Herbal Supplement Recalls: What Lead and Undeclared Drugs in Ayurvedic Products Reveal

What happened: the Rheumacare lead recall

On 22 December 2025, the US online seller Handelnine Global Limited, trading as Navafresh, announced a nationwide recall of two lots of Rheumacare Capsules, an Ayurvedic product made by Virgo UAP Pharma Pvt. Ltd. in India and promoted for joint pain. FDA testing had found lead at up to 11,100 ppm. The product had been sold nationwide through the company’s website, and the firm had received one adverse event complaint^[1].

The recall followed FDA action. A warning letter dated 17 November 2025 reported individual lead results of 9,588 to 11,124 ppm in the two lots^[2], and FDA’s consumer warning described a user with extremely elevated blood lead levels and told consumers not to use the product^[3].

Table 1. Rheumacare Capsules recall at a glance

The same failures in UAE notices

UAE authorities have acted on the same two failures. In November 2016 the Ministry of Health and Prevention (MOHAP) banned three products sold as herbal: TT, promoted for headache relief, which it said could raise lead levels in people under 18; Ultimate Body Tox, a weight-loss product found to contain sibutramine; and Vimax, a male enhancer found to contain undeclared tadalafil^[4]. In April 2019 MOHAP warned that a red yeast rice product promoted online to “unclog arteries” was not licensed and that its specifications were unknown^[5]. On 20 February 2026 the Emirates Drug Establishment (EDE) issued circulars recalling or banning supplements found on online platforms, including one with the unauthorised ingredient dimethylaminoethanol and one recalled after a US FDA contamination update^[6].

What the regulator established

FDA’s warning letter sets out four findings^[2]:

• The lead level. FDA’s own testing found 9,588 to 11,124 ppm lead. Measured against a permitted daily exposure of 5 µg/day, the letter says the product contained approximately 7,000 times the amount of lead otherwise indicative of harmful exposure.
• Misbranding. The label did not declare lead, and the product was dangerous to health when used as the labelling directed.
• Adulteration. The product was not made in conformity with current good manufacturing practice (CGMP).
• Unapproved drug status. Rheumacare and nine other products on the site were unapproved new drugs, several because of disease claims.

FDA’s consumer page adds that there are no FDA-approved Ayurvedic products and that heavy metal poisoning can cause high blood pressure, kidney injury, fatigue, gastrointestinal and neurological symptoms^[3].

What is still unknown

• The root cause. Neither the recall notice nor the warning letter says whether the lead was added deliberately as a processed mineral ingredient or entered as contamination^[1][2].
• The full extent of harm. One adverse event is reported; FDA gives no wider case count^[1][3].
• Other markets. We found no UAE or GCC notice naming Rheumacare in the EDE legislation and circular listings or in UAE news coverage (checked November 2026), so whether it reached Gulf buyers through online sales is not known.
• The 2016 UAE circulars. We could not retrieve the original MOHAP circulars; the product details here come from contemporaneous trade-press reporting^[4].

Risk analysis: why herbal supplement recalls keep recurring

Heavy metals in Ayurvedic products

The Rheumacare case is extreme but not isolated. In a JAMA study of 193 Ayurvedic medicines bought online, 20.7% contained detectable lead, mercury or arsenic. Rasa shastra products, which combine herbs with metals, minerals or gems, were more often affected than plant-only products (40.6% vs 17.1%), and 75% of the metal-containing products claimed good manufacturing practice^[7]. In 42 over-the-counter preparations from licensed shops in Chandigarh, heavy metals were found in every sample, and mercury exceeded the FAO/WHO limit in 29^[8]. An analysis of 15 Ras-family products from three manufacturers found mercury, lead and arsenic at up to roughly 4 to 10%, mainly as cinnabar, litharge and arsenic sulphide, with large differences between manufacturers^[9]. In New Zealand, Medsafe reported eight lead poisoning cases in a few months linked to unlabelled Ayurvedic tablets^[10].

