May 12th 2026

By Ailsa Colquhoun

Alert: loperamide hydrochloride 2mg orodispersible tablets (Milpharm Ltd)

MHRA has issued an alert for two batches of loperamide hydrochloride 2mg orodispersible tablets (Milpharm Ltd).

The affected batches are: 

Batch No. Expiry Date Pack Size First Distributed
25882X3 30/11/2029 12 orodispersible tablets 17/12/2025
25882X2 30/11/2029 6 orodispersible tablets 17/12/2025

Two errors in the Patient Information Leaflet have been identified: 

  • the PIL incorrectly instructs patients to swallow the tablets whole with a drink of water (the correct instruction for an orodispersible tablet is to place the tablet on the tongue and allow it to dissolve, without water. The carton (outer packaging) for both affected batches carries the correct orodispersible method of administration, substantially mitigating this discrepancy at the point of use.)
  • The PIL omits the entry “Burning or prickling sensation of the tongue” (rare, may affect up to 1 in 1,000 patients), a recognised local effect of the orodispersible formulation that is listed in the Imodium Instants reference PIL.

Dispensers are asked to share this information with patients, where appropriate. Patients do not need to return the medicine.  

For all medical information enquiries and information on this product, please email medinfo@aurobindo.com, or telephone 020 8845 8811.

For stock control enquiries please email customerservices.uk@aurobindo.com, or telephone 020 8845 8811.


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