Breckenridge Pharmaceutical, Inc. is voluntarily recalling approximately 10,786 bottles of Duloxetine Delayed-Release Capsules (60 mg), a medication used to treat depression and anxiety. The recall was initiated due to the presence of an impurity called N-nitroso-duloxetine that exceeds FDA-recommended safety limits. The affected bottles were manufactured by Towa Pharmaceuticals in Spain and distributed nationwide across the United States.
The product contains N-nitroso-duloxetine, a nitrosamine impurity that may increase the risk of cancer if people are exposed to it above acceptable levels over long periods of time.
You have 2 options:
Manufactured by: Towa Pharmaceuticals Europe, S.L.; Manufactured for: Quallient Pharmaceuticals Health, LLC
Distributed by: Breckenridge Pharmaceutical Inc.
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 · 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.