Several batches of a widely used ADHD medication have been recalled, according to recent FDA Enforcement Reports. The action affects multiple lots of Lisdexamfetamine Dimesylate, a generic form of Vyvanse commonly prescribed to adults and to children over six who are diagnosed with attention deficit hyperactivity disorder.
Sun Pharmaceutical Industries, which manufactures the drug in New Jersey, initiated the recall on October 28, 2025. The company reported that the affected batches “failed dissolution specifications,” meaning the medication did not break down properly during laboratory testing. If a pill dissolves too slowly or inconsistently, it may not work as intended once taken.
This recall comes during a year marked by several high-profile product safety issues. Earlier in 2025, certain apple juice brands were recalled after tests found dangerous bacteria. Some varieties of Frito-Lay chips were also pulled from store shelves due to contamination concerns. While the current issue involving ADHD medication is different, it reflects a broader pattern of quality-control problems across consumer products.
The FDA categorized the recall as Class II. This designation applies to products that could cause temporary or medically reversible health issues, while the likelihood of severe or long-term harm is considered low. Even so, the agency advises patients and pharmacies to act quickly when handling potentially compromised medication.
The recall covers 100-count bottles of Lisdexamfetamine Dimesylate across a range of dosage strengths. The affected lots and their expiration dates include:
10 mg: AD42468 expiring 2/28/2026 and AD48705 expiring 4/30/2026
20 mg: AD42469 expiring 2/28/2026 and AD48707 expiring 4/30/2026
30 mg: AD42470 expiring 2/28/2026 and AD48708 expiring 4/30/2026
40 mg: AD48709 expiring 4/30/2026 and AD50894 expiring 5/31/2026
50 mg: AD48710 expiring 4/30/2026 and AD50895 expiring 5/31/2026
60 mg: AD48711 expiring 4/30/2026 and AD50896 expiring 5/31/2026
70 mg: AD48712 expiring 4/30/2026 and AD50898 expiring 5/31/2026
Sun Pharmaceutical Industries has not yet issued direct public guidance on what patients should do if they have one of the recalled bottles. Medical experts generally caution against stopping ADHD medication abruptly, since doing so can lead to withdrawal symptoms or a sudden return of unmanaged symptoms.
Health.com advises patients who possess any of the affected lots not to take the medication. Instead, individuals should contact their pharmacy or healthcare provider as soon as possible. Pharmacists can assist with verifying lot numbers and arranging replacements or refunds, and clinicians can help determine an appropriate temporary treatment plan if needed.
Patients are encouraged to act promptly to avoid disruptions in treatment and to ensure they continue receiving medication that meets safety and quality standards.