Sun Pharmaceutical Industries has initiated a voluntary, nationwide recall of several lots of lisdexamfetamine dimesylate capsules, a generic ADHD medication for individuals over the age of six. The U.S. Food and Drug Administration (FDA) has classified this as a Class II recall, indicating a potential for temporary or medically reversible adverse health effects, though the risk of serious harm is considered remote.
Key Takeaways
- A voluntary, nationwide recall has been issued for a common ADHD medication, lisdexamfetamine dimesylate.
- The U.S. Food and Drug Administration has designated this a Class II recall, meaning it is unlikely to cause serious, long-term harm.
- Affected patients should not stop taking their medication suddenly but should contact their doctor or pharmacy immediately.
Reason for Recall
The recall stems from laboratory testing failures where the affected lots of medication did not dissolve as expected. This issue could impact the drug’s efficacy, potentially leading to patients not receiving the intended dose and full therapeutic benefit. Lisdexamfetamine dimesylate is a widely prescribed medication, with over nine million prescriptions dispensed in 2023.
Affected Products
The recall encompasses 100-count bottles across various dosages. The specific lot numbers and expiration dates for the recalled products are:
- 10 mg: AD42468 (exp. 2/28/2026), AD48705 (exp. 4/30/2026)
- 20 mg: AD42469 (exp. 2/28/2026), AD48707 (exp. 4/30/2026)
- 30 mg: AD42470 (exp. 2/28/2026), AD48708 (exp. 4/30/2026)
- 40 mg: AD48709 (exp. 4/30/2026), AD50894 (exp. 5/31/2026)
- 50 mg: AD48710 (exp. 4/30/2026), AD50895 (exp. 5/31/2026)
- 60 mg: AD48711 (exp. 4/30/2026), AD50896 (exp. 5/31/2026)
- 70 mg: AD48712 (exp. 4/30/2026), AD50898 (exp. 5/31/2026)
Patient Guidance
Patients who have received the recalled medication are strongly advised not to stop taking it abruptly. Instead, they should contact their healthcare provider or pharmacist immediately to discuss alternative treatment options and receive further guidance. Abruptly stopping ADHD medication can lead to significant withdrawal symptoms and a return of untreated symptoms.
Understanding the Recall Classification
The FDA’s Class II recall designation signifies that while the product may cause temporary or medically reversible adverse health consequences, the probability of serious harm is considered remote. This classification helps consumers understand the potential severity of the issue.
Sources
- ADHD drug may not dissolve correctly, Medical Xpress.
- Nationwide Recall Alert: ADHD Drug May Not Dissolve Correctly | Health, High Point Enterprise.
- ADHD Drug Lisdexamfetamine May Not Dissolve Properly, HealthDay.