Two batches recalled: the drug that protects children's hearing during chemo
What happened
The UK's medicines regulator has recalled two batches of a medicine that protects children's hearing while they are having chemotherapy. The alert was issued today, Monday 12 October 2026, by the Medicines and Healthcare products Regulatory Agency, known as the MHRA. Its reference is EL(26)A/42. The medicine is called Pedmarqsi. It is a clear liquid given through a drip, and its active ingredient is sodium thiosulfate. It is made by Norgine Pharmaceuticals Limited. Two batches are being recalled: Batch 458273, expiry date 12/2026, first distributed on 9 January 2025. Batch 475287, expiry date 12/2026, first distributed on 25 September 2025. The reason is a risk of particulate matter. That means tiny solid bits may be floating in the liquid. Norgine found the risk during what the MHRA alert calls "routine stability investigations" - the regular checks a company runs on its own medicines to see how they hold up over time. No one has reported being harmed. The MHRA alert says no adverse reactions have been reported, that the problem is limited to these two batches, and that Norgine is still checking its other batches. Pharmacies and wholesalers have been told to stop supplying these two batches immediately, to put any remaining stock aside, and to send it back through their supplier's normal returns process. Two things are worth saying clearly, because they are easy to miss. First, this is a recall at pharmacy and wholesaler level, and the MHRA says no action is required by patients. Second, other batches of Pedmarqsi are still available, so hospitals can carry on treating children.
Why this matters
Cisplatin is one of the most useful chemotherapy drugs there is. It treats solid tumours in children very effectively. But it has a cruel side effect: it lingers in the inner ear and damages hearing, especially the ability to hear high sounds. That damage is permanent. For a child, losing hearing is not a small thing. It can affect speech, school and friendships for the rest of their life. Pedmarqsi is the medicine that reduces that risk. It is given as a 15-minute drip exactly six hours after the cisplatin - late enough that it does not blunt the chemotherapy's attack on the cancer, but soon enough to protect the ear. The National Institute for Health and Care Excellence, or NICE, recommended it for the NHS in England in January 2025. Cancer Research UK reported at the time that almost 60 children and teenagers a year, aged from one month to 17, were expected to be eligible. So this is a small group of patients, but the stakes for each of them are high. That is the honest reason a recall of two batches is worth reporting, even though no child has been harmed and no family needs to do anything. It is also worth noticing what the recall says about the system. Nobody was hurt. No doctor spotted a problem in a child. The company's own routine testing flagged a risk, and the regulator acted on the same day it was told. That is the system working the way it is supposed to.
What the evidence actually says
It helps to be precise about how serious this alert is, because recall notices can sound frightening when they are not. The MHRA sorts medicine recalls into classes. This one is a Class 2. Class 2 is used for what the regulator treats as a major defect - something that could cause harm, but is not life-threatening or serious. Class 2 recalls ask for action within 48 hours. The most urgent class, Class 1, is handled differently again and is issued as a National Patient Safety Alert. This is not one of those. So the honest summary is: a real problem, taken seriously, acted on quickly, with no evidence yet of anyone coming to harm. On what the medicine itself does, the evidence is genuinely good. The European Medicines Agency authorises Pedmarqsi "for the prevention of ototoxicity induced by cisplatin chemotherapy" in patients aged one month to under 18 with localised, non-metastatic solid tumours. "Ototoxicity" simply means damage to the ear caused by a medicine. The main trial was called SIOPEL 6. Cancer Research UK reports that around 6 in 10 children treated with cisplatin alone go on to develop some permanent hearing loss, and that sodium thiosulfate almost halved the proportion of children who lost hearing. A separate trial in the United States and Canada found a similar reduction in a wider group of patients. Dr Penelope Brock, who led SIOPEL 6, called the NICE decision "crucial". One more detail from the alert matters, and it is reassuring. The MHRA tells staff to keep doing what the patient information leaflet already tells them to do: look at the vial before giving it, and check for particles and for any change in colour. In other words, there was already a check in place for exactly this kind of problem. The alert also confirms that inline filters - small filters fitted into the drip line - may be used with this medicine.
