Australia’s Therapeutic Goods Administration (TGA) has reported laboratory testing failures in four unapproved peptide products marketed under the Synedica brand. Testing found no detectable TB-500 in three formulations and identified lower-than-declared retatrutide content with significant variation between samples. The findings emerged from the regulator’s cooperation with New South Wales Police in an investigation into the alleged illegal manufacture and distribution of peptide products.

Laboratory testing reveals discrepancies in product composition

According to the TGA safety advisory published on 5 November 2026, laboratory analysis identified discrepancies between product labels and the actual contents of all four tested formulations.

The findings were as follows:

• Synedica BPC 157 & TB 500 (10 mg): No detectable TB-500 was found, despite the ingredient being declared on the label.
• Synedica KLOW (80 mg): No detectable TB-500 was identified. The product is labelled as containing GHK-Cu, BPC-157, TB-500, KPV and vitamin B12.
• Synedica BARBIE KLOW (100 mg): No detectable TB-500 was identified. Its declared formulation includes GHK-Cu, melanotan I, BPC-157, TB-500, KPV and vitamin B12.
• Synedica Retatrutide (10 mg): Testing found less retatrutide than declared on the label, with significant variation between samples.

The results demonstrate that the tested products did not consistently match their declared composition. The TGA warned that consumers cannot rely on product labels to establish which substances they are administering or in what quantities.

Regulatory concerns over unapproved peptide products

The TGA stated that Synedica products have not undergone the quality, safety and efficacy assessment required under Australian therapeutic goods legislation. Their manufacturing sites have also not been approved by the regulator.

Most peptide products, including BPC-157, TB-500 and melanotan I, are classified as prescription-only medicines in Australia.

The regulator also highlighted the specific status of retatrutide. The investigational drug remains under clinical development and has not been approved by the TGA or any comparable international regulator. The TGA warned that retatrutide products obtained outside an authorised clinical trial setting could be counterfeit and should not be used.

Professor Robyn Langham AM, TGA Chief Medical Adviser, warned that unapproved peptide products may cause serious adverse reactions, including anaphylaxis. She also stressed that unreliable product composition makes it impossible for consumers to know what substances they are injecting.

Cooperation with police and enforcement priorities

The products were identified through the TGA’s assistance to the NSW Police State Crime Command under Strike Force Antree, an investigation into the alleged illegal manufacture, supply and distribution of peptide products.

According to NSW Police, the investigation began in July 2026. On 24 July, strike force detectives executed a search crime scene warrant at a property in Shell Cove, where they discovered an alleged clandestine peptide manufacturing facility and large quantities of restricted substances.

On 4 November 2026, police announced that two men had been charged following the investigation. The inquiries remain ongoing.

The TGA has expanded its priority compliance focus areas to include unapproved peptide products, following increased detection of unlawful importation, supply and advertising.

Chris Bedford, Acting Deputy Secretary of the Department of Health, Disability and Ageing and head of the TGA, said the regulator would continue working with law enforcement and other partners to identify and disrupt unlawful supply activities.

Potential penalties under Australian legislation

The TGA reminded businesses and individuals that breaches of the Therapeutic Goods Act 1989 can result in substantial civil and criminal penalties.

The maximum penalties specified by the regulator include:

• Civil penalties: Up to AUD 1.82 million per breach for individuals and AUD 18.2 million per breach for corporations.
• Criminal penalties: Imprisonment for up to seven years.

The regulator also advised consumers who possess Synedica products to stop using them and return remaining vials to a community pharmacy for safe disposal through the Return Unwanted Medicines programme. Suspected adverse events should be reported to the TGA.

The case illustrates the importance of independent analytical verification of medicinal product composition, particularly where products are supplied outside established regulatory and manufacturing control systems.