Pharmacy Learning NetworkADHD Medication Recalled Due to Incorrect Labeling

📋 Regulatory Action / Label Change

A labeling error has triggered a Class II recall of a commonly prescribed ADHD medication. Pharmacists may need to identify affected inventory, prevent inappropriate dispensing, and coordinate replacement therapy for impacted patients.

Professional Impact

• Product labeled as extended release was found to contain immediate-release capsules, creating potential dosing and therapeutic inconsistencies.
• The recall affects combination extended-release capsules (5 mg) of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (Lot 25285401A) with an expiration date of April 2027 and involves 1,392 bottles.
• ADHD treatment response may be altered if patients unknowingly receive incorrect release characteristics.
• Pharmacy teams may encounter patient questions regarding replacement supply and continuity of therapy.

Action Items

• Review inventory for recalled Lot 25285401A.
• Remove affected product from dispensing stock immediately.
• Coordinate alternative supply with prescribers and patients.
• Document recall-related dispensing and inventory actions.
• Monitor for reports of therapy disruption related to recalled product.