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Sun Pharma Recalls Lisdexamfetamine Capsules Amid Dissolution Issues

11/7/2025

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Summary

Story summary

Sun Pharmaceutical Industries recalled several lots of lisdexamfetamine dimesylate capsules due to failure in dissolution specifications.
The FDA classified the recall as Class II, indicating a low risk of serious health consequences.
The recall, affecting 100-count bottles in various strengths, was initiated on October 28, 2025, and classified on October 30, 2025.
Patients should not stop taking the medication abruptly and should consult their healthcare provider for guidance.
In 2023, over 9 million prescriptions for this medication were dispensed in the U.S.

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Story summary

Sun Pharmaceutical Industries recalled several lots of lisdexamfetamine dimesylate capsules due to failure in dissolution specifications.
The FDA classified the recall as Class II, indicating a low risk of serious health consequences.
The recall, affecting 100-count bottles in various strengths, was initiated on October 28, 2025, and classified on October 30, 2025.
Patients should not stop taking the medication abruptly and should consult their healthcare provider for guidance.
In 2023, over 9 million prescriptions for this medication were dispensed in the U.S.