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.
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PageUnderstand how we work with sponsors and stakeholders to ensure that recall actions are successful, as well as how we categorise recall actions.
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Reference materialGuidance on procedure to undertake recalls and non-recall actions for therapeutic goods.
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PageLearn about SARA, the publicly searchable database where we publish information about recall actions involving therapeutic goods in the Australian market.
Guidance and resources
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FormsTemplates 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
| recalls@health.gov.au | |
| Phone |
Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
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| Postal address | Recalls 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 |