162 products recalled: Unprecedented quantity
Regarding the decision to recall and suspend the circulation of 162 cosmetic products distributed by MK Skincare Import-Export Production and Trading Service Company Limited - a unit in the Mailisa ecosystem - issued by the Department of Drug Administration (Ministry of Health) on November 25, 2025, many questions have been raised such as the mechanism for announcing cosmetics before and after inspection, creating large loopholes in management, making poor quality cosmetics easy to circulate. Inspection is mainly based on consumer feedback, lacking control before the product is launched on the market.
According to the decision of the Drug Administration, 80 receipts of declarations were revoked, corresponding to 162 cosmetic products suspended from circulation nationwide. The list includes many familiar lines on the market such as Doctor Magic, Maika Beauty or products under the MK brand.
The reason for the recall was clearly stated: MK Skincare could not present the Product Information Document (PIF) as prescribed. This is a mandatory document to prove the safety, quality and effectiveness of cosmetics before circulation.
All products with expiration date must be recalled, stored, and awaited for processing. Enterprises must notify the distribution system and send a recall report to the Drug Administration before December 15, 2025. Business establishments must immediately stop selling and using; in case of detecting signs of criminal violations, they will be transferred to the authorities.
This is considered the largest recall in the cosmetic sector in many years.
According to Article 11 of Circular 06/2011/TT-BYT, which regulates general regulations on cosmetic product information records, each cosmetic product when put into circulation on the market must have a Product Information Document (PIF - Product Information File) according to ASEAN's instructions kept at the address of the organization or individual responsible for putting the product on the market.
In other words, a cosmetic product information file (PIF) is a set of documents that contains all the information about cosmetic products.
According to regulations, all cosmetic products imported or circulating in Vietnam must have PIF records including full information: Ingredients, quality standards, safety data, performance assessment... This is a tool for management agencies to conduct post-inspections and verify product quality after the enterprise self-declared.
However, the incident at Mailisa beauty salon exposed a paradox: A business has hundreds of products in circulation but cannot provide PIF, until it is required during the investigation of violations related to smuggling.
Post-inspection loophole
According to the Department of Drug Administration, there are currently about 200,000 cosmetic products nationwide that have received declarations from nearly 2,500 facilities, of which 150,000 imported products are processed by the Department and 50,000 domestic products are received by the Departments of Health.
Product announcement activities are carried out in accordance with the provisions of the ASEAN Cosmetic Agreement and Circular 06/2011/TT-BYT. Accordingly, for imported cosmetics, businesses only need to submit documents online: Declaration form; Authorization letter of the manufacturer or product owner; Free circulation certificate (CFS). The responsibility for ensuring quality, safety and efficiency lies entirely with the organization in charge of the announcement.
Dr. Ta Manh Hung - Deputy Director of the Department of Drug Administration (Ministry of Health) said: Inspection and post-inspection activities are implemented according to the principle of risk management, but the number of facilities inspected is still small. Each year, the Department only inspects 2030 facilities, while local Departments of Health inspect about 300 facilities.
In 2024, the Department inspected 23 facilities and fined 2 units with a total amount of 255 million VND; the Inspectorate of the Ministry of Health fined 4 more facilities (350 million VND). By November 17, 2025, the Department had inspected 35 facilities, of which 23 were surprise inspected, and fined 11 units with a total amount of more than 1 billion VND.
In terms of quality, in 2025 alone, 9,296 products were suspended from circulation, their declarations were revoked or their own recalls were made by businesses - a figure that shows that the cosmetics market is still very complicated.
Dr. Hung commented that the Vietnamese cosmetics market, with a scale of 2.32.5 billion USD in 2024 and a growth of 1015%/year, is a fertile land for counterfeit goods. Along with the widespread situation of homemade cosmetics, handicraft business and consumers' subjective psychology, the pressure on management agencies is increasing.
According to Circular 06/2011/TT-BYT and Decree 117/2020/ND-CP (amended by Decree 124/2021/ND-CP), the Drug Administration has full authority to conduct post-inspections, inspections and handle violations in the cosmetic field.
However, in reality, many cases of cosmetic violations are only discovered after consumers have reported, at that time the authorities will step in to check, take samples and handle them.
A typical example is the case of MK Skincare Import-Export Production and Trading Services Company Limited. Since 2018, MK Skincare has had 162 announcement forms, of which 81 were received, effective until November 17, 2025. However, the Drug Administration of Vietnam has never received any feedback from the testing system or the Department of Health about the quality of these products.
This is related to the self-declaration mechanism: enterprises prepare documents on ingredients, quality standards, safety, etc., submit them to the management agency and receive the receipt number. Management agencies do not pre-assess product quality; inspection only takes place after circulation or when there is a reflection.
Dr. Ta Manh Hung believes that this is a big bottleneck in cosmetic management. He proposed building a stronger post-inspection system, increasing inspection frequency, especially for products at risk of violations; at the same time, increasing sanctions, building a transparent source database.
In addition to perfecting the legal framework, Mr. Hung emphasized the need to develop the domestic cosmetic industry, raise consumer awareness and strengthen coordination between the Ministry of Health and the Police, Industry and Trade, Customs, Market Management... to strictly control the production chain of "import - distribution - circulation".
