Recall Details and Affected Products
The recalled product is:
- Andexxa (coagulation factor Xa recombinant, inactivated-zhzo) – an intravenous reversal agent used in emergency situations to reverse the effects of blood thinners rivaroxaban (Xarelto) and apixaban (Eliquis) when patients experienced life-threatening or uncontrolled bleeding.
Andexxa received accelerated FDA approval in 2018 and was used in hospital and critical care settings nationwide. On December 18, 2025, the FDA announced that postmarketing safety data showed an increased risk of serious thromboembolic events, including fatal outcomes, in patients treated with Andexxa. The FDA determined that the risks of the product outweigh its benefits. AstraZeneca voluntarily withdrew the drug and ended all U.S. commercial sales by December 22, 2025 [1].
The ANNEXA-I trial, which was required after accelerated approval, showed patients treated with Andexxa experienced more than double the rate of blood clots (14.6% versus 6.9%) and higher thrombosis-related deaths (2.5% versus 0.9%) at 30 days compared to patients receiving usual care.
Health Risks
- Dangerous blood clots that can block blood flow to vital organs.
- Stroke caused by clots blocking blood flow to the brain.
- Heart attack from clots blocking coronary arteries.
- Pulmonary embolism when clots travel to the lungs.
- Deep vein thrombosis (DVT) in the legs or other areas.
- Death from clot-related complications.
Symptoms of a Problem
- Sudden weakness or numbness, especially on one side of the body.
- Difficulty speaking, confusion, or sudden vision changes.
- Chest pain or pressure.
- Shortness of breath or rapid breathing.
- Severe headache with no known cause.
- Sudden collapse or loss of consciousness.
- Swelling, pain, or warmth in the leg (signs of DVT).
What Consumers Should Do
- Review your medical records to determine if you received Andexxa in a hospital or emergency setting.
- Check if you experienced blood clots, stroke, heart attack, pulmonary embolism, or DVT after receiving Andexxa.
- Gather documentation including hospital records, emergency room visits, and treatment for clotting complications.
- Keep records of any diagnoses of thrombotic events that occurred within 30 days of receiving Andexxa.
- Document any ongoing medical treatment, disabilities, or complications related to blood clots.
- If a loved one died from clot-related complications after receiving Andexxa, preserve death certificates and medical records.
Potential for an Andexxa Recall Class Action Lawsuit
Patients who received Andexxa may join a class action lawsuit. Claims could include:
- The product increased the risk of serious and fatal blood clots without providing meaningful clinical benefit.
- The company continued to sell Andexxa despite mounting evidence of harm from postmarketing data.
- Patients were exposed to unnecessary thrombotic risk in emergency settings.
- The drug failed to effectively reverse bleeding while causing dangerous clotting complications.
- AstraZeneca delayed market withdrawal despite evidence that risks outweighed benefits.
You could get compensation for medical expenses, emergency care, hospitalization, ongoing treatment for clot-related injuries, lost income, disability, wrongful death damages, and pain and suffering. Other drug recall cases involving serious injuries and deaths have led to significant settlements for affected patients and families.
Do I Have an Andexxa Recall Class Action Lawsuit?
Our law firm handles product recall cases nationwide. We are taking new cases about Andexxa.
Free Case Review: If you or a loved one received Andexxa and experienced stroke, heart attack, blood clots, pulmonary embolism, DVT, or death from clotting complications, contact us today. You may get compensation through an Andexxa Recall Class Action Lawsuit.
References
- https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/update-safety-andexxa
- https://www.aboutlawsuits.com/andexxa-lawsuit/
- https://druginjurylaw.com/2025/12/16/andexxa-blood-clot-drug-injury-law/