Dose turns a ppm result into an exposure. At 11,100 ppm (µg/g), a hypothetical 500 mg capsule would carry about 5,550 µg of lead, against an ICH Q3D oral permitted daily exposure of 5 µg^[11] and a Dubai Municipality adult limit of 20 µg/day for health supplements^[12].

Undeclared drugs in “herbal” products

Hidden drugs follow a clear pattern. An analysis of FDA warnings from 2007 to 2016 found 776 adulterated supplements: 45.5% were marketed for sexual enhancement, 40.9% for weight loss and 11.9% for muscle building. Sildenafil was the most common adulterant in sexual enhancement products and sibutramine in weight-loss products, and 19 of 28 products warned about more than once contained new unapproved ingredients the second time^[13]. The UAE’s 2016 bans on sibutramine and tadalafil products fit that pattern^[4].

Some botanicals blur the line without any adulteration. EFSA notes that monacolin K, which occurs in red yeast rice, is identical to the cholesterol-lowering drug lovastatin^[14], which is why claims and classification decide how such a product is regulated.

Table 2. Risk pattern by failure type

What UAE rules require

Classification comes first, because it decides which rules apply. Dubai Municipality’s technical guideline for health supplements (Version 2, 4 May 2024) covers vitamins, minerals, botanicals and herbs in capsules, tablets, powders and liquids, but places Ayurvedic products, Chinese medicine and traditional medicine products, and products indicated for sexual enhancement, outside the health-supplement category^[12]. For products that are in scope, the guideline requires that a health supplement^[12]:

• contains no active substance other than those stated on the label;
• meets adult heavy-metal limits per day of intake: arsenic 10 µg, mercury 20 µg, lead 20 µg and cadmium 6 µg;
• contains none of the banned ingredients in Annex 3, which include ashwagandha, shilajit, Terminalia arjuna and DMAE;
• is registered in the Montaji system before it is imported or sold, with advertising pre-approved; and
• can be recalled by batch at the request of Dubai Municipality or another authority.

At federal level, the EDE’s marketing authorisation for healthcare products covers dietary supplements and herbal products. Applicants supply, among other documents, a halal certificate and a company statement that the product is free of hormones, heavy metals, antibiotics, steroids and other harmful substances^[15]. Buyers and retailers can check registration status in the EDE’s registered medical product directory^[16]. How these limits apply in practice, including converting a ppm result to µg/day, is worked through in our guide to supplement label claims and overage in the UAE.

Table 3. Elemental limits compared (µg/day)

The limit that binds is the one for the product’s classification and registering authority; the two sets are not interchangeable.

Lessons for brands: where the controls failed

Every recall in this article points to a control that was missing or did not work:

• A GMP claim is not evidence. Three in four metal-containing products in the JAMA study claimed GMP^[7], and FDA cited Rheumacare for CGMP failures^[2]. Ask for audit reports and batch data, not a certificate alone.
• Test the finished lot, not only the herb. Extraction and processing can concentrate metals, so test both the raw material and every finished lot for lead, cadmium, arsenic and mercury, usually by ICP-MS, and convert results to µg/day at the highest labelled dose.
• Screen for what should not be there. Identity tests confirm the right plant; only a targeted screen finds sildenafil, sibutramine or steroids. Our analysis of the WAP tainted supplement recall shows why both are needed, and our guide to standardised extract testing covers identity methods.
• Classify before you formulate. A product presented as Ayurvedic, or making a disease or sexual-enhancement claim, is outside Dubai’s health-supplement route^[12]. Our guide to herbal supplement claims in the UAE sets out what can be said.
• Watch the sales channel. UAE regulators have repeatedly acted on products found online^[5][6]. Keep distribution records and a withdrawal plan that can trace every batch.

Protecting a product before it ships

1. Qualify suppliers with audits, certificates of analysis and your own confirmatory testing.
2. Write limits into every specification: elemental limits per day for the target authority, microbial limits and identity.
3. Test raw material and every finished lot for the four toxic elements, and add a targeted drug screen for high-risk categories.
4. Register under the right route and keep label and advertising claims within it.
5. Keep batch records and a withdrawal plan ready before launch.

