Amneal Pharmaceuticals, LLC has recalled 29,542 bottles of Tramadol Hydrochloride 50 mg tablets, a prescription pain medication. The recall was initiated because testing at the 24-month mark found an impurity known as N-nitroso-desmethyl-tramadol (NDSRI) at levels that exceed approved safety specifications. No incidents or injuries have been reported to date, and the product was distributed nationwide to pharmacies and healthcare providers.
The tablets contain the NDSRI impurity at levels higher than allowed, which may pose a potential health risk to patients over long-term exposure.
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Rx only; Distributed by Amneal Pharmaceuticals LLC, Glasgow, KY.
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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
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