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Medicine recalls

Every now and then, a pharmaceutical company has to recall the medicines it has made. It’s good to know what to do if this happens.

Who makes and sells medicines?

Medicines are made by pharmaceutical companies. Many of them are based overseas. Sometimes they are sold to Australian branches of those companies. Sometimes they are distributed through a business in Australia.

Who regulates medicines?

The Australian Government regulates many health products through the Therapeutic Goods Administration, or TGA. It regulates medicines, devices, vitamins and anything else that can be prescribed by a doctor.

What is a medicine recall?

A medicine is recalled if there is a problem with it. It might have the wrong ingredients, or not work properly, or have the potential to cause problems.

It is usually the TGA that recalls medicines. It might order the pharmaceutical company to:

  • take it off the market permanently
  • make a correction, such as to a faulty label.

You can find details of any medicines that have been recalled at the System for Australian Recall Actions database.

Medicines bought over the internet aren’t regulated by the TGA. Overseas recalls are often made available online by international agencies.

What to do if your medicine has been recalled

The first thing to do is talk to your doctor or pharmacist. They will tell you whether you can take a replacement medicine, or if it is okay to stop taking the medicine.

You should return the product to the place you bought it from as soon as you can. Then you can get a replacement or refund.

Even if you don’t require a replacement it’s important to dispose of unwanted medicines responsibly.

Making a report

If you have worries about a medicine’s packaging or have had a side effect, you can report it online to the TGA.

For urgent medical help, call triple zero (000). The Poisons Information Centre is also available 24 hours a day on 13 11 26.

Looking for more medicine information?

healthdirect’s medicines section allows you to search for medicines by brand name or active ingredient. It provides useful information about medicines such as their use, whether they are available on the Pharmaceutical Benefits Scheme and product recalls.



Last reviewed: March 2016

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