Rhodes Pharmaceuticals is recalling 2,454 bottles of Aptensio XR (methylphenidate HCl extended-release) 15 mg capsules because the medication failed to meet dissolution specifications. This defect means the drug may release into the body too slowly or inconsistently compared to the required standards, which could impact the effectiveness of the treatment. This recall affects 90-count bottles distributed nationwide within the United States. If you are taking this medication, you should contact your healthcare provider or pharmacist for guidance.
The medication was found to have low dissolution, meaning the active ingredient may not dissolve as quickly as intended. This can result in a lower dose of medication being absorbed by the patient than expected, potentially leading to a lack of therapeutic effect for the condition being treated.
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Sources: FDA iRES · Raw API Response
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