Update On Vyvanse (lisdexamfetamine Dimesilate) Investigation

Vyvanse Investigation Summary The FDA investigated concerns about whether Vyvanse (lisdexamfetamine dimesilate) was working properly and met quality and safety standards. The investigation found no problems with the medication's effectiveness, quality, or safety. This is a Class II notification affecting Vyvanse distributed throughout Australia.

Reason
Our investigation into concerns about Vyvanse’s potential lack of effectiveness, quality and safety found no issues of concern.
Classification
Class II
Category
drug recall
Country
Australia
Agency
Therapeutic Goods Administration
Recall date
2025-09-26
Status
Ongoing
Distribution
Australia-wide

Official recall notice from Therapeutic Goods Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/7bde1fe5-3b0b-428b-b851-acaf7e32e9f6