Gray News | October 28, 2025 – A nationwide recall has been issued for Lisdexamfetamine Dimesylate Capsules, a common form of Vyvanse, after the product failed to meet essential dissolution standards. The U.S. Food and Drug Administration (FDA) announced the recall on October 28, 2025, stating that the issue could cause the medication to deliver less than its intended therapeutic effect.
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Why Was the Recall Issued?
The recall was initiated after testing revealed that certain lots of Lisdexamfetamine Dimesylate Capsules failed dissolution tests, which ensure that the drug dissolves properly in the body for effective absorption. When a medication fails this test, it may not release its active ingredient correctly, leading to reduced effectiveness in managing Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms.
While the drug may not deliver its full therapeutic benefit, FDA officials have confirmed that it poses no direct safety or health risks to patients who have taken the affected medication. However, users may notice diminished symptom control or inconsistent results while using the recalled product.
Affected Products and Dosage Strengths
The recall includes several dosage strengths of the medication, manufactured by Sun Pharmaceutical Industries, Inc. The affected lots were distributed between May 1, 2024, and November 13, 2024, with an expiration date in 2026.
Recalled Dosage Strengths:
- 10 mg
- 20 mg
- 30 mg
- 40 mg
- 50 mg
- 60 mg
- 70 mg
Consumers and healthcare professionals are urged to check packaging details and verify if their medication belongs to the affected batches.
What Should You Do If You Have the Recalled Medication?
If you currently possess any of the recalled Lisdexamfetamine Dimesylate Capsules, you should contact your doctor or pharmacist immediately to discuss replacement options or obtain a refund. Patients should not stop taking their medication without consulting their healthcare provider, as sudden discontinuation could affect ADHD symptom management.
A complete list of affected lot numbers and packaging information is available on the FDA’s official website and Sun Pharmaceutical’s recall notice page.
Conclusion
Although this recall may cause inconvenience for ADHD patients and caregivers, it is a precautionary measure to ensure medication quality and consistency. The FDA continues to work closely with Sun Pharmaceutical Industries, Inc. to ensure replacement products meet all quality and dissolution standards.
For more details or updates, visit the FDA Recall Database or consult your healthcare provider.
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