WHO Alert: Substandard Fentanilo HLB Products Linked to Fatal Infections
The World Health Organization (WHO) has issued an alert regarding six lots of substandard Fentanilo HLB (Fentanyl Citrate) detected in Argentina.
Fentanyl Citrate is a powerful opioid pain reliever used for managing pain during and after surgery, supporting mechanical ventilation, and treating chronic severe pain. In May 2025, a surge in fatal bacterial infections in Argentina was linked to contamination in lot 31202 of Fentanilo HLB injectable. This contamination involves drug-resistant bacteria: Klebsiella pneumoniae and ralstonia pickettii. Current details indicates multiple lots of Fentanilo HLB are affected and are subject to recall in Argentina.
these products are considered substandard as they fail to meet required quality standards, specifically regarding sterility. The WHO believes these fentanilo HLB products are contaminated with K. pneumoniae and/or R. pickettii.
Significant Risks
Use of these contaminated products poses a serious health risk to patients, potentially causing severe and fatal infections, notably in vulnerable individuals. Any use of these products carries a high risk.
recommendations:
Detection & Removal: It is indeed crucial to identify and remove these substandard products from circulation. Reporting: Healthcare professionals should report any detection of these products, or any adverse events potentially linked to them, to their national regulatory authorities or pharmacovigilance centers.
Increased Surveillance: The WHO recommends heightened surveillance and diligence throughout supply chains, especially in regions potentially affected. Strengthened monitoring of informal and unregulated markets is also advised.
National Authorities: National regulatory and health authorities are urged to instantly notify the WHO if these products are found within their country.
