RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Milpharm Limited, Loperamide hydrochloride 2 mg Orodispersible Tablets, EL(26)A/23
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
Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible 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 |
|---|---|---|---|
| Loperamide hydrochloride 2 mg Orodispersible Tablets | |||
| 25882X3 | 30/11/2029 | 12 orodispersible tablets | 17/12/2025 |
| 25882X2 | 30/11/2029 | 6 orodispersible tablets | 17/12/2025 |
MHRA's audience tags: Dispensing GP practices, Pharmacy