Order or notice
US FDA import alerts and warnings on Indian ayurvedic products (2021 to 2026)
Last checked 10 October 2026
The US FDA's heavy-metals import alert 99-42 lists Baidyanath bati products (1 Apr 2021), Falcon System (8 May 2025) and Kerala Ayurveda's Guluchyadi Kwath (7 Apr 2026), and the FDA warned about Rheumacare on 2 Dec 2025; these are US border measures, not Indian actions.
- Classification
- Regulatory notice or advisory
- Decided by
- US Food and Drug Administration (not an Indian regulator)
- Reference
- US FDA Import Alert 99-42 (updated 22 Sep 2026); FDA warning of 2 Dec 2025
- Latest action
- 7 April 2026
- Last checked
- 10 October 2026
Photo: Ayurvedic herbs 02.jpg by Vis M (CC BY-SA 4.0). All photo credits.
US FDA Import Alert 99-42: foods and products with heavy metals
Scope. A record here does not by itself mean a product or company is unsafe or banned today. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.
Below: Blacklisted's explanationWe organise and explain what the document says. The document above is the authority.
Key facts
- Baidyanath
- Shree Baidyanath Ayurved Bhawan (two entities) and Allayurveda.com: 'bati products', lead and mercury, listed 1 Apr 2021
- Falcon
- Falcon System of Ayurvedic Products: lead, listed 8 May 2025
- Kerala Ayurveda
- Kerala Ayurveda Ltd, Guluchyadi Kwath: lead, listed 7 Apr 2026
- Rheumacare
- FDA warning of 2 Dec 2025: sold via NavaFresh.com; lead, mercury, arsenic, strychnine and brucine; manufacturer not named
- What an import alert means
- Goods are detained at the US border without physical examination
The US Food and Drug Administration keeps an import alert for foods and products with heavy metals (Import Alert 99-42). Its Indian ayurvedic entries are Shree Baidyanath Ayurved Bhawan (two entities) and Allayurveda.com, for 'bati products' with lead and mercury, listed 1 Apr 2021; Falcon System of Ayurvedic Products, for lead, listed 8 May 2025; and Kerala Ayurveda Ltd, for Guluchyadi Kwath with lead, listed 7 Apr 2026.
On 2 Dec 2025 the FDA also warned about a product called Rheumacare, sold through NavaFresh.com, reporting lead, mercury, arsenic, strychnine and brucine. The FDA did not name the manufacturer.
An import alert means a named firm's goods may be detained at the US border without physical examination. It is a US measure. We found no Indian regulator action on these products, and the alerts do not say that ayurvedic medicines in general contain heavy metals. A separate US alert for unapproved drugs (66-41) lists other Indian firms; see the Dabur page.
What this means for you
A US border matter
An import alert lets the US FDA detain a named firm's goods at the US border. It is not an Indian ban or recall, and it does not apply to goods sold in India.
Named firms, not the whole category
The alerts name particular firms and products. They do not say that ayurvedic medicines in general contain heavy metals.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Has India taken action on these products?
We found no Indian regulator action on the products named in the US alerts.
Official sources and primary records
- US FDA Import Alert 99-42: foods and products with heavy metalsRegulatorUS Food and Drug Administration · 22 September 2026
- FDA warns about heavy metal poisoning associated with certain unapproved ayurvedic drug productsRegulatorUS Food and Drug Administration · 2 December 2025
- US FDA import alerts: entries for IndiaRegulatorUS Food and Drug Administration · 9 October 2026
- US FDA Import Alert 66-41: unapproved drugsRegulatorUS Food and Drug Administration