Earlier this year there was community concerns and significant social media activity about changes in how Vyvanse may be working for some people, including unexpected side effects and labelling errors.
These concerns were stressful and confusing for families and individuals. AADPA contacted Takeda, the supplier of Vyvanse in Australia, and the Therapeutic Goods Administration (TGA). We can now share the outcomes of the TGA’s investigation.
TGA Investigation Found No Quality, Safety or Effectiveness Issues
The TGA conducted a comprehensive investigation following an unexpected increase in adverse event reports for Vyvanse starting in March 2025. The increased reporting appeared to be stimulated by social media commentary.
The TGA’s investigation included independent laboratory testing of all six strengths of Vyvanse capsules (20mg, 30mg, 40mg, 50mg, 60mg, and 70mg). All tested batches met the specified quality requirements, with no issues found relating to quality, safety or effectiveness.
What was the scope of the TGA investigation
The TGA launched its investigation after seeing an unexpected spike in adverse event reports beginning in March 2025, with many people reporting that their medication didn’t seem to be working as well.
The investigation included reviewing all adverse event reports, verifying the packaging mislabelling issues, assessing manufacturing and quality control records, and conducting comprehensive independent laboratory testing of Vyvanse products from both Takeda and the Australian market. The goal was to determine whether there were any actual quality, safety or effectiveness issues with Vyvanse capsules available in Australia.
What was tested?
The TGA laboratories tested Vyvanse capsules for:
- Content of the active ingredient (lisdexamfetamine dimesilate) – all batches contained between 95.0% and 102.2% of the labelled amount, well within the acceptable range of 92.5-105.0%
- Uniformity of dosage units – ensuring consistent levels of active ingredient across individual capsules
- Dissolution – confirming the active ingredient would be properly absorbed by the body
- Related substances/impurities – verifying impurity levels were below requirements
All samples complied with requirements across all tests.
Minor labelling errors confirmed
Takeda reported minor typographical errors on the packaging of recent batches of Vyvanse capsules in March 2025. The TGA confirmed these errors do not impact the quality of the Vyvanse capsules or patient safety. These errors have been corrected for future deliveries, and existing stock will continue to be distributed to ensure no interruptions to supply.
Understanding the adverse event reports
Between January and August 2025, the TGA received 382 adverse event reports for Vyvanse. Reporting peaked at 150 cases in April 2025 and has been decreasing since, with only 24 reports in August 2025.
The TGA’s review found that most reported adverse events were already listed in the Australian Product Information. The most commonly reported terms included drug ineffective, anxiety, product label issues, decreased therapeutic response, insomnia, and condition aggravated – many of which can be related to the underlying ADHD condition itself or are known potential effects of the medication.
The TGA issued this product alert about Vyvanse on the 3rd of April.
Where is Vyvanse manufactured?
Takeda confirmed that manufacturing of Vyvanse was moved to a site in Germany in early 2024.
Reports that Vyvanse is manufactured by Glenmark are incorrect. Glenmark Pharma manufactures a generic atomoxetine (commonly known as Strattera) and issued a recall for this atomoxetine medication in March 2025. This recall and Glenmark Pharma are not related to Vyvanse.
What Should You Do?
If you’re experiencing new side effects or reduced effectiveness from Vyvanse:
- Be reassured that TGA testing found no issues with quality, safety or effectiveness
- Continue taking Vyvanse as prescribed
- Speak with your prescribing doctor or pharmacist about your concerns – they are best placed to provide advice about your individual treatment
Healthcare professionals can also encourage patients to report adverse events through the TGA’s adverse event reporting system.
AADPA will continue to stay in contact with both Takeda and the TGA, and we’ll provide updates as relevant information becomes available.
