The Bhutanese Leading the way.
Bhutan’s Food and Drug Authority (BFDA) has warned the public, importers, distributors, pharmacies, and retail outlets against the use, sale, and distribution of the herbal product Hong Thai Herbal Inhaler Formula 2 after concerns emerged over microbial contamination that could pose potential health risks.
The BFDA advised all businesses involved in the supply chain to immediately stop selling and distributing the product and to submit all remaining stocks to the authority for safe disposal. Members of the public were also urged to discontinue use of the inhaler if it had already been purchased.
The warning follows findings of significant microbial contamination, including yeast, mold, and bacteria, detected in certain batches of the product. The contamination levels were reported to have exceeded safe limits, raising concerns over the safety of the inhaler for consumer use.
Phuntsho Om Namgyal, an importer in Thimphu said, “I usually import Hong Thai in small numbers since there isn’t a big market for Hong Thai in Bhutan. Sometimes I bring small batches with me when I visit Thailand myself and it’s the same for other importers as well. I did import a small amount of Hong Thai in 2025 but I’m not sure if it was the 0322 batch and it has long been sold.”
Chhimi Tandin, a shopkeeper in Thimphu said, “I have a few numbers of Hong Thai inhalers in my shop and I wasn’t aware of the issue that happened and I still have some of the same batch number in my shop. However now that I’m aware of the issue, I will have to ultimately dispose of it even if it will lead to a loss.”
The action in Bhutan comes amid similar developments internationally. A batch with lot number 0332, manufactured on December 9, 2024, was specifically identified by Thailand’s Food and Drug Administration after failing to meet required microbial safety standards. Broader recalls later followed.
The manufacturer clarified that the issue was confined to the single batch produced in December 2024 and that other production batches were unaffected and safe for sale. Reports suggesting a suspension of all manufacturing and sales were stated to be inaccurate, as the regulatory action applied only to the contaminated batch.
In October 2025, Thailand’s FDA had already recalled a batch of the popular herbal inhaler after it failed microbial contamination tests.
The product was also recalled in the United Arab Emirates, where the Emirates Drug Establishment (EDE) issued a recall on November 3, 2025. Following warnings from Thailand, the EDE tested all batches available in the UAE market. Laboratory analyses confirmed microbial contamination levels exceeding the permissible limits for inhalation products, as set by international pharmacopeial standards.
