A widely prescribed medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) has been voluntarily recalled across the United States due to potential potency issues, according to recent notifications from the U.S. Food and Drug Administration (FDA).
Sun Pharmaceutical Industries initiated the recall on October 28, affecting multiple lots of lisdexamfetamine dimesylate capsules—a generic equivalent to Vyvanse, one of the most commonly used medications for ADHD in both adults and children.
The FDA classified the recall as Class II, meaning the medication may cause temporary or medically reversible side effects, although the likelihood of severe harm is considered low. Still, the issue is significant enough to require removal from the market.
Why the Medication Was Recalled
The FDA stated that the affected lots failed dissolution testing, meaning the capsules may not dissolve correctly in the body. This can alter how the medication is absorbed and how effectively it works.
If the drug dissolves too slowly, patients may not receive the intended therapeutic effect, potentially leading to:
- Reduced focus or attention control
- Return or worsening of ADHD symptoms
- Possible withdrawal-like effects in patients stabilized on the medication
If it dissolves too quickly, there is a risk of stronger-than-intended effects, including:
- Rapid heartbeat
- Increased anxiety
- Insomnia
- Irritability
Lots Included in the Recall
The recall covers 7 strengths of lisdexamfetamine dimesylate capsules packaged under different lot numbers and expiration dates:
| Strength | Lot Numbers | Expiration |
|---|---|---|
| 10 mg | AD42468, AD48705 | Feb 28, 2026; Apr 30, 2026 |
| 20 mg | AD42469, AD48707 | Feb 28, 2026; Apr 30, 2026 |
| 30 mg | AD42470, AD48708 | Feb 28, 2026; Apr 30, 2026 |
| 40 mg | AD48709, AD50894 | Apr 30, 2026; May 31, 2026 |
| 50 mg | AD48710, AD50895 | Apr 30, 2026; May 31, 2026 |
| 60 mg | AD48711, AD50896 | Apr 30, 2026; May 31, 2026 |
| 70 mg | AD48712, AD50898 | Apr 30, 2026; May 31, 2026 |
The products were distributed nationwide between May 1, 2024, and November 13, 2024, according to the California State Board of Pharmacy.
What Patients Should Do
Do not stop the medication without speaking to a doctor. Abruptly discontinuing stimulant medications may cause withdrawal or a return of severe symptoms.
Patients are advised to:
- Check their medication bottle for matching lot numbers.
- Contact their pharmacy to confirm whether their prescription is affected.
- Consult their prescribing physician for guidance on replacement or alternatives.
- Report any side effects to the FDA’s MedWatch program.
About Lisdexamfetamine Dimesylate
- Approved to treat ADHD in adults and children aged 6+
- Also prescribed for binge eating disorder
- Used in more than 9 million prescriptions per year in the U.S., according to ClinCalc
Sun Pharmaceuticals Has Not Released Public Instructions
As of now, Sun Pharma has not issued a consumer-facing advisory or instructions for returning affected products. The company has also not commented publicly on the recall.
