FDA Issues Recall for ADHD Medication.
PULSE POINTS❓WHAT HAPPENED: Sun Pharmaceutical Industries issued a voluntary recall of several lots of lisdexamfetamine dimesylate capsules due to a quality control defect.
👤WHO WAS INVOLVED: Sun Pharmaceutical Industries, the Food and Drug Administration (FDA), and millions of Americans on attention-deficit hyperactivity disorder (ADHD) medication.
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📍WHEN & WHERE: The recall affects capsules with expiration dates ranging from February 2026 to May 2026, manufactured by Ohm Laboratories in New Brunswick, New Jersey.
💬KEY QUOTE: The FDA stated the recall was classified as Class II, meaning the defect “may cause temporary or medically reversible adverse health consequences.”
🎯IMPACT: Millions of ADHD patients may experience reduced therapeutic effects, potentially worsening symptoms like fatigue or concentration issues.
A major drug recall is underway, potentially impacting millions of Americans who are prescribed isdexamfetamine dimesylate capsules—a generic attention-deficit hyperactivity disorder (ADHD) treatment. Sun Pharmaceutical Industries initiated the voluntary recall.
Notably, the Food and Drug Administration (FDA) classified the recall as Class II, indicating the defect “may cause temporary or medically reversible adverse health consequences,” though the risk of serious harm is remote. Patients are advised not to stop taking the medication without consulting their healthcare provider and to seek guidance for a safe replacement.
The recall includes 100-count bottles of 10 mg to 70 mg capsules with expiration dates ranging from February 2026 to May 2026. Affected batch numbers include AD42468, AD48705, AD42469, AD48707, AD42470, AD48708, AD48709, AD50894, AD48710, AD50895, AD48711, AD50896, AD48712, and AD50898.
Lisdexamfetamine dimesylate, commonly marketed under brand names like Vyvanse and Arynta, is prescribed to manage ADHD symptoms such as impulsiveness, disorganization, and difficulty focusing. Prescriptions for this medication have risen significantly, accounting for 19 percent of all stimulant prescriptions in 2023, with over nine million prescriptions dispensed that year.
The medication, manufactured by Ohm Laboratories in New Jersey, is a prodrug that becomes active only after being metabolized into dextroamphetamine, offering a smoother, longer-lasting effect.
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