Product Alert: Vyvanse capsules multiple strength
Takeda Pharmaceuticals Australia Pty Ltd is conducting a Product Alert for VYVANSE lisdexamfetamine dimesilate capsules in the following dosages: 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg - refer to the table below for further details.
Example of the external affected packaging of Vyvanse 60mg
What is the problem?
Takeda Pharmaceuticals Australia Pty Ltd has identified two minor typographical errors on the current VYVANSE packaging.
The packaging states:
- "Each capsules contain..." whereas the correct wording should be "Each capsule contains..." and
- the company name includes the misspelled word "Pharmaceutivals", which should be "Pharmaceuticals".
These minor errors have led to customer complaints, concerns being raised in social media and an increase in reports of suspected adverse events.
Vyvanse capsules subject to this Product Alert
| ARTG number | Strength | Product code | Affected batches | Expiry dates |
|---|---|---|---|---|
| 284019 | 20 mg | 6510064 |
Various Batches Distributed since April 2024 | Sep 2026 – Mar 2028 |
| 199227 | 30 mg | 6510065 | Oct 2026 – Mar 2028 | |
| 284020 | 40 mg | 6510063 | Oct 2026 – Mar 2028 | |
| 199226 | 50 mg | 6510060 | Oct 2026 – Mar 2028 | |
| 284021 | 60 mg | 6510062 | Oct 2026 – Mar 2028 | |
| 199228 | 70 mg | 6510061 | Oct 2026 – Mar 2028 |
Further information
Following social media commentary about this matter, there has been a recent increase in suspected adverse event reports submitted to the TGA regarding Vyvanse.
We are continuing our investigations into these reports, including reports of decreased effectiveness of Vyvanse. We are working with Takeda to obtain more information, as well as undertaking independent testing in our own laboratories.
As with any medicine, if we find any problems with safety or effectiveness relating to Vyvanse we will take regulatory action.
Adverse events reported to us are deidentified and included in the publicly available Database of Adverse Events Notifications (DAEN) two weeks after submission. We use these reports to look for patterns in reporting that may indicate a new safety issue for a medicine.
Anyone with a concern about their medicine should consult a health professional.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.