For the wider safety evidence on Ayurvedic nutraceuticals, see our Ayurvedic nutraceutical toxicity and safety guide; for the end-to-end process, see the herbal product development process.

Conclusion

Herbal supplement recalls are late signals of early failures. The Rheumacare recall, the UAE bans on products with hidden sibutramine and tadalafil and the recent EDE circulars all trace back to sourcing, manufacturing, testing or registration. Brands selling into the UAE avoid them by classifying the product correctly, setting per-day limits, testing every lot and keeping claims inside the registered route.

For brands & formulators

Food Research Lab, based in Chennai, India, helps brands prepare herbal and Ayurvedic-inspired supplements for the UAE. Our herbal formulation team builds specifications with per-day elemental limits, supplier qualification and identity checks into the formula. Heavy-metal testing by ICP-MS, targeted drug screens and stability studies are run or arranged through accredited partner laboratories. Our regulatory and scientific research team helps you classify the product and prepare the file for Dubai Municipality or the EDE; see also our UAE services.

Contact us with your formula, supplier CoAs and target market.

In this series

• Herbal supplement demand in the UAE: who is buying herbal and Ayurvedic supplements in the UAE and GCC.
• Curcumin bioavailability: the science of absorption formats, including turmeric with black pepper (cluster guide).
• Herbal supplement claims in the UAE: what the rules allow on labels and in advertising.
• Herbal extraction methods compared: maceration to supercritical CO₂.
• Herbal supplement recalls: what lead and undeclared drugs in Ayurvedic products reveal (you are here).
• Curcumin supplement registration in the UAE: a worked example from formula to dossier.
• Herbal formulations: FRL’s herbal product development service.

