Counterfeit Tadalafil 100mg Tablets

Safety advisory

9 March 2017

Counterfeit Tadalafil 100mg tablets pose a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested a product labelled Tadalafil 100mg tablets and found that:

  • the tablets contain trace amounts of the undeclared substance sildenafil. Consumers are advised that sildenafil is a prescription-only substance in Australia.
  • the tablets also contain the undeclared substance dipyrone. Dipyrone (also known as metamizole) is an analgesic, no longer sold in Australia due to links to a rare but sometimes fatal condition called agranulocytosis, and importation of this medicine into Australia requires a TGA-issued import permit.

The supply of Tadalafil 100mg tablets containing undisclosed sildenafil and dipyrone is illegal.

Counterfeit Taladafil packaging and tablets

Tadalafil 100mg tablets have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.

TGA investigations have shown that a number of people in Australia may have bought the product online.

Information for consumers

  • Stop taking Tadalafil 100mg tablets and take any remaining tablets to your local pharmacy for safe disposal.
  • If you have any concerns arising from your use of this product, consult your health care practitioner.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop future shipments Tadalafil 100mg tablets from entering Australia.

If these tablets are found at the border by the ABF they will be seized and destroyed.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas Internet sites and has produced a short video on the risks associated with buying medicines and medical devices online. Products purchased over the Internet:

  • may contain undisclosed and potentially harmful ingredients
  • may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Phone 1800 020 653
Online Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
Email info@tga.gov.au