RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Neuraxpharm UK Ltd, Tuzulby prolonged-release chewable tablets, EL(26)A/36
Read and act on the official notice on GOV.UK
Class 4 recall — Caution in use.
The MHRA uses Class 4 when:
Usually minor defects in packaging or other printed materials.
What all four recall classes mean
| Class | Action | The MHRA's definition |
|---|---|---|
| Class 1 | Immediate action | The defect presents a risk of death or disability. |
| Class 2 | Action within 48 hours | The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious. |
| Class 3 | Action within 5 days | The defect is unlikely to cause harm to the patient. |
| Class 4 this recall | Caution in use | Usually minor defects in packaging or other printed materials. |
A Class 1 recall usually comes with a National Patient Safety Alert. Source: MHRA, safety communications.
The MHRA's 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.
Affected batches
As listed by the MHRA, exactly as published. Always check against the GOV.UK notice before acting.
| Batch number | Expiry | Pack size | First distributed |
|---|---|---|---|
| Tuzulby 20 mg prolonged-release chewable tablets | |||
| 77951 | 08/2028 | 30 | 18/12/2025 |
| 79949 | 02/2029 | 30 | 22/06/2026 |
| Tuzulby 30 mg prolonged-release chewable tablets | |||
| 78001 | 08/2028 | 30 | 18/12/2025 |
| 79961 | 02/2029 | 30 | 22/06/2026 |
| Tuzulby 40 mg prolonged-release chewable tablets | |||
| 78011 | 08/2028 | 30 | 18/12/2025 |
| 79974 | 02/2029 | 30 | 22/06/2026 |
MHRA's audience tags: Dispensing GP practices, Pharmacy