1. Handelnine Global Limited. (2025, December 22). Handelnine Global Limited d/b/a as Navafresh issues nationwide recall of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo), due to elevated lead levels [Company announcement]. U.S. Food and Drug Administration. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/handelnine-global-limited-dba-navafresh-issues-nationwide-recall-rheumacare-capsules-virgo-uap (cited for the product, lots, lead up to 11,100 ppm, distribution, one adverse event and dates)
2. U.S. Food and Drug Administration. (2025, November 17). Warning letter: Handelnine Global, LLC dba Navafresh (MARCS-CMS 716013). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/handelnine-global-llc-dba-navafresh-716013-11172025 (cited for lead results of 9,588 to 11,124 ppm, the 7,000-fold comparison with a 5 µg/day PDE, preliminary mercury, strychnine, brucine and arsenic findings, misbranding, CGMP and unapproved drug charges)
3. U.S. Food and Drug Administration. (2025). FDA warns about heavy metal poisoning associated with certain unapproved ayurvedic drug products (content current as of 2 December 2025). https://www.fda.gov/drugs/fraudulent-products/fda-warns-about-heavy-metal-poisoning-associated-certain-unapproved-ayurvedic-drug-products (cited for the adverse event report, no FDA-approved Ayurvedic products and symptoms of heavy metal poisoning)
4. Scattergood, G. (2016, November 22). UAE orders withdrawal of further three ‘herbal supplements’. NutraIngredients. https://www.nutraingredients.com/Article/2016/11/22/UAE-orders-withdrawal-of-further-three-herbal-supplements (cited for MOHAP’s 2016 ban of TT, Ultimate Body Tox with sibutramine and Vimax with undeclared tadalafil; trade-press report of the ministry announcement)
5. Gulf News. (2019, April 10). Beware of dietary supplement made from red rice yeast, warns UAE ministry. https://gulfnews.com/uae/beware-of-dietary-supplement-made-from-red-rice-yeast-warns-uae-ministry-1.63243169 (cited for MOHAP’s statement that the promoted red yeast rice product was not licensed and its specifications were unknown)
6. Hussein, Y. (2026, February 25). UAE authority recalls 3 food supplements, 1 medical product for safety reasons. Khaleej Times. https://www.khaleejtimes.com/uae/uae-withdraws-3-dietary-supplements-one-medical-product (cited for the EDE circulars of 20 February 2026 on supplements sold online, including DMAE and a recall following an FDA contamination update)
7. Saper, R. B., Phillips, R. S., Sehgal, A., Khouri, N., Davis, R. B., Paquin, J., Thuppil, V., & Kales, S. N. (2008). Lead, mercury, and arsenic in US- and Indian-manufactured Ayurvedic medicines sold via the Internet. JAMA, 300(8), 915–923. https://doi.org/10.1001/jama.300.8.915 (cited for 20.7% of 193 products containing metals, 40.6% vs 17.1% for rasa shastra vs other products, and 75% of metal-containing products claiming GMP)
8. Bhalla, A., & Pannu, A. K. (2022). Are Ayurvedic medications store house of heavy metals? Toxicology Research, 11(1), 179–183. https://doi.org/10.1093/toxres/tfab124 (cited for heavy metals in all 42 preparations analysed by ICP-MS and mercury above the FAO/WHO limit in 29)
9. Duggal, H., Singh, G., Kapil, A., Mehta, D., & Kumar, S. (2023). Elemental and chemical phase analyses of Ras-family Ayurvedic medicinal products. Biological Trace Element Research, 201(6), 3099–3116. https://doi.org/10.1007/s12011-022-03389-y (cited for mercury, lead and arsenic at up to about 4–10% in Ras-family products, their mineral phases and variation between manufacturers)
10. Medsafe, New Zealand Medicines and Medical Devices Safety Authority. (2024, March 4). Lead poisoning associated with Ayurvedic medicines [Alert]. https://medsafe.govt.nz/safety/Alerts/Ayurvedic_Medicines_Lead_Poisioning.asp (cited for eight notified lead poisoning cases linked to unlabelled Ayurvedic tablets)
11. International Council for Harmonisation. (2022). Guideline for elemental impurities Q3D(R2) (Step 4). https://database.ich.org/sites/default/files/Q3D-R2_Guideline_Step4_2022_0308.pdf (cited for oral permitted daily exposures: cadmium 5, lead 5, arsenic 15 and mercury 30 µg/day)
12. Dubai Municipality. (2024, May 4). Technical guidelines for health supplements (DM-HSD-GU29-TGHS2, Version 2.0). https://dmpmedia.dm.gov.ae/uploads/2024/07/DM-HSD-GU29-TGHS2_Technical-Guidelines-for-Health-Supplements_V2.pdf (cited for scope exclusions in §5.2, safety requirements in §6, Montaji registration and advertising approval in §8 and §11.2, recalls in §11.3, Annex 2 heavy-metal limits and Annex 3 banned ingredients)
13. Tucker, J., Fischer, T., Upjohn, L., Mazzera, D., & Kumar, M. (2018). Unapproved pharmaceutical ingredients included in dietary supplements associated with US Food and Drug Administration warnings. JAMA Network Open, 1(6), e183337. https://doi.org/10.1001/jamanetworkopen.2018.3337 (cited for 776 adulterated supplements in 2007–2016, the category split, the most common adulterants and repeat adulteration)
14. EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), Younes, M., Aggett, P., et al. (2018). Scientific opinion on the safety of monacolins in red yeast rice. EFSA Journal, 16(8), 5368. https://doi.org/10.2903/j.efsa.2018.5368 (cited for monacolin K being identical to lovastatin)
15. Emirates Drug Establishment. (n.d.). Issuance of marketing authorization for a healthcare product. Retrieved 11 November 2026, from https://www.ede.gov.ae/en/w/issuance-of-marketing-authorization-for-a-healthcare-product (cited for scope including dietary supplements and herbal products, the halal certificate and the statement that the product is free of heavy metals and other harmful substances)
16. Emirates Drug Establishment. (n.d.). Registered medical product directory. Retrieved 11 November 2026, from https://www.ede.gov.ae/en/drug-directory (cited for checking registration status)