Counterfeit Botox vials detected

Consumers and health professionals should be aware that two unrelated cases of counterfeit injectable botulinum toxin products have been stopped at the Australian border. The counterfeit products were packaged to appear as genuine, branded, Botox products, manufactured by Allergan, an AbbVie company.

These injectable products may pose a serious risk to your health and should not be used. 

The counterfeit products were labelled as Botox, containing onabotulinumtoxinA and botulinum toxin type A. However, packaging inconsistencies were identified, including typographic errors like incorrect spacing, bolding and spelling mistakes. Additionally, the batch numbers C7211C4 and HA 33946 have been confirmed by AbbVie as not genuine. 

Consumers are advised that botulinum toxin products are prescription-only medicines in Australia.

The counterfeit products were purchased online from an overseas website and imported; they were not obtained from an Australian pharmacy.

While consumers who hold a valid prescription may lawfully import prescription-only medicines for personal use, counterfeit products cannot be imported under the Personal Importation Scheme, under any circumstances, even with a valid prescription. 

Knowingly importing, supplying and/or giving away counterfeit therapeutic goods is illegal and poses a significant public health and safety risk.

Counterfeit products have not been assessed by us for quality, safety or efficacy as required under Australian legislation. 

Consumers should be warned that manufacturers of counterfeit goods are producing products that, to the untrained eye, may appear legitimate, highlighting the need to purchase your medicines from legitimate sources.

We advise consumers to exercise extreme caution when purchasing medicines from unknown overseas websites. 

Products purchased over the internet:

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

For your safety, always buy medicines from reputable sources and consult your healthcare provider or local registered pharmacy if you have any concerns.

Information for consumers

• Counterfeit Allergan-branded Botox with batch numbers C7211C4 or HA 33946 should not be used. Take any remaining product to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of this product, consult your health care practitioner.
• If you suspect you have experienced a side effect (also known as an adverse event) from this or a similar medicine, report it to the TGA via the Adverse Event Reporting page.
  • If possible, keep the medicine as we may request it for testing.
• If you are considering purchasing medicines from overseas, watch this short video on the risks associated with buying medicines and medical devices online.

Additional safety information for health care professionals

• Patients seeking cosmetic injectables are at increased risk of adverse events when injected with products that have not been approved for supply in Australia.
• Only the approved supplier (sponsor), as entered on the Australia Register of Therapeutic Goods (ARTG), or their authorised agent, can lawfully import cosmetic injectables into Australia for commercial supply. This includes the sale, administration, or application in treatment.
• Cosmetic injectables imported for commercial supply must be the version manufactured and approved for the Australian market, not a parallel import. These products must be entered on the ARTG under the supplier’s name prior to importation unless, accessed lawfully via an unapproved product pathway such as the Special Access Scheme (SAS).
• Purchasing and administering counterfeit products puts your patients at risk.
• One of the known issues with parallel imports is that they may not be transported under appropriate cold chain storage protocols, which can compromise product viability. Internationally, this has been linked to acquired botulism infection as a severe adverse event following a cosmetic injection procedure.
• Always check the product for any signs of counterfeiting before using it.

Action we are taking

The TGA continues to check batch numbers of any products that may be subject to counterfeiting.

We will notify ABF to seize and destroy any of these products intercepted at the border.

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:

Counterfeit Botox vials.

Imported product A

Imported product B