Johnson & Johnson Innovative Medicine is notifying healthcare professionals of a supply shortage of Topamax, Topimax, Epitomax, and Topamac (topiramate) film-coated tablets, following a routine assessment at a manufacturing site that identified a need to modify engineering controls and internal environmental technologies, resulting in a temporary production interruption. The shortage, which is not due to any safety, efficacy, or quality concerns, is expected to continue through the fourth quarter of 2026 and affects several EU countries including Austria, Belgium, Croatia, Cyprus, Germany, Hungary, Italy, Netherlands, Portugal, and Spain.
The European Medicines Agency (EMA) issued the medicine shortage communication on 29 June 2026, detailing mitigation measures. Johnson & Johnson is engaging with EMA and national competent authorities to manage the shortage. Healthcare professionals are advised to prioritise existing patients for whom no suitable alternatives exist, and to consider prescribing alternative topiramate formulations (such as generic tablets, hard capsules, sprinkle capsules, or oral solutions) or other medicines approved for the same indications. The affected products are used as monotherapy or adjunctive therapy for partial seizures and primary generalised tonic-clonic seizures in adults and children, and for migraine prophylaxis in adults.
The production interruption stems from targeted modifications that do not affect product quality or safety of products already on the market or finished inventory. Johnson & Johnson is working with regulators and supply partners to restore supply as quickly as possible. Healthcare professionals are encouraged to consult EMA's shortage catalogue, national shortage registers, or competent authorities for further guidance.