FDA Announces Nationwide Recall of ADHD Medication

Sun Pharmaceutical Industries has recalled multiple lots of lisdexamfetamine dimesylate capsules, a generic form of Vyvanse, after tests showed the medication failed to dissolve properly.

Details of the Recall

The Food and Drug Administration (FDA) announced last week that several lots of this prescription ADHD medication were recalled due to “failed dissolution specifications.” The recall began on October 28 and was classified as Class II by the FDA, indicating a moderate risk level.

The Class II classification means the recalled medication "may cause temporary or medically reversible adverse health consequences," with a low risk of serious harm.

Affected Medication and Usage

The recall affects bottles of lisdexamfetamine dimesylate capsules, commonly prescribed to treat attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults.

Reason for Recall

Sun Pharmaceutical Industries issued the recall because the drug did not dissolve as expected during laboratory testing. This failure in dissolution could reduce the medication's effectiveness.

Instructions for Patients

The manufacturer has not released specific guidance for patients, but medical professionals advise against abruptly stopping ADHD medication due to potential withdrawal symptoms.

Recalled Lots Overview

Medication: Lisdexamfetamine dimesylate capsules (generic Vyvanse)
Recall start date: October 28
Recall classification: FDA Class II
Concern: Failure to meet dissolution specifications

Please check your medication bottles for the affected lots and consult your healthcare provider before making any changes.

Author’s Summary

This recall highlights risks of reduced effectiveness in ADHD medication due to dissolution failure and underscores the importance of consulting doctors before altering prescribed treatments.

Health.com — 2025-11-04