On August 24, 2026, the Malaysia National Pharmaceutical Regulatory Agency (NPRA) issued a public announcement stating that a soothing cream had been found to contain the controlled medicinal ingredient Hydroquinone, and that the product's notification had been revoked by the Director of Pharmaceutical Services. The product is no longer permitted to be sold in Malaysia.
Regulatory Action
NPRA stated that the product's cosmetic notification has been revoked with immediate effect, and the product is no longer permitted to be sold in Malaysia. The Ministry of Health also reminded consumers not to purchase or use this product from any source or batch.
Why Is the Detection of Hydroquinone in a Cosmetic a Serious Concern?
Hydroquinone is not permitted for use in cosmetic formulations in Malaysia. Under the Control of Drugs and Cosmetics Regulations 1984, any product containing Hydroquinone is classified as a "medicine" and must first be registered with the Drug Control Authority (PBKD) before it may be marketed; selling it as a cosmetic constitutes an offence.
Hydroquinone is strictly controlled because its misuse without professional medical supervision may cause a range of adverse skin reactions, including:
- Redness, rashes or erythema on the area of application;
- Unintended changes in skin colour, including uneven pigmentation and abnormal darkening or lightening;
- Increased skin sensitivity (hypersensitivity reactions);
- Interference with the melanin production process ("depigmentation"), weakening the skin's natural protection against ultraviolet (UV) radiation;
- Reduced UV protection, thereby increasing the risk of UV damage and skin cancer.
Warning to Sellers and Distributors
NPRA requires all sellers and distributors involved with this product to cease the sale and distribution of the product immediately. Continued sale or distribution will constitute a breach of the Control of Drugs and Cosmetics Regulations 1984, and the responsible parties will be subject to the following administrative penalties:
- Individuals: a first offence is liable to a fine not exceeding RM25,000, or imprisonment not exceeding 3 years, or both; a subsequent offence is liable to a fine not exceeding RM50,000, or imprisonment not exceeding 5 years, or both.
- Companies: a first offence is liable to a fine of up to RM50,000; the maximum fine for a subsequent offence is increased to RM100,000.
CIRS Reminder
This incident once again reminds all companies, both local and foreign, selling cosmetics in Malaysia of the following:
1. Raw-material compliance self-review: Hydroquinone, Mercury, Retinoic acid and similar ingredients are prohibited/restricted substances for cosmetics in Malaysia. Compliance screening against the ASEAN Cosmetic Directive and Malaysian national regulations should be carried out at the formulation development stage;
2. Pre-market testing of finished products: For products with high-risk efficacy claims such as whitening, spot fading, anti-acne and anti-wrinkle, each batch should be tested for prohibited ingredients before being placed on the market.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Our Services
- Malaysia Cosmetic Notification
- Malaysia Local Company Authorization & License Holding Services
- Preparation and Compilation of Product Information File (PIF)
- Electronic Account Registration
- Formula and Packaging Review
- Product Testing Services
- Logistics and Customs Clearance
Further Information:
