How do I know if a product I bought is on the TGA's flagged list?

The TGA publishes safety alerts on its website at tga.gov.au — you can search by product name. If you are unsure whether a supplement or enhancement product is legitimately registered, check the Australian Register of Therapeutic Goods (ARTG) on the same site. A product that does not appear on the ARTG has not been assessed by the TGA for safety, quality, or content — regardless of how it is marketed or where it was purchased. Your pharmacist can also help you check and will accept unwanted medicines for safe disposal at no charge.

Why is sildenafil dangerous when taken with heart medicines?

Sildenafil and tadalafil work by relaxing smooth muscle in blood vessel walls, which increases blood flow. This mechanism overlaps dangerously with nitrate-based medicines prescribed for angina and certain heart conditions — including nitroglycerin and isosorbide preparations. When both are present in the body at the same time, the combined blood-vessel-dilating effect can cause a sudden, severe drop in blood pressure, which can lead to fainting, heart attack, or stroke. This interaction is well-established and is one of the main reasons these medicines require a GP or specialist consultation and a prescription before dispensing.

TGA finds hidden prescription drugs in sexual supplements

What just happened

The Therapeutic Goods Administration has flagged multiple sexual enhancement products sold in Australia as containing undeclared prescription medicines — including sildenafil and tadalafil, used to treat erectile dysfunction, and dapoxetine, which is used for premature ejaculation and is not approved for use in Australia.

Three separate TGA alerts cover a wide range of product formats: capsules, tablets, lozenges, creams, and — possibly most unexpectedly — honey sachets. Among the products named are Nano Volume capsules, Gold Lion tablets, Cobra Max capsules, Black Bull Extreme cream, and Grakcu capsules. The honey products include Black Horse Honey, Royal Honey VIP, Vital Honey, Helmi’s Honey, and Etumax Royal Honey.

The TGA has classified all flagged products as counterfeit under the Therapeutic Goods Act 1989 and is co-operating with Australian Border Force to prevent further importation. Anyone who has used these products is advised to stop immediately and dispose of them at a pharmacy.

The detail that lifts this beyond a standard product recall is what the hidden medicines actually are — and what they can do when a person takes them without knowing.

The both-and

”Natural” product, prescription pharmacology

Sildenafil and tadalafil are phosphodiesterase type 5 (PDE5) inhibitors. They work by relaxing smooth muscle in blood vessel walls, increasing arterial blood flow. In registered medicines, they are dispensed with specific prescribing information, contraindication warnings, and pharmacist counselling precisely because they have potent cardiovascular effects.

The TGA’s specific concern about Grakcu capsules is that they were found to contain two PDE5 inhibitors simultaneously — which compounds the cardiovascular risk beyond what either drug would carry alone.

PDE5 inhibitors combined with nitrate-based medicines — prescribed for angina and heart conditions, including nitroglycerin preparations and isosorbide mononitrate — can cause a sudden, severe, and potentially fatal drop in blood pressure. This interaction is one of the most consistently documented drug-drug interactions in cardiovascular medicine. It is the reason why a legitimate PDE5 prescription in Australia requires a consultation, a medical history review, and a pharmacist dispensing conversation that explicitly covers contraindications.

The products the TGA has flagged bypass all of that. They are sold as food products or “natural supplements” — not therapeutic goods. They do not appear on the Australian Register of Therapeutic Goods (ARTG). The person buying them has no way of knowing what is in them.

Dapoxetine adds a different layer. It is not approved in Australia, which means there is no authorised prescribing information for Australian clinicians to refer to. A patient presenting with an adverse reaction to an unlisted substance in an unlabelled product is a genuinely difficult clinical scenario.

The pattern this fits

The TGA has issued warnings about adulterated sexual enhancement products at regular intervals for at least a decade. Products appear in international online markets and through informal channels — weekend markets, social media sales, gift packages. When one batch is recalled, similar products continue to circulate.

The products tend to be marketed on the specific basis of being “natural” or “herbal” — which trades on a widely held assumption that natural means safe. For people who are embarrassed enough about the symptom they’re trying to address that they prefer not to raise it with a GP, an unregulated supplement feels like a lower-barrier option. That is exactly the population most likely to be buying these products without realising they are taking prescription medicines.

The population most at risk from the cardiovascular interaction is people who are older, male, and managing both erectile dysfunction and cardiovascular disease — a very common combination. Erectile dysfunction is itself an established early marker of cardiovascular risk; men presenting with it in general practice often have concurrent hypertension, dyslipidaemia, or established coronary artery disease. The same men are likely to be on nitrates or antihypertensives. The same men are least likely to mention over the counter supplements in a consultation unless asked.

What makes this harder to catch

Adverse reactions from undeclared PDE5 inhibitors may not immediately suggest a drug source. Dizziness, flushing, sudden chest discomfort, or syncope in a man with known cardiovascular disease has a large differential. “Did you take any supplements or enhancement products recently” is not a routine line in most acute assessments.

The history question is the access point. If it gets asked, the patient can connect the dots. If it doesn’t, the source of the interaction remains obscure.

2 cents

If anyone in your household has used any of the named products, the TGA’s advice is clear: stop and dispose of them through a pharmacy. Pharmacies accept unwanted medicines for safe disposal without charge or judgement.

If you’re not sure whether a product is legitimately registered, the ARTG can be searched at tga.gov.au. A supplement or enhancement product not listed on the ARTG has not been assessed for safety — the label’s claims about what is (or isn’t) in it carry no regulatory weight.

For anyone currently taking nitrate-based medicines for a heart condition, the undeclared drug interaction risk described here is not theoretical. It is a clinically established cardiovascular danger. If you or a partner has been using any unregistered enhancement product and are on heart medicines, speaking to your GP or pharmacist before taking anything further is the right move.

Verdict: yes — a public-safety issue with clear and immediate action items for patients, households, and general practice.

Sources cited

Medical Republic — Hidden drugs found in multiple sexual enhancement products (10 July 2026). https://www.medicalrepublic.com.au/hidden-drugs-found-in-multiple-sexual-enhancement-products/127229
TGA — Safety alerts and recalls. https://www.tga.gov.au/safety/alerts-and-recalls