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Unapproved Drugs has been detected in Caballux arnica gel.

February 27 2025

Explore Regulations & Risks

On February 21, 2025, the U.S. Food and Drug Administration (FDA) reported the detection of unapproved drugs in Caballux arnica gel. This incident originated in Italy and falls under the category of control, specifically concerning...

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On February 21, 2025, the U.S. Food and Drug Administration (FDA) reported the detection of unapproved drugs in Caballux arnica gel. This incident originated in Italy and falls under the category of control, specifically concerning contaminants.

The FDA's findings indicate that the presence of unapproved substances in the product raises significant safety concerns. The agency emphasizes the importance of regulatory compliance to ensure consumer safety and the integrity of marketed products.

Caballux arnica gel, typically used for its topical applications, is now subject to scrutiny due to this contamination issue. The FDA's investigation aims to address potential risks associated with the use of this product, informing consumers and stakeholders about the implications of the findings.

As this situation develops, the FDA continues to monitor the safety and compliance of products distributed in the market. Consumers are encouraged to stay informed about the latest updates regarding Caballux arnica gel and similar products.


  • Incident: Unapproved Drugs has been detected in Caballux arnica gel.
  • Date: 2025-02-21
  • Product: Caballux arnica gel
  • Market: Available to SGS Digicomply users only. Explore the platform (for enterprises, no individual plans)
  • Origin of issue: ITALY
  • Hazard: Available to SGS Digicomply users only. Explore the platform (for enterprises, no individual plans)
  • Incident Category: Control
  • Hazard Category: Contaminants
  • Source: U.S. Food and Drug Administration

For more detailed information about this and other similar incidents, with access to filtering options, historical data, and trend analysis, try the SGS Digicomply Food Safety Software. Explore SGS Digicomply Food Safety Intelligence Hub demos here. (for enterprises only, no individual plans)

Tags: Control, U.S. Food and Drug Administration, Italy, Contaminants, February 2025