Between January 30, 2025, and March 14, 2025, the company HLB Pharma distributed 210,000 vials of clinical fentanyl contaminated with bacteria in Argentine medical institutes. The drug was administered to hospitalized patients and caused the death of 90 people: from a seven-month-old baby in the city of Rosario to a 90-year-old woman in Santa Fe. The justice system has now determined that those who were then authorities of the body responsible for ensuring the safety of medicines had sufficient elements to suspect the risk and prevent the contaminated batches from being dispatched, yet they did not do so.
The Federal Prosecutor’s Office No. 1 of La Plata (a city 60 kilometers from Buenos Aires where most of the deaths occurred) ordered the arrest on Tuesday of Nélida Agustina Bisio, former head of the National Administration of Drugs, Food and Medical Technology (ANMAT), and Gabriela Mantecón Fumadó, former national director of the National Institute of Medicines (INAME), an agency operating under ANMAT. Both are accused of committing a crime against public health for poisoning, adulteration, or falsification of substances, which carries a penalty of up to 25 years in prison, and their situation could even worsen with a homicide charge.
Clinical fentanyl is a synthetic opioid one hundred times more potent than morphine, used as an anesthetic or analgesic in critically ill patients. When injected with the bacteria klebsiella pneumoniae and ralstonia mannitolilytica, the drug, instead of relieving pain, triggered respiratory diseases that ended up killing the patient. In addition to the 90 deceased, the supply of this medication caused an incurable disease or permanent disability for work in at least two people and life-threatening danger or work disability for more than a month in at least another 41. That is, the identified victims so far are 132, although there could be more.
The prosecutor’s report reveals that INAME technical staff submitted on January 3, 2025, to the authorities a project to issue a “warning letter” to Laboratorios Ramallo, which manufactured the products later marketed by HLB Pharma, and to withdraw several of its products from the market. While that document lay dormant in offices, at least 210,000 vials of contaminated fentanyl left the laboratory and were distributed in five different batches. The warning was only signed on February 10, when the first patient had already died, and the drug withdrawal occurred more than four months later, on May 8.
To justify her arrest request, prosecutor María Laura Roteta stated that the pharmaceutical laboratories HLB Pharma Group S.A. and Laboratorios Ramallo S.A., controlled by the García brothers’ family group, had a history of non-compliance and irregularities in good manufacturing practices of medicinal products that officials Bisio and Mantecón Fumadó were aware of.
The deficiencies had been verified by INAME during an inspection carried out at Laboratorios Ramallo between November and December 2024, shortly before the largest health tragedy investigated by the Argentine justice system broke out.
The poor conditions were even warned about when the company’s general director, Javier Tchukrán, was previously notified of the laboratory inspection and led an operation to correct the most noticeable shortcomings. “People should not be eating in the areas,” was one of the directives given by Tchukrán, according to the file.
For the Public Prosecutor’s Office, the history of serious non-compliance by the laboratory is explained by the existence of a “state cover-up” that allowed it to continue its productive activity in poor quality conditions. “It is proven that previously, during its preparation and in the course of the application of the contaminated fentanyl, the officials knew the high-risk scenario generated by the conditions in which both laboratories manufactured the drug and that deaths and injuries could be caused,” it details.
Bisio is a psychiatrist and joined ANMAT in the 1990s. In December 2023, she was appointed by Javier Milei as the main authority of the agency and resigned last January, one year after the contaminated fentanyl scandal. Mantecón Fumadó is a lawyer and had also been within the public agency for decades. She was put in charge of INAME in 2022, during Alberto Fernández’s presidency (2019-2023), and removed from her duties in August 2025, amid the progress of the judicial investigation.
The Argentine justice system had already prosecuted thirteen people last September. Among them are the brothers Ariel and Diego García Furfaro (owners of the laboratories); their mother, Nilda Furfaro (vice president and shareholder of HLB Pharma Group SA); the laboratory directors, Javier Martín Tchukrán, José Antonio Maiorano, and Carolina Ansaldi; and the quality managers: María Victoria García, Wilson Daniel Pons, Adriana Iúdica, Arzolidys Dayana Astudillo Bolívar, and Rocío del Cielo Garay. The list is completed by Edgardo Gerardo Antonio Sclafani and Eduardo Darchuk, who were in charge of production.
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