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On March 31, 2025, the Philippines Food and Drug Administration (FDA) released the draft of Guidelines on the Recall of Authorized Health Products Regulated by the Food and Drug Administration. Stakeholders can submit comments to [email protected] by May 2, 2025.1
In December 2023, the Philippines FDA launched a public consultation on the draft of Guidelines on the Recall of Health Products Regulated by the Food and Drug Administration, with the goal of improving public health and safety through an updated framework for recalling health products, including cosmetics. The 2025 draft, built upon this consultation, includes two key updates compared to the 2023 draft:
1. Enhanced Clarity and Transparency in Recall Procedures
The marketing authorization holder (MAH) shall ensure that health products in the Philippine market comply with the FDA's safety, efficacy, and quality standards. Products that fail to meet these standards and pose serious risks are subject to either a MAH-initiated/voluntary recall, or an FDA-ordered/mandatory recall.
The 2023 draft outlines the procedures for both types of recalls. Expanding on this, the 2025 draft includes two annexes with flowcharts illustrating the respective procedures, specifying the responsible subject, necessary actions, stakeholder interactions, and key timing points at each stage. This can help stakeholders better understand their responsibilities and required actions, enabling a faster and more effective response to recall triggers while minimizing risks to public health.
Moreover, the new draft specifies post-marketing surveillance activities that may trigger a mandatory recall, fostering transparency in the decision-making process. These activities may include, but are not limited to, the following:
Health product quality/complaints processing;
Adverse events monitoring and events-based surveillance response reports;
Sampling, testing, and verification of health products;
Post-licensing inspections, monitoring, and investigations;
Post-evaluation of acknowledged notifications;
Monitoring of advertisements and promotional materials;
Coordination with regulatory agencies and international partners;
Pharmacovigilance;
Defective product reports from reputable sources (e.g., ASEAN Post-Marketing Alert System or PMAS);
Product information file audits.
2. Refined Report and Communication Requirements for MAH
Under the 2023 draft, the MAH shall notify the FDA and submit a report within 24 hours upon identifying a recall situation. The reports shall be sent to the Food and Drug Action Center at [email protected], and copied to the Office of the Director General at [email protected]. The 2025 draft further specifies that the MAH shall also notify the relevant FDA Center overseeing the health product in question. For cosmetics-related recalls, reports shall additionally be sent to [email protected].
Beyond reporting to the regulatory authority, the 2023 draft requires that the MAH shall inform all relevant parties within the supply chain about the recall. The communications shall be clear, consistent, and accurate, ensuring a thorough understanding of the recall risks and the actions required to reduce them. The 2025 draft further refines communication timing, introducing differentiated requirements based on recall class. Specifically, for Class I recalls, the MAH shall notify all affected parties within 24 hours, and for Class II recalls, within 48 hours of identifying a risk of injury, illness, or gross deception, while copying the FDA. For Class III recalls, the MAH shall notify all affected parties within 72 hours of deciding to initiate the recall.
In addition to the two key updates outlined above, the 2025 draft incorporates several minor revisions, such as expanded definitions of terms, Modified description of recall types, and clarified product details for communication requirements. Full details can be found in the 2025 draft here.
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