Medicines defect noticeMHRA
Tuzulby prolonged-release chewable tablets defect notice over a labelling error
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.
Check your product
Only products that match these details are covered. Have your pack in front of you.
10 identifiers listed for this notice.
Tuzulby prolonged-release chewable tablets 30
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 77951
- 79949
- 78001
- 79961
- 78011
- 79974
- ExpiryOn the carton, blister or label.
- 08/2028
- 02/2029
- First distributedOn the product, its label or its packaging.
- 18/12/2025
- 22/06/2026
What to do now
A printing or labelling mistake affects some packs of Tuzulby prolonged-release chewable tablets.
- Keep taking your medicine unless a healthcare professional tells you otherwise.
- Check the batch number and expiry date on your pack against the list on this page.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.
An affected pack bought over the counter can be returned to where you bought it.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/36). Quoted as issued.
Summary
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.
The risk
DMRC reference number DMRC-40198117 Marketing Authorisation Holder
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 , containing the required information, is available on the MHRA Products website. Upon request, Neuraxpharm UK Ltd will provide hard copies of the updated PIL to wholesalers and pharmacies so that any packs can be supplemented with the correct PIL information. Updated Summary of Product Characteristics are also available for the 20mg , 30mg , and 40mg products.
The Patient Information Leaflet is being updated to include nosebleed (epistaxis) as a possible side effect. If you experience nosebleeds or have any concerns about your treatment, please speak to your doctor or pharmacist.
Patients should continue to take Tuzulby prolonged release chewable tablets as prescribed by their healthcare professional. Do not stop treatment without seeking medical advice. Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Advice for patients
The Patient Information Leaflet is being updated to include nosebleed (epistaxis) as a possible side effect. If you experience nosebleeds or have any concerns about your treatment, please speak to your doctor or pharmacist.
Patients should continue to take Tuzulby prolonged release chewable tablets as prescribed by their healthcare professional. Do not stop treatment without seeking medical advice. Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Open the MHRA notice
Questions
Why has Tuzulby prolonged-release chewable tablets been recalled?
A printing or labelling mistake affects some packs of Tuzulby prolonged-release chewable tablets. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
How do I know if my medicine is affected?
Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.
Do I need a new prescription?
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.