This alert of the World Health Organization (WHO) concerns six lots of fentanilo HLB (Fentanyl Citrate) of lower quality detected in Argentina.
Fentanyl citrate is an opioid analgesic used in injection to relieve pain during and after surgery. It is also used to reduce the respiratory frequency in patients who are under mechanical ventilation and to take care of intense pain in patients with chronic diseases. In May 2025, the WHO noted reports reporting an epidemic flambé of fatal bacterial infections in Argentina linked to a contaminated lot (lot 31202) of fentanilo HLB injectable. Contamination involves stumps of pharmacoresisting bacteria: Klebsiella pneumoniae and Ralstonia pickettii. The information available now the WHO indicates that several lots of fentanilo HLB is contaminated and is therefore the subject of a recall in Argentina. The products identified in this alert are considered to be of lower quality, because they do not meet quality standards and the required specifications. The sterility of Fetanilo HLB products identified in this WHO medical product alert is considered to be compromised because they can be contaminated by K. pneumoniae and/or R. Pickettii.
Significant risks
These contaminated products have significant risks for patients and can cause serious and potentially fatal infections, especially in vulnerable people. Any use of these products presents a high risk for patients. In order to protect patients, it is essential to detect and remove from circulation these lower quality products. Health professionals must point out the detection of these lower quality products and any incident linked to undesirable effects or the lack of expected effects to their national regulatory authorities or their national pharmacovigilance center. WHO recommends increasing surveillance and diligence within supply chains in countries and regions likely to be affected by these lower quality products. It is also advisable to strengthen surveillance in informal and unregulated markets. The national regulatory authorities/national health authorities are asked and the authorities responsible for ensuring compliance with the law to immediately inform the WHO if these products are detected in their country.
Fifonsi Cyrience Kougnande
