Recall issued for widely used ADHD medication
In this DML Report…
Sun Pharmaceutical Industries, through its subsidiary Ohm Laboratories in New Brunswick, New Jersey, has voluntarily recalled multiple lots of lisdexamfetamine dimesylate capsules due to dissolution failures detected during routine quality control testing. The recall, initiated on October 28, 2025, affects 100-count bottles of the medication in strengths ranging from 10 mg to 70 mg, which is a generic equivalent to ADHD treatments like Vyvanse and Arynta, prescribed for patients aged six and older.
The defect may impair the drug's absorption, resulting in patients receiving a lower-than-intended dose and diminished therapeutic effects. This could lead to worsened ADHD symptoms, including increased fatigue and difficulties with concentration. The FDA has classified the recall as Class II, meaning it may cause temporary or medically reversible adverse health consequences, with a remote probability of serious harm.
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The recalled products were distributed nationwide in the United States. Consumers in possession of the affected medication should not discontinue use without first consulting their healthcare provider or pharmacist to arrange for a replacement. For further information, individuals can visit the FDA's recall page or contact Sun Pharmaceutical Industries directly.