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Manage a recall

Information for sponsors and manufacturers about how recalls are managed and what they need to do.

We have released a preview of the new Procedure for Recalls, Product Alerts and Product Corrections (PRAC) which will take effect in early March 2025. Please familiarise yourself with this new resource now.

Sponsors should continue to follow the Uniform Recall Procedure for Therapeutic Goods (URPTG) until we advise the precise date for when the URPTG will be replaced by the PRAC.

A recall action is taken to resolve a problem with a therapeutic good already supplied in the market for which there are deficiencies in relation to safety, quality, efficacy (performance) or presentation. 

The responsibility to carry out and report on recall actions within Australia belongs to the Australian sponsor, unless otherwise formally agreed with the manufacturer or other third parties.

Guidance and resources

  • Recall action templates

    Forms
    Templates to help you with your communications under the Uniform recall procedure for therapeutic goods (URPTG).

Overseas Recalls

Therapeutic goods included in the Australian Register of Therapeutic Goods (the Register) may be subject to recall actions overseas. We are informed of these overseas actions as part of our ongoing working relationship with international agencies and regulators of therapeutic goods. 

If impacted goods have been imported and distributed in Australia, we will assess whether the importer /sponsor is required to conduct a recall action in Australia. Such recall actions will appear in the SARA database two business days following our agreement of the recall action.

Contact details for enquiries about product recalls

If your enquiry is not about product recalls, see: Contact the TGA

Contact details
Emailrecalls@health.gov.au
Phone
  • 1800 020 512 (freecall within Australia)
  • +61 2 6289 4613
  • 0412 205 568 (after hours contact – for recall-related emergencies only)

Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:

  • TTY or computer with modem users: phone 1800 555 677 then ask for 1800 020 653
  • Speak and listen (speech to speech relay) users: phone 1800 555 727 then ask for 1800 020 653
Postal addressRecalls
Manufacturing Quality Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia
Street address
(for deliveries)		Therapeutic Goods Administration
27 Scherger Drive
Fairbairn ACT 2609

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