The National Medical Products Administration (NMPA) of China issued a Class II recall of the cosmetic product Botanical Hydrating Serum produced by Hubei Yunmei Cosmetics Co., Ltd. in January 2025. It came because of quality monitoring pointing towards microbial contamination past safety levels for acceptable cosmetic products.

Recall Notice: China – Botanical Hydrating Serum

Recall , July 01, 2025

The National Medical Products Administration (NMPA) of China issued a Class II recall of the cosmetic product Botanical Hydrating Serum produced by Hubei Yunmei Cosmetics Co., Ltd. in January 2025. It came because of quality monitoring pointing towards microbial contamination past safety levels for acceptable cosmetic products.

Reason for the Advisory

The detected contamination was Pseudomonas aeruginosa, which is a gram-negative bacterium that may lead to serious skin infections, especially when applied in aqueous, non-sterile products such as moisturizing serums. The recall was initiated based on internal QC results and substantiated by post-market inspection by the NMPA.

Root Cause Analysis

The root cause investigation revealed:

  • Sanitization failures in the bottling and filling equipment
  • Poor validation of the preservative system
  • Inadequate environmental monitoring procedures
  • Inadequate microbial limit testing in pre-release QC
  • Five infected batches were distributed before the problem was discovered.

Description of the product

 

Brand: Hubei Yunmei Cosmetics Co., Ltd.

Product: Botanical Hydrating Serum

Type: Cosmeceutical, Water-Based Facial Serum

Contaminant: Pseudomonas aeruginosa

Manufacturing Date Range: September–November 2024

Recall Date: January 2025

Distribution: China domestic market (retail, online), export to selected Asian markets

Recall Classification: Class II Cosmetic Recall (NMPA)

Ref link :  https://www.cirs-group.com/en/cosmetics/cosmetic-sampling-inspection-data-and-information-sharing-for-december-2024

Botanical Hydrating Serum

Regulatory Action by NMPA

  • A complete product recall was ordered by the NMPA with compulsory public disclosure.
  • NMPA reaffirmed its zero-tolerance approach to P. aeruginosa in water-based cosmetics.
  • Hubei Yunmei Cosmetics was ordered to stop production pending GMP compliance revalidation.

Regulatory Insights and GMP Failures

The case prompted regulatory attention to:

  • Adherence to China’s Cosmetic Supervision and Administration Regulation (CSAR)
  • Preservative efficacy and PET validation
  • Environmental controls in cleanroom areas as a mandatory requirement
  • Microbial monitoring batch-wise prior to market release

Consumer Safety Advisory

Consumers who have bought this serum are recommended to:

  • Immediately discontinue use
  • Bring the product back to the place of purchase
  • If irritation, rashes, or infection symptoms occur, refer to a dermatologist
  • Report adverse events to the NMPA adverse event platform

FRL Commentary on Microbiological Compliance

We prevent such incidents from happening to your brand at Food Research Lab by providing:

  • Preservative Efficacy Testing (PET)
  • GMP auditing and root cause analysis
  • Environmental monitoring SOP development
  • Regulatory dossier preparation (NMPA, ASEAN, MFDS, EU)
  • Microbial limit and stability testing in accordance with ISO 17516

Conclusion – Enhancing Microbial Risk Controls in China’s Cosmetic Industry

This recall emphasizes the pivotal significance of preventive microbiological controls in skincare manufacturing. With China’s cosmetic regulation becoming tighter under CSAR, non-compliance will lead to loss of reputation and market access. Companies must embrace a risk-based safety system, with incorporation of GMP systems and real-time microbiological monitoring.

Collaborate with Food Research Lab to:

  • Conduct microbial and preservative testing
  • Verify packaging for microbial entry
  • Adhere to compliance requirements under CSAR, ASEAN, NMPA
  • Reduce recall risk with adequate GMP documentation