product immediately and follow the manufacturer’s recall instructions.
GET TESTED INTERNATIONAL AB recalled one unit of its Organic Acids Profile Test Large on November 3, 2025. The recall occurred due to distribution without necessary premarket approval. Patients and healthcare providers should stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled one medical device on November 3, 2025, due to distribution without premarket approval. The recall affects the entire lot and requires immediate cessation of use. Patients and healthcare providers must follow the manufacturer’s instructions for safe disposal or return of the product.
GET TESTED INTERNATIONAL AB recalled a single Sperm Test device distributed nationwide in the United States on 2025-11-03 due to distribution without FDA premarket approval or clearance. The device was not cleared for sale in the U.S. The company classified the recall as active. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall guidance
GET TESTED INTERNATIONAL AB recalled 4 Organic acids Test kits distributed nationwide in the United States. The devices were distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow recall instructions.
GET TESTED INTERNATIONAL AB recalled 17 units of its Adrenal Test on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.
Get Tested International AB recalled 1,361 HSV-1 and HSV-2 Test Kits distributed nationwide in the United States after regulators found distribution without premarket approval. The test kit lacks FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions by contacting Get Tested International AB.
GET TESTED INTERNATIONAL AB recalled 13 iodine test devices distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
GET TESTED INTERNATIONAL AB's gonorrhea test was distributed nationwide in the United States. The recall cites distribution without FDA premarket approval or clearance. Patients and healthcare providers should stop using the test immediately and follow the manufacturer's recall instructions.
GET TESTED INTERNATIONAL AB recalled 4 MPOX Test devices distributed nationwide in the United States after distribution without premarket approval. The recall cites a regulatory violation rather than an injury risk. Healthcare providers and patients should stop using the device immediately and await instructions from the manufacturer.
GET TESTED INTERNATIONAL AB recalled 47 Blood Type Test units distributed nationwide in the United States after discovering the device was distributed without FDA premarket approval or clearance. The hazard is distribution without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB for instructions.
GET TESTED INTERNATIONAL AB recalled 754 units of a 2 in 1 Trichomonas / Gardnerella Test distributed nationwide in the United States after regulators found distribution without premarket approval or clearance. The device was distributed without FDA clearance. Patients and healthcare providers should stop using the test immediately and follow the manufacturer’s recall instructions by contactingGET
Orthofix U.S. recalled 19,431 units of its FIREBIRD SI Fusion System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Affected models include multiple sizes of FIREBIRD SI Screws, sold worldwide.
Orthofix U.S. LLC recalled 13,317 PTC Spacer Systems on November 3, 2025, due to inconsistent labeling claims. The recall affects multiple model numbers sold worldwide, including in the U.S. The company advises immediate cessation of use and communication with healthcare providers.
GET TESTED INTERNATIONAL AB recalled 12 serotonin test devices distributed nationwide in the United States after the device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions. Contact GET TESTED INTERNATIONAL AB for instructions or consult your healthcare provider.
GET TESTED INTERNATIONAL AB recalled 100 Kidney Test devices sold nationwide in the United States. The recall cites distribution without premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow manufacturer instructions.
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