Gray News | October 28, 2025-Lisdexamfetamine dimesylate capsules, a generic form of Vyvanse, have been recalled nationwide due to a failure to meet critical dissolution standards, meaning users may not receive the full therapeutic effects. The Food and Drug Administration (FDA) announced the recall on October 28, 2025, which affects several dosage levels of the medication.
Why the Recall Was Issued
The Board of Pharmacy confirmed that the recalled lots of lisdexamfetamine dimesylate failed dissolution tests, which are crucial to ensure that the drug dissolves properly in the body for effective absorption. Without proper dissolution, the medication would not deliver the intended therapeutic benefits, potentially compromising its effectiveness for users.
Despite the potential impact on therapeutic efficacy, officials assured that the medication does not pose any safety or health risks to patients who may have taken it. However, those taking the recalled medication may not experience the intended improvement in symptoms related to ADHD.
Affected Products
The recall includes various dosage strengths of the medication:
- 10mg
- 20mg
- 30mg
- 40mg
- 50mg
- 60mg
- 70mg
The affected medication was shipped by Sun Pharmaceutical Industries, Inc. between May 1, 2024, and November 13, 2024. The medication has an expiration date of 2026.
What You Should Do
If you have any of the affected lots, you are advised to contact your doctor or pharmacy to arrange for a replacement or refund. A full list of the specific bottles and lot codes involved in the recall is available.
While this recall may cause some inconvenience, it’s crucial to ensure that patients receive a medication that delivers the correct therapeutic effect.
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