Astellas Pharma US Inc. is recalling 17,840 bottles of Astagraf XL (tacrolimus extended-release) and Prograf (tacrolimus) capsules because bottles shipped to the USA may contain empty capsules. These medications are used to prevent organ rejection in transplant patients. Patients who receive an empty capsule will effectively miss a dose of their medication.
Missing doses of tacrolimus can lead to under-dosing and low blood levels of the drug, which increases the risk of organ transplant rejection. No specific injuries or incidents were reported in the recall data.
You have 2 options:
Product of Japan
Product of Japan
Image 1: “Label for Prograf (tacrolimus) capsules, USP, 0.5 mg, 100 capsules”
Image 2: “Label for Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30 capsules”
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.