2026 in Focus: Recalls Under Greater Scrutiny – The New Perception of Reputational Risk and the Changing Approach of Regulatory Authorities

Voluntary or regulator-mandated recalls of medicines and food products are now being addressed more rigorously by ANVISA, MAPA, and consumer protection authorities. This movement has increased the level of scrutiny applied to the conduct of regulated companies and has significantly expanded the visibility of these procedures. Reputational risk has therefore become increasingly important in this context.

Products such as food and medicines, given their intended direct consumption and their potential impact on human health, are subject to a strict legal framework requiring technical controls, appropriate labeling, responsible advertising, and clear instructions for use. They are also subject to rigorous quality and safety control and assurance processes and, in the case of medicines, efficacy requirements as well.

The regulatory activities of ANVISA and MAPA reinforce the effectiveness of consumer protection rules, primarily serving as preventive mechanisms for the collective protection of consumers’ health and safety, although these authorities also have powers to conduct enforcement activities and apply repressive mechanisms, such as recall procedures themselves (see RAMOS, Flávio Augusto Spegiorin. Saúde e segurança: o consumo e a publicidade de alimentos e medicamentos. In: Do papel ao algoritmo: 35 anos do CDC e o futuro das relações de consumo. São Paulo: Singular, 2025).

Reputational risk, previously perceived as an indirect or secondary consequence, has become a central element in recall management in recent months. The increasing attention from both specialized and general media outlets reinforces this scenario: media organizations, particularly online outlets, have begun to monitor and report recall-related news and information involving regulated products with increasing frequency. ANVISA itself has contributed to amplifying this information.

The Agency has begun highlighting certain cases through its official channels, including its website and the profiles of members of the institution, which naturally leads to immediate reproduction by various media outlets.

Despite the high number of recalls conducted, the cases receiving the greatest attention, including through ANVISA’s own channels, involve brands that are widely recognized in the Brazilian market. In addition, there is a clear trend toward greater visibility for food recalls, which currently receive more media attention than many medicine recalls.

This environment of widespread disclosure has transformed reputational risk into one of the most sensitive factors in companies’ management of recall actions. Accordingly, the way a company communicates — or should communicate — the event, both to the regulatory authority and to consumers, has begun to directly influence public perceptions of the quality and reliability of the brand.

While recalls have always required technical rigor and specialized legal support, the current context makes this need even more evident. Appropriate communication, both before and after the event, with ANVISA and the public is decisive for the effective management of voluntary and mandatory recall procedures and, notably, for mitigating reputational impacts that may compromise intangible assets built over many years by companies operating in the Brazilian market.

Alongside reputational risk, which has become significantly more important than it was in the past, companies should also pay attention to other developments that we, as specialists, have been monitoring.

The technical complexity of recalls has consistently increased, particularly with regard to ANVISA’s regulatory expectations. The Agency has begun requiring greater precision in defining the scope of the recall, identifying the affected batches, and providing the technical and health-related rationale supporting the measure.

More robust risk assessments, complete traceability documentation, and well-structured action plans are no longer differentiators; they have become essential requirements for the credibility of the procedure and are now subject to rigorous scrutiny. In this environment, generic or insufficient communications tend to generate additional questions from the health authority, prolonging the process and increasing the company’s exposure.

At the same time, expectations regarding communications directed at consumers have also evolved. The clarity, timeliness, and proportionality of messages are now assessed not only by ANVISA but also by consumer protection authorities.

In a high-visibility environment, the way a company structures its communications, balancing transparency with informational responsibility, directly influences public perceptions of the seriousness of the event and of the company’s approach to potential health risks. This communication dimension has become an inseparable part of recall management strategy.

This material is for informational purposes only and should not be used independently as a basis for decision-making. Specific legal advice may be provided by one of our attorneys. All copyrights are reserved by KESTENER VIEIRA TORRONTEGUY SPEGIORIN ADVOGADOS.