Qurexa perspective
We handle prescription medicines every working day, so recalls are part of our world rather than a surprise. The part we would gently highlight is the unglamorous one: batch numbers. A recall almost never means "this medicine is dangerous". It nearly always means "these specific batches are being pulled, and the rest are fine". The difference between those two sentences is the difference between a family stopping a treatment that is protecting their child, and a family carrying on safely. That is why the small print on a box or a vial matters, and why pharmacy teams spend so much time on stock checks that nobody ever sees. For the families affected by this particular alert, there is genuinely nothing to do - this medicine is given in hospital, by hospital staff, from hospital stock. But the general habit is a good one for any medicine you keep at home: know what you are taking, keep it in its original packaging, and keep the leaflet.
Practical advice
If your child is having cisplatin chemotherapy and receiving Pedmarqsi, here is what this alert means for you. Carry on as planned. Do not cancel or delay an appointment because of this recall. Pedmarqsi is given in hospital from hospital stock, and other batches are still available. You do not need to check anything yourself. The MHRA has been clear that no patient action is required. The recall is aimed at pharmacies and wholesalers. If you are worried, ask your child's treatment team. They will know which stock their pharmacy holds. Asking is reasonable, and they would rather you asked than worried. If you think your child has had a side effect from any medicine, you can report it yourself through the MHRA's Yellow Card scheme at yellowcard.mhra.gov.uk. You do not need to be certain the medicine caused it. Reports from patients and families are taken seriously and are part of how problems like this one get found. For healthcare professionals, the alert asks you to stop supplying batches 458273 and 475287 immediately, quarantine remaining stock, and return it through your supplier's approved process. Keep inspecting vials visually for particulate matter and discolouration before administration, as the patient information leaflet instructs. Norgine's medical information team can be reached at [email protected] or on 01895 826606, and stock queries go to [email protected] or 01895 826600.
What to know
The MHRA issued a Class 2 medicines recall today, 12 October 2026, for two batches of Pedmarqsi 80 mg/mL solution for infusion: batch 458273 and batch 475287, both expiring 12/2026. The reason is a risk of particulate matter - tiny solid bits in the liquid - found during the company's own routine stability testing. No adverse reactions have been reported. The problem is limited to these two batches, and other batches of Pedmarqsi remain available. This is a recall at pharmacy and wholesaler level. No action is needed by patients or families. Pedmarqsi contains sodium thiosulfate and is used to reduce the risk of permanent hearing loss in children aged one month to under 18 who are having cisplatin chemotherapy for solid tumours that have not spread. It is given in hospital as a 15-minute drip, six hours after the cisplatin. If you are unsure about anything to do with your child's treatment, speak to their hospital team. Sources: MHRA (GOV.UK), "Class 2 Medicines Recall: Norgine Pharmaceuticals Limited, Pedmarqsi 80 mg/mL solution for infusion, EL(26)A/42", 12 October 2026, https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-norgine-pharmaceuticals-limited-pedmarqsi-80-mg-slash-ml-solution-for-infusion-el-26-a-slash-42 | European Medicines Agency, "Pedmarqsi" (EPAR, product information and authorised indication), https://www.ema.europa.eu/en/medicines/human/EPAR/pedmarqsi | Cancer Research UK, Tim Gunn, "NHS offers new drug to stop children and teens losing hearing after chemotherapy", 28 January 2025, https://news.cancerresearchuk.org/2025/01/28/nice-recommends-pedmarqsi-sodium-thiosulfate-nhs-england/ | European Pharmaceutical Review, "MHRA Class 2 medicine recalls" (on how the MHRA defines a Class 2 recall and its 48-hour action window), https://www.europeanpharmaceuticalreview.com/news/259005/mhra-class-2-medicine-recalls-may-june-2025/ This article is for general information and does not replace advice from a doctor, pharmacist or other qualified healthcare professional. If your child is having cancer treatment, always follow the guidance of their hospital team.
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