Argentina permanently revokes licenses of laboratories implicated in contaminated fentanyl case
Anmat stated that the evidence gathered creates a sufficiently founded basis to conclude that the quality controls of the firms lacked efficacy, safety and quality
Argentina’s National Administration of Drugs, Foods and Medical Devices (Anmat) permanently revoked the operating licenses of laboratories HLB Pharma and Laboratorios Ramallo, linked to the production of contaminated fentanyl that caused the deaths of at least 111 people between late 2024 and the first half of 2025, in one of the worst health tragedies in the country’s recent history.
The measure, formalized through resolution 1848/2026 published on Friday in the Official Gazette, closes the administrative process initiated in May 2025, when the regulatory agency had already ordered the suspension of both companies’ production activities and banned the use, distribution and sale of all their products.
In the resolution’s rationale, Anmat stated that the evidence gathered creates a sufficiently founded basis to conclude that the quality controls of the firms lacked efficacy, safety and quality, generating an evident risk to public health. The text warned that the situation entails a critical, significant and unavoidable risk capable of endangering the health of the population.
The agency further noted that neither company submitted plans to correct the irregularities detected, requested new inspections or challenged prior sanctions, and that both currently lack a responsible technical director. Product certificates were not eliminated but will remain active by court order as part of the ongoing criminal proceedings.
The case originated when two multidrug-resistant bacteria — including Klebsiella pneumoniae — were detected in sealed fentanyl ampoules manufactured by HLB Pharma, matching those found in patients who received the medication in intensive care units. The outbreak was first identified at the Hospital Italiano in La Plata and spread to more than twenty medical centers across the country.
The federal court in La Plata determined in January a total of 159 cases: 111 deaths and 48 infections. Seventeen people have been charged so far, including the laboratories’ owner, Ariel García Furfaro, his brother Diego Hernán García and their mother, Nilda Furfaro, along with employees of both companies.
Audits by the National Institute of Medicines (Iname) had revealed a sustained pattern of violations prior to the fentanyl outbreak: in February 2025, dopamine distribution was banned for lack of traceability; in April, propofol batches were recalled on suspicion of falsification; and cross-contamination was detected in diclofenac and morphine. Inspectors found that at least 69 batches of solutions had been packaged in unauthorized containers without process validation or stability studies.
The resolution will be communicated to health authorities in all provinces, the City of Buenos Aires and the National Institute of Medicines.
