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TGA Safety Alert: Ayurvedic Tablets Contain High Heavy Metals

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Published December 10th, 2025
Detected March 12th, 2026
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Summary

The Therapeutic Goods Administration (TGA) has issued a safety alert regarding Kumar Kalyan Rasa tablets, an Ayurvedic medicine. Testing revealed extremely high concentrations of heavy metals, including mercury, lead, arsenic, and cadmium, posing serious health risks to consumers, particularly pregnant women and children. The TGA urges consumers to exercise extreme caution with such products.

What changed

The Therapeutic Goods Administration (TGA) has issued an urgent safety alert concerning Ayurvedic products labelled Kumar Kalyan Rasa, manufactured by Unjha Ayurvedic Pharmacy. Laboratory testing has confirmed that these tablets contain dangerously high levels of heavy metals, including mercury, lead, arsenic, and cadmium. The TGA states that these products have not been assessed for quality, safety, or efficacy as required under Australian legislation and that their place of manufacture is not approved.

Consumers are strongly advised not to take these tablets as they pose a serious risk to health, potentially leading to heavy metal poisoning with severe long-term effects, including organ damage and death. Pregnant women and children are at heightened risk. The TGA urges consumers to be extremely cautious when purchasing medicines from unknown overseas websites or digital platforms and to consult a health professional if they have concerns or are currently using such products.

What to do next

  1. Advise consumers not to take Kumar Kalyan Rasa tablets.
  2. Urge consumers to exercise extreme caution when purchasing medicines online or from unknown overseas sources.
  3. Recommend consumers consult a health professional if they have concerns or are using such products.

Source document (simplified)

Kumar Kalyan Rasa tablets (Ayurvedic medicine)

Safety advisory Published

10 December 2025

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We have tested an Ayurvedic product labelled Kumar Kalyan Rasa, manufactured by Unjha Ayurvedic Pharmacy and found that the tablets contain extremely high concentrations of heavy metals, including mercury, lead, arsenic, and cadmium.

If high levels of lead are present in products, taking them could result in lead poisoning. Lead poisoning is a serious condition that can cause long-term health effects up to and including organ damage and death. Pregnant women and children are at a great level of risk of lead poisoning.

Exposure to even small amounts of mercury may cause serious health problems, having toxic effects on the nervous, digestive and immune systems, and on lungs, kidneys, skin and eyes.

These Unjha branded Kumar Kalyan Rasa tablets have not been assessed by us for quality, safety or efficacy as required under Australian legislation and the place of manufacture is not approved by us.

We have previously issued safety advisories for other unregistered Ayurvedic products in 2020, 2022 and most recently in September 2025. Despite these warnings, we continue to intercept unregistered Ayurvedic medicines imported into Australia that contain dangerous levels of heavy metals and other controlled or prohibited ingredients.

We urge consumers to exercise extreme caution when purchasing medicines from unknown overseas websites, social media or other digital platforms.

Australians currently using products, particularly if obtained from overseas or online should  refer to the multiple safety alerts and advisories issued by the TGA and to speak with their health professional about the right option for their circumstance to ensure their safety.

Products purchased over the internet:

  • may be fake
  • may contain incorrect or undisclosed and harmful ingredients
  • may not meet the same standards of quality, safety and efficacy as those approved by the TGA 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 questions.

The decision to use any medicine should be made jointly by the prescribing medical practitioner and the patient (or caregiver). This includes a discussion of potential side effects and the risks associated with buying medicines and medical devices online and from overseas.

Importing and supplying any unregistered Ayurvedic products is illegal, even if they don’t contain prescription-only ingredients.

Regulation of Ayurvedic medicines in Australia

In Australia, Ayurvedic medicines are regulated as listed medicines (also known as complementary medicines) and must meet the same safety and quality standards as other medicines. They must not contain dangerous substances or heavy metals at levels that pose a risk to health.

Why choose regulated medicines

To confirm if a product is on the Australian Register of Therapeutic Goods (ARTG), check for an AUST R or AUST L number on the packaging. This number confirms that the medicine is included on the ARTG and meets Australian standards including:

  • the ingredients listed on the label are accurate
  • the claims made are not misleading
  • the product was manufactured under strict safety and quality standards. Products without an AUST R or AUST L may not meet Australian standards and pose potential health risks. Whether purchased online or from local retailers, they may be unsafe, ineffective or a waste of money.

For further information on how we regulate registered and listed medicines, visit the TGA website.

Information for consumers

  • Stop using Unjha branded Kumar Kalyan Rasa and take any remaining product to your local pharmacy for safe disposal.
  • If you have already taken any of this medicine, or any other Kumar Kalyan Rasa preparations seek medical advice from your doctor or contact the Poisons Information Centre on 13 11 26.
  • If you suspect you have had a side effect (also known as an adverse event) to this or a similar medicine, report it to the TGA.
  • If you are considering purchasing medicines from overseas watch this short video on the risks associated with buying medicines and medical devices online.

Information for health professionals

Health professionals also play a key role in identifying and managing the risks associated with unregistered Ayurvedic medicines. Health professionals should discuss with their patients potential side effects and risks associated with buying medicines and medical devices online and from overseas.

Health professionals are encouraged to report adverse events involving medicines, including unapproved medicines. These reports assist the TGA in identifying previously unknown side effects and other safety issues.

In January 2025, the Victorian Department of Health also published an updated health advisory in relation to Ayurvedic medicines containing lead, other heavy metals and scheduled poisons.

Action we are taking

The TGA continues to monitor signals relating to harmful unregistered products and will notify the Australian Border Force (ABF) to seize and destroy any risky products intercepted at the border.

Reporting problems

Consumers are advised that the TGA cannot provide advice about individual medical conditions. If you are concerned about a possible side effect associated with a medicine or vaccine, please speak with a health professional.

You are also encouraged to report the side effect to the TGA as this helps us monitor and respond to emerging safety concerns.

If you suspect non-compliance in relation to therapeutic goods, you can report a perceived breach or questionable practice online to the TGA.

We also encourage the reporting of non-compliant advertising.

| Phone: | 1800 020 653 |
| Online: | Report a problem or side effect |
| Email: | info@tga.gov.au |

Topics
- Safety monitoring and information
Product types
- Unapproved therapeutic goods

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
Various
Published
December 10th, 2025
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Consumers Food manufacturers Healthcare providers
Geographic scope
National (Australia)

Taxonomy

Primary area
Product Safety
Operational domain
Compliance
Topics
Ayurvedic Medicine Heavy Metals Consumer Health

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