Class 2 Medicines : Norgine Pharmaceuticals Limited, Pedmarqsi 80
OFFICIAL-SOURCE RECALL · UNITED KINGDOM
Class 4 Medicines Defect Notification: Neuraxpharm UK Ltd, Tuzulby Recall: Neuraxpharm UK Ltd has informed
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CountryUnited KingdomPublishedJuly 23, 2026Last updatedJuly 23, 2026Official source last checkedSeptember 9, 2026 at 1:48 PM UTC
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Class 4 Medicines Defect Notification: Neuraxpharm UK Ltd, Tuzulby prolonged-release chewable tablets, EL(26)A/36
- Manufacturer
- See official notice
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
Neuraxpharm UK Ltd has informed the MHRA of missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for certain batches of Tuzulby prolonged release 20mg, 30mg and 40mg chewable tablets.
Hazard
Neuraxpharm UK Ltd has informed the MHRA of missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for certain batches of Tuzulby prolonged release 20mg, 30mg and 40mg chewable tablets.
What consumers should do
within the Summary of Product Characteristics and Patient Information Leaflet, specifically: Summary of Product Characteristics (SmPC) Section 4.8 - ’Respiratory, thoracic and mediastinal disorders’ with a frequency of ‘not known’ – Epistaxis . Patient Information Leaflet (PIL) Section 4 – ’Possible side effects’. Other side effects including the following, if they get serious, please tell your doctor or pharmacist: Not known (frequency cannot be estimated from the available data) – Nosebleed . Advice for Healthcare Professionals: Healthcare professionals are advised to be aware that epistaxis (nosebleed) is a recognised adverse reaction associated with Tuzulby prolonged release chewable tablets and has been added to the Summary of Product Characteristics and Patient Information Leaflet with a frequency of ‘not known’. Healthcare professionals should continue to prescribe and dispense Tuzulby prolonged release chewable tablets in accordance with the approved product information. Patients reporting epistaxis should be managed in accordance with routine clinical practice and the individual patient’s clinical circumstances. A corrected version of the Patient Information Leaflet , cont
Official recall notice
Class 4 Medicines Defect Notification: Neuraxpharm UK Ltd, Tuzulby prolonged-release chewable tablets, EL(26)A/36
Agency: Medicines and Healthcare products Regulatory Agency
Official publication date: July 23, 2026
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