Contaminated Medical Product Alert N°4/2025
FENTANILO HLB (fentanyl citrate) injection: contaminated product alert
WHO issued this alert after reports in May 2025 of a fatal outbreak of bacterial infections in Argentina. On 13 May 2025 the regulator ANMAT issued an alert and recall for lot 31202 after it tested positive for Klebsiella pneumoniae and Ralstonia pickettii. ANMAT had suspended manufacturing at LABORATORIOS RAMALLO S.A. on 24 February 2025 for good manufacturing practice deficiencies. WHO said circulation in other markets cannot be ruled out.1,2
- Issued
- 29 August 2025
- Issued by
- World Health Organization
- Name stated on packaging
- LABORATORIOS RAMALLO S.A. (Argentina), named in the alert as manufacturer, with HLB PHARMA GROUP S.A. as marketing authorisation holder
- Countries where detected
- Argentina
Batches named in the alert
31200, 31202, 31244, 31245, 31246, 31247
Advice as stated
Do not use these products. Treat injectable products from LABORATORIOS RAMALLO S.A. or HLB PHARMA made or distributed after February 2022 with caution. Report adverse events to the national regulator.
Names printed on falsified products are not evidence that the named company made them. Where WHO or a regulator reports the genuine manufacturer's statement, it is shown.
Sources
- World Health Organization, Medical Product Alert N°4/2025: Substandard (contaminated) FENTANILO HLB (fentanyl citrate) (29 August 2025)
- World Health Organization, Medical Product Alert N°4/2025: annex (PDF) (29 August 2025)