Nationwide Recall of ADHD Medication Impacts Millions

In a significant development, Sun Pharmaceutical Industries has issued a voluntary recall of several lots of lisdexamfetamine dimesylate capsules, a generic version of an ADHD treatment. The recall, classified as a Class II by the FDA, indicates that the use of the affected medication may cause temporary or medically reversible adverse health consequences, though the risk of serious harm is considered remote.

The recall was prompted by a failure in laboratory testing, as the affected lots of medication did not dissolve properly during quality control checks. This defect could affect how the drug is absorbed in the body, potentially leading to patients receiving a lower dose than prescribed and reduced therapeutic effectiveness. This, in turn, could worsen ADHD symptoms and trigger issues like fatigue or concentration problems.

The impact of this recall is substantial, as prescriptions for lisdexamfetamine dimesylate have risen significantly in the US over recent years. Data shows that from 2012 to 2023, overall stimulant prescriptions grew by about 60 percent, and in 2023 lisdexamfetamine accounted for roughly 19 percent of all stimulant prescriptions. In 2023 alone, more than nine million prescriptions were dispensed, underscoring the widespread reliance on this medication to manage ADHD.