A medicine recall is when a medicine or therapeutic product is withdrawn from being sold; or sold with specific warnings due to concerns with it. It might be because of safety, quality, effectiveness, labelling or packaging of the medicine or product.
It could be because of a problem with the medicine itself, like unexpected side effects, or a problem with something unrelated to the medicine, such as a packaging or labelling mistake.
The Therapeutic Goods Administration (TGA) and pharmaceutical companies can recall medicines. The TGA is the government body responsible for medicine safety, so it can enforce a medicine recall, even if the company does not agree.
The TGA might order the pharmaceutical company to:
If there is an alert but you need to keep taking the medicine, your doctor or pharmacist can guide you on what to monitor and how to manage side effects.
You can find details of any medicines that have been recalled at the Recall actions database (Opens in new tab).
Medicines are made by pharmaceutical companies. Many of these companies are based overseas. Often medicines are sold through Australian branches of those companies and sometimes they are distributed through a business in Australia.
The Australian Government regulates medicines and health products through the Therapeutic Goods Administration (Opens in new tab), or TGA.
The TGA is responsible for the quality of all medicines with an AUST number on the label, and can recall these medicines if a problem is found. This is true for medicines made in Australia or overseas.
Medicines and medical devices that you buy over the internet that aren't regulated by the TGA cannot be recalled by the TGA.
The TGA regulates therapeutic goods including:
The first thing to do if you think your medicine or therapeutic product is recalled, is talk to your doctor or pharmacist. They will tell you if the recall relates to your product, as sometimes only a particular dose or batch number is involved in a recall.
They can advise you on if you should keep taking the medicine carefully, stop taking the medicine or take a different medicine.
You should also follow the information in the recall instructions. There will be contact details in this instruction for more information.
If you have worries about a medicine's packaging or have had a side effect, you can report it online (Opens in new tab) or by phone to the TGA.
If you have taken too much or the wrong medication, the Poisons Information Centre (Opens in new tab) is also available 24 hours a day on 13 11 26 (Opens in new tab).
To search medicines by active ingredient or brand name, use the healthdirect search feature. It provides useful information about medicines such as their use, whether they are available on the Pharmaceutical Benefits Scheme (Opens in new tab) and product recalls.
You can search for recalled medicines through the System for Australian Recall Actions (Opens in new tab).
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 (Opens in new tab) and product recalls.
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Last reviewed: September 2023
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