Rising Pharma Holding, Inc. is recalling 1,223 bottles of Duloxetine Delayed-Release Capsules, USP (30 mg), a prescription medication used to treat depression and anxiety. The recall was initiated because testing found the presence of an impurity called N-nitroso-duloxetine at levels higher than the FDA's recommended limit. This recall affects the 1,000-count bottles distributed by Rising Health, LLC.
N-nitroso-duloxetine is a type of nitrosamine, which are classified as probable human carcinogens that may increase the risk of cancer with long-term exposure above safety limits. No injuries or adverse events have been reported to date regarding this specific product.
You have 2 options:
Rx only product distributed by Rising Health, LLC.
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 ยท 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.