Levetiracetam Neuraxpharm granules: Class 4 notification on leaflet information
1 October 2026
On 1 October 2026 the MHRA published Class 4 Medicines Defect Notification EL(26)A/40 for Levetiracetam Neuraxpharm granules for oral solution in sachet. The marketing authorisation holder is Neuraxpharm UK Limited, and the notice carries the reference DMRC-40741691. It covers the 250mg, 500mg, 750mg, 1000mg and 1500mg sachets, each in packs of 60.
What the notice says
Neuraxpharm told the MHRA that a review of the Patient Information Leaflet and the Summary of Product Characteristics found discrepancies between its safety information and that of the reference product. The notice states that all currently available stock is affected.
It also says that the MHRA and the Department of Health and Social Care consider the granules critical for patients who cannot take tablet formulations, so the affected batches continue to be supplied without repackaging. A corrected leaflet is not yet available on the MHRA Products website.
The notice sets out information missing from the current leaflet. It includes the approved indication in infants from one month of age, SCN8A mutation-associated early-onset epilepsy, a possible predisposition of the Japanese population to neuroleptic malignant syndrome, obsessive-compulsive disorder as a very rare adverse reaction and multiorgan hypersensitivity reactions as a rare one.
Actions the notice sets out
The notice advises prescribers to continue to prescribe and dispense in line with the approved product information. For pharmacy teams, it advises reviewing the notice and taking it into account when dispensing. Where possible, patients should be given a copy of a supplementary letter with each dispensing. The notice says there is no expectation that patients be contacted retrospectively. Neuraxpharm will include the letter with future deliveries and will send hard copies on request.
Context
A Class 4 notification is a caution in use notice, not a recall. Our clobazam note explains the four MHRA notice classes.
The full notice, including the supplementary letter, is on GOV.UK.