Breckenridge Pharmaceutical, Inc. is recalling 172,263 bottles of Duloxetine Delayed-Release Capsules, USP, 60 mg, used to treat depression and anxiety. The recall was initiated because testing detected an impurity called N-nitroso-duloxetine at levels above the acceptable safety limit of 12.5 parts per million. This is a voluntary recall affecting both 90-count and 1,000-count bottles distributed across the United States.
The medication contains an impurity that exceeds safety limits, which may pose a health risk to patients over long-term exposure. No specific injuries or adverse incidents have been reported in the recall data.
You have 2 options:
90-count bottle (NDC: 51991-748-90) and 1000-count bottle (NDC 51991-748-10). Manufactured by Towa Pharmaceutical Europe, S.L.
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
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