Bangkok: The FDA has issued an urgent order to stop using two popular brands of inhalers after finding that they contain microorganisms exceeding the standard, posing a health risk. Pharmacist Suphattra Bunserm, Secretary-General of the Food and Drug Administration (FDA), revealed that the FDA announced the results of the analysis of two brands of herbal inhalers that were found to be contaminated with microorganisms. The FDA would like to clarify that this operation stems from online media reports in May 2025 about the discovery of fungi in herbal inhalers that are harmful to the lungs. Therefore, samples of various brands of herbal inhalers were randomly collected from both distribution and manufacturing locations and sent to the Department of Medical Sciences for analysis to test for contamination with microorganisms, yeast, mold, and other pathogens. This was done using the criteria set out in the Ministry of Public Health’s announcement regarding standards, purity values, or other characteristics importa
nt to the quality of herbal products.
According to Thai News Agency, the analysis revealed that the Hong Thai brand, formula 2, and Chama Herb brand inhalers exceeded acceptable microbial limits. The Hong Thai inhaler, with drug registration number G 309/62, production batch 000332, was found to contain Clostridium perfringens, alongside other microbial contaminants and molds. The Chama Herb inhaler, with drug registration number G561/67, production batch NF 2522503001, was identified with airborne microorganisms exceeding the standard criteria.
The FDA has therefore announced the results of its analysis to the public, stating that both brands of herbal inhalers are considered substandard herbal products. Further analysis results will be announced in the future if other brands are found to be contaminated with pathogens exceeding the standard.
Contaminated microorganisms, molds, and yeasts exceeding the prescribed limits can negatively impact public health, particularly those at risk, those with weakened bodies, those with compromised immune systems, or the elderly. Inhaling mold spores and Clostridium perfringens can cause harm, such as respiratory infections, difficulty breathing, wheezing, coughing, and mouth and throat pain.
The FDA has ordered the company to stop selling the substandard batch, recall the product from the market, and destroy it. The company has also ordered a temporary halt to production until the manufacturer can investigate the cause of the microbial contamination, find a solution to prevent a recurrence, produce samples using the proposed solution, and re-submit samples for analysis to prove the effectiveness of the proposed solution.
The FDA Secretary-General emphasized that the analysis of substandard products is specific to the production lot/batch number that was found to be defective. Other production lots can still be sold and used normally. Therefore, the public should check their products to ensure they match the batch number that was warned. If the batch is defective, discontinue use immediately and contact the manufacturer to arrange a return. The public is urged not to panic but to exercise caution when purchasing products and monitor for any abnormalities before use. The FDA recommends three guidelines to ensure the public can safely use inhalers.