FDA inspectors uncovered counterfeit and improperly stored anti-rabies vaccines in Aurora and Nueva Ecija following a rabies-related death, prompting immediate seizure and enforcement action. Authorities urge the public to get vaccines only from authorized facilities and report suspicious products to protect public health. (Jason de Asis)

BALER, Aurora — The Food and Drug Administration (FDA), through its Field Regulatory Operations Office – North Luzon Cluster, conducted an urgent enforcement operation on February 10, 2026 in Baler, Aurora following the rabies-related death of an eight-year-old patient, uncovering serious violations involving the sale, storage, and distribution of anti-rabies vaccines.

The operation, carried out in coordination with the Local Government Unit of Aurora and with the support of the Provincial Health Office, focused on drugstores located near Aurora Memorial Hospital where anti-rabies vaccines were reportedly purchased.

During the inspection, FDA regulatory and enforcement teams discovered suspected counterfeit anti-rabies vaccines labeled “Equirab,” bearing batch numbers previously flagged under FDA Advisory No. 2025-1415. The establishment involved failed to present valid procurement and distribution documents to prove the authenticity and traceability of the products.

Other drugstores holding valid FDA Licenses to Operate were also found dispensing vaccines despite lacking proper authorization to engage in vaccine dispensing activities.

Inspectors further documented critical cold chain violations, including the improper storage of vaccines in household refrigerators alongside non-pharmaceutical items—conditions that may compromise the safety, quality, and efficacy of the vaccines.

As an immediate measure, the FDA secured and sealed all vaccine stocks for product verification and regulatory action. Vaccines with batch numbers covered under the advisory were seized and confiscated.

The following day, February 11, urgent product traceability operations were conducted in Barangay Alua, San Isidro, Nueva Ecija, with assistance from the Criminal Investigation and Detection Group (CIDG) Nueva Ecija. The identified distributor was found to have committed multiple violations, including failure to present distribution records and the absence of appropriate cold storage equipment required for biological products such as vaccines.

The FDA emphasized that counterfeit or improperly stored vaccines pose significant health risks and may lead to treatment failure, severe complications, or even death.

Authorities are continuing coordination with law enforcement agencies, local government units, and partner institutions to prevent the circulation of counterfeit vaccines and ensure strict compliance with regulatory standards. The FDA urged the public to obtain vaccines only from authorized establishments, ensure that vaccinations are administered by qualified healthcare professionals, and immediately report any suspicious vaccine products, illegal sales, or unauthorized storage practices through ereport@fda.gov.ph.

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