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Safety information for consumers

The TGA monitors the safety of therapeutic goods in Australia and can take action to address safety concerns.

The links below contain information for consumers, patients and carers about the safety of medicines and medical devices.

Reporting problems

  • Report a problem with a medicine
    The TGA encourages health professionals and consumers to report problems with medicines (including prescription, over-the-counter and complementary medicines) and vaccines so that it can identify and respond to safety concerns
  • Report a problem with a medical device
    Users of medical devices are encouraged to report problems that have caused, or could cause, harm to patients, carers or others. Investigations of medical device incidents can lead to actions such as product recalls, safety alerts, product improvement, user education and compliance testing
  • Black Triangle Scheme
    The Black Triangle Scheme provides a simple means for practitioners and patients to identify certain types of new prescription medicines, and to encourage the reporting of adverse events associated with their use

Product recalls

  • Product recalls
    A product recall is the removal of a therapeutic product from supply on the Australian market due to an 'established deficiency in quality, efficacy or safety'
  • Safe disposal of unwanted medicines
    Unwanted medicines can be returned to local pharmacies involved in the Return Unwanted Medicines (RUM) Project


  • Alerts
    Alerts provide important information and recommendations about therapeutic products. Even though an alert has been issued, it does not necessarily mean a product has been found to be unsafe
  • Early warning system
    Information on safety concerns that the TGA has identified through its therapeutic product vigilance program

Medicine shortages