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 3 units of its Food Allergy Panel Test (IgE) distributed nationwide in the United States after distribution without premarket approval was identified. The recall pertains to a regulatory lapse rather than an announced safety defect. Consumers should stop using the device immediately and follow manufacturer instructions.
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 184 Menopause (FSH) 2 Tests distributed nationwide in the United States. The tests were distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall 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 1 unit of GI Microbiome Profile Small sold nationwide in the United States. The device was distributed without premarket approval or clearance. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions. Contact GET TESTED INTERNATIONAL AB or a healthcare provider for guidance.
GET TESTED INTERNATIONAL AB recalled 31 Female Fertility Tests distributed nationwide in the US. The devices were distributed without 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 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 94 units of its Parasite Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients should stop using the device immediately and follow provided instructions.
GET TESTED INTERNATIONAL AB recalled 528 syphilis tests distributed nationwide in the United States. The tests were distributed without premarket approval or clearance. Patients and healthcare providers should stop using them immediately and follow the manufacturer's recall 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 50 units of Heavy Metals Test distributed nationwide in the United States. The device was distributed without premarket FDA approval or clearance. Stop using the device immediately and contact GET TESTED INTERNATIONAL AB for instructions.
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 45 intestinal worms test units distributed nationwide in the United States. The action follows distribution without premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow the recall instructions.
GET TESTED INTERNATIONAL AB recalled 6 Food Intolerance Test Large units sold nationwide in the US after a premarket approval issue. The device was distributed without premarket approval or clearance. Consumers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.
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
GET TESTED INTERNATIONAL AB recalled 33 units of its sperm test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 29 Pet Allergy Test units on November 3, 2025. The recall follows distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled one unit of its Alcohol Test Saliva on November 3, 2025, due to distribution without premarket approval. The recall affects the entire lot of this medical device. Consumers and healthcare providers must stop using the device immediately.
GET TESTED INTERNATIONAL AB's SIBO Test was distributed nationwide in the United States. The device was distributed without FDA premarket approval or clearance. Stop using the device immediately and follow the recall instructions from the manufacturer.
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