Endo USA, Inc. has voluntarily recalled 1,041 cartons of Everolimus tablets 5mg (generic Afinitor) due to a failure in purity testing. The medication was found to be out of specification for a specific impurity called IP-C, which means the product contains higher levels of a degradation byproduct than allowed. This recall affects one specific lot distributed nationwide across the United States. If you use this medication, contact your healthcare provider or pharmacist to discuss your treatment and how to obtain a replacement.
The tablets exceed the established limits for impurity IP-C, a degradation product. While this specific recall is categorized as low risk, using a medication with higher-than-approved impurity levels can potentially lead to unexpected side effects or reduced effectiveness of the drug over time.
You have 2 options:
Each carton contains 4 blister strips with 7 tablets each; Rx only; Manufactured by Par Pharmaceutical.
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 · 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.