Mölnlycke Hibiwash Recalled Over Microbial Contamination
Summary
Mölnlycke Health Care is recalling three batches of Hibiwash (batch numbers 5156042, 5156043, and 5156093) due to Burkholderia cepacia contamination detected during routine weekly monitoring at the manufacturing facility. The recall impacts approximately 50,000 units of the antimicrobial wash. No reports of patient harm have been received, and the action is precautionary. Healthcare professionals and retailers must stop supplying affected batches and return stock to suppliers; patients should check batch numbers and return impacted product to a pharmacy for safe disposal.
“If you have Hibiwash, check the packaging for batch numbers 5156042, 5156043 or 5156093 and stop using it.”
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
MHRA has issued a Class 2 precautionary recall for Hibiwash, an antimicrobial wash manufactured by Mölnlycke Health Care, following detection of Burkholderia cepacia contamination during routine monitoring. Three batches are affected: 5156042, 5156043, and 5156093. Although no patient harm has been reported, the contamination poses elevated risk to vulnerable populations including cystic fibrosis patients and lung transplant recipients.
Affected parties must take immediate action: healthcare professionals and retailers must cease supply and return remaining stock, while patients must check batch numbers and return impacted products to pharmacies. Patients in high-risk groups who received Hibiwash since 10 February 2026 will be contacted directly by their care team. Alternative chlorhexidine gluconate 4% washes are available and unaffected by this recall.
What to do next
- Healthcare professionals and retailers should stop supplying Hibiwash with batch numbers 5156042, 5156043, and 5156093 and return all remaining stock to suppliers.
- Patients should check for the batch number on the bottle and those who have an impacted batch of Hibiwash should stop using it.
- Patients with cystic fibrosis or who are awaiting lung transplant who have been supplied with Hibiwash since 10 February 2026 will be contacted directly.
Archived snapshot
Mar 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Press release
Precautionary recall of Hibiwash due to microbial contamination
As a precautionary measure, Mölnlycke Health Care is recalling three batches of Hibiwash, an antimicrobial wash, due to microbial contamination at the manufacturing facility.
From: Medicines and Healthcare products Regulatory Agency Published 23 March 2026
As a precautionary measure, Mölnlycke Health Care is recalling three batches of Hibiwash, an antimicrobial wash, due to microbial contamination at the manufacturing facility.
Contamination with Burkholderia cepacia was identified during routine weekly monitoring, but there have been no reports of patient harm.
The risk from Burkholderia cepacia is very low for most people, but some patient groups are at a higher risk and may be more vulnerable to infection. This includes patients who have cystic fibrosis or are awaiting lung transplant. There have currently been no confirmed cases of Burkholderia cepacia infection in patients from the affected batches.
Healthcare professionals and retailers should stop supplying Hibiwash with batch numbers 5156042, 5156043, and 5156093 and return all remaining stock to suppliers. Patients should check for the batch number on the bottle and those who have an impacted batch of Hibiwash should stop using it. Patients with cystic fibrosis or who are awaiting lung transplant who have been supplied with Hibiwash since 10 February 2026 will be contacted directly to check if they have an impacted batch. If you have not been contacted directly, then contact the team responsible for your care. .
Alternative chlorhexidine gluconate 4% washes are available and are not impacted by this recall.
Shareen Doak, Deputy Director, Benefit-Risk Evaluation, at the Medicines and Healthcare products Regulatory Agency (MHRA) said:
“If you have Hibiwash, check the packaging for batch numbers 5156042, 5156043 or 5156093 and stop using it. These batches could be contaminated with Burkholderia cepacia and should be taken to a pharmacy for safe disposal.
“Please be reassured that there have been no reports of patient harm associated with this microbial contamination, and this recall is being carried out as a precaution.
“If you have used the product and are concerned that you may be vulnerable to infection or have experienced an adverse reaction, please seek medical advice.
“Any suspected adverse reactions can be reported to the MHRA through the MHRA’s Yellow Card Scheme scheme.”
Notes to editors
- Please see MHRA’s Class 2 recall for further information.
- This recall impacts around 50,000 units of Hibiwash
- The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
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Published 23 March 2026
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