Two former officials charged over contaminated fentanyl linked to 90 deaths in Argentina

Former Argentine medicines regulators Nélida Agustina Bisio and Gabriela Mantecón Fumadó have been charged in the investigation into contaminated fentanyl that caused at least 90 deaths in 2025.

The judge handling the case, Ernesto Kreplak, charged both women without ordering pretrial detention. He identified them as “criminally liable necessary participants in the adulteration of medicinal substances that resulted in the death of at least 90 people.” Another 43 people suffered serious harm.

Two batches of fentanyl ampoules contaminated with two highly resistant bacteria were administered to patients in intensive care units in different parts of Argentina between April and May 2025. The medication was produced by HLB Pharma Group S.A. and Laboratorios Ramallo S.A., which had a record of breaches and irregularities in manufacturing practices when the health crisis occurred.

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criminally liable necessary participants in the adulteration of medicinal substances that resulted in the death of at least 90 people

Kreplak said Bisio, who formerly headed the National Administration of Medicines, Food and Medical Technology, and Mantecón Fumadó, the former director of the National Institute of Medicines, knew what was happening at the laboratories. He said they failed to take timely corrective and punitive measures needed to protect public health.

Regarding Mantecón Fumadó, the judge described “constant conduct that continued over time, showing total tolerance toward the countless alerts and reports” about serious irregularities at both laboratories. He cited delays in ordering necessary inspections, failures to publish product recalls, and an informal channel allegedly used to negotiate or reach agreements with officials at the two sites. He said the failure by ANMAT, which operates under the Health Ministry and oversees INAME, to impose sanctions reflected state protection for the companies.

The ruling also ordered an asset freeze and an embargo for 500 billion pesos, reported as about $326,000. In August 2025, Kreplak removed the Health Ministry, then led by Mario Lugones, as a private complainant in the case. That month, the government dismissed Mantecón Fumadó, who had been appointed during Alberto Fernández’s presidency, while Bisio remained in office at that time.

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constant conduct that continued over time, showing total tolerance toward the countless alerts and reports