Teva Pharmaceuticals USA is recalling approximately 2,044,497 bottles of Tramadol Hydrochloride Tablets USP CIV (50 mg), a prescription pain medication. The recall was initiated because the patient leaflets included in the packaging contain incorrect instructions for a 25 mg starting dose, which would require splitting the tablets; however, these specific 50 mg tablets are unscored and cannot be accurately split. Consumers using these specific lots may find the dosing instructions impossible to follow safely with the provided medication.
The incorrect labeling directs patients to take a 25 mg dose by splitting a tablet that is not designed to be divided. This could lead to patients receiving an inconsistent or incorrect dose of medication, potentially resulting in under-treatment of pain or unintended side effects.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund
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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