Keep taking it - but read the extra letter in the bag
What happened
On 1 October 2026 the Medicines and Healthcare products Regulatory Agency (MHRA) issued a Class 4 Medicines Defect Notification. It covers one product: Levetiracetam Neuraxpharm granules for oral solution in sachets, made by Neuraxpharm UK Limited. All five strengths are affected - 250mg, 500mg, 750mg, 1000mg and 1500mg. The named batches have expiry dates between January 2027 and June 2029. Levetiracetam is a medicine used to control seizures. The granules come in sachets and are stirred into a drink or soft food, which makes them useful for young children and for anyone who finds tablets hard to swallow. The problem is not the medicine itself. It is the leaflet inside the box. A review found that the patient information leaflet does not match the approved information for the reference product. Several pieces of safety information are missing. The notice has the reference EL(26)A/40. The MHRA's advice is clear and short: keep prescribing, keep dispensing, keep taking it. A supplementary letter setting out the missing information should be handed out with each pack.
Why this matters
A 'Class 4' notice sounds alarming. It is actually the mildest of the MHRA's defect classes. It means 'caution in use'. Nobody is being told to stop, and nothing is being recalled from pharmacy shelves. That distinction matters enormously for epilepsy. Stopping an anti-seizure medicine suddenly, or missing doses, can trigger seizures. For some people that is dangerous. So the single most important sentence in the whole notice is the one telling patients to carry on exactly as prescribed. But the leaflet still matters. For most families, that folded piece of paper is the only written safety information they ever see. If it is missing a warning, a parent may not know what to look out for. The missing items are not trivial. They include how the medicine is dosed in infants from one month of age, information about epilepsy linked to changes in the SCN8A gene, and warnings about rare but serious reactions. This is also a reminder that medicines regulation is boring on purpose. Someone compared two documents line by line, found a mismatch, and published it. That is the system working rather than failing.
What the evidence actually says
The MHRA notice lists what the leaflet leaves out. It is worth being precise, because precision is the whole point here. The approved information includes dosing for infants from one month old. It includes information relating to epilepsy associated with SCN8A gene changes. It notes that people of Japanese ancestry may be more prone to a rare reaction called neuroleptic malignant syndrome. It covers the risk of obsessive-compulsive symptoms. And it covers multiorgan hypersensitivity reactions, sometimes called DRESS. None of these are new findings about levetiracetam. They are already part of the medicine's approved safety information. The defect is that this particular leaflet did not carry them. For healthcare professionals, the MHRA says to keep prescribing and dispensing in line with the approved information, and to give out the supplementary letter with each product. There is no need to contact patients who have already received affected packs, unless they have symptoms. For patients, the advice is to continue taking the medicine as prescribed, and to seek medical advice if seizures change, if there are changes in behaviour or obsessive thoughts, or if there are signs of neuroleptic malignant syndrome or DRESS.
Qurexa perspective
We deliver prescription medicines, so this is close to home for us. A leaflet correction is exactly the kind of thing that gets lost between a hospital clinic, a GP surgery, a dispensing pharmacy and a front door. The medicine arrives. The box looks normal. The extra letter is the easiest thing in the world to miss, or to throw away with the packaging. So three things we think are worth doing, whoever supplies your medicines. Keep the paperwork that comes with a delivery until you have read it. If there is a loose letter in with a sachet medicine, it is there for a reason. If you are not sure whether your sachets are affected, ask your pharmacist rather than guessing from the box. They can check the batch number against the MHRA notice in a minute. And if you care for someone with epilepsy, know what their seizures normally look like. You are the person most likely to notice a change, and that is the trigger for getting advice.
Practical advice
Keep taking or giving the medicine exactly as prescribed. Do not skip doses or stop while you wait for advice. Check whether a supplementary letter came with your most recent supply. If it did, read it and keep it with the box. If you did not get one, ring your pharmacy. Ask them to check the batch number and to give you the letter. Know the warning signs that need prompt medical attention: seizures that change in pattern, frequency or severity; new or worsening changes in mood, behaviour or obsessive thoughts; a high temperature with muscle stiffness and confusion; or a widespread rash with fever and swollen glands. For the last two, seek urgent help. If the medicine is for a baby or young child, check the dose with your pharmacist or specialist nurse rather than relying on the leaflet in the box. And never change an epilepsy medicine, or swap between brands, without speaking to the prescriber first.
What to know
The MHRA has issued a Class 4 defect notification (EL(26)A/40) for Levetiracetam Neuraxpharm granules for oral solution in sachets, covering all five strengths. The medicine is fine. The patient information leaflet is missing several pieces of approved safety information, including infant dosing from one month, SCN8A-associated epilepsy, a possible higher risk of neuroleptic malignant syndrome in people of Japanese ancestry, obsessive-compulsive symptoms, and multiorgan hypersensitivity. Class 4 means 'caution in use', not a recall. Patients should keep taking the medicine as prescribed. Pharmacies should supply a supplementary letter with each pack. If in doubt, ask your pharmacist to check your batch number. Sources: MHRA (GOV.UK), 'Class 4 Medicines Defect Notification: Neuraxpharm UK Limited, Levetiracetam Neuraxpharm granules for oral solution in sachet, EL(26)A/40', 1 October 2026, https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-neuraxpharm-uk-limited-levetiracetam-neuraxpharm-granules-for-oral-solution-in-sachet-el-26-a-slash-40; MHRA (GOV.UK), 'Drug and device safety alerts, recalls and notifications', https://www.gov.uk/drug-device-alerts This article is for general information and does not replace advice from a doctor, pharmacist or other qualified healthcare professional.
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