Safety Alert Molnlycke Hibiwash 500ml Bottle 4% Chlorhexidine Gluconate Antiseptic DEC85030 (ICN 3296)

• On 23 March 2026 the MHRA issued a Class 2 Medicine Recall, DMRC- 38814497 regarding Hibiwash 500ml bottle 4% Chlorhexidine Gluconate Antiseptic DEC85030.
• Mölnlycke Health Care are recalling specific batches of Hibiwash due to microbial contamination at the manufacturing facility, following routine weekly microbiological monitoring.
• The microbial contamination has been identified as Burkholderia cepacian.
• The investigation is ongoing, and to date no Hibiwash products have been found to be contaminated, however the batches at risk of contamination are being recalled as a precaution to mitigate any risks to public health.
• The risk to the general public from Burkholderia cepacian is considered very low, but some patient groups (such as individuals with cystic fibrosis or awaiting lung transplant) are at potentially increased risk of developing infections.

Next Steps:

• Read and follow the full instructions in the supplier letter and share with all users of the affected products.
• Cease use and quarantine all affected lot numbers.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products for return, reason code seven Supplier recall. All products must be returned no later than Friday 17 April 2026.

NHSSC: 121

Alert:

• Molnlycke Health Care has issued a supplier letter to advise of a potential microbial contamination affecting specific batches of Hibiwash products.
• The supplier is collaborating closely with the MHRA to conduct a thorough investigation into this matter.
• As a precautionary measure, and until the investigation is fully concluded (about 4 weeks timeline), Mölnlycke requests that all customers immediately quarantine the affected batches.

Products Affected:

• There is one product affected.
• The product affected available via NHS Supply Chain:

• NHS Supply Chain has quarantined any affected stock held.
• Molnlycke is unable to fulfil any future orders with unaffected stock resulting in the affected product being suspended and unavailable to order.
• Potential indirect alternative products are available to order through our online catalogue:
  • DEC85031 – 125ml bottle 4% chlorhexidine gluconate antiseptic
  • DEC85032 – 250ml bottle 4% chlorhexidine gluconate antiseptic
  • MRB320 – 500ml bottle 4% chlorhexidine surgical scrub solution.
• Where potential alternatives are identified, Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.
• See our Downloads ▼ section to access the product listing for further information on the affected product and potential alternatives.

Next Steps:

• Read and follow the full instructions in the supplier letter and share with all users of the affected products.
• Identify and quarantine any affected batches found.
• We will update this ICN with further actions once advised by the supplier.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.