Class 2 Medicines : Norgine Pharmaceuticals Limited, Pedmarqsi 80
OFFICIAL-SOURCE RECALL · UNITED KINGDOM
Class 4 Medicines Defect Notification: Milpharm Limited, Loperamide Recall: Milpharm Limited has identified
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CountryUnited KingdomPublishedMay 11, 2026Last updatedMay 11, 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: Milpharm Limited, Loperamide hydrochloride 2 mg Orodispersible Tablets, EL(26)A/23
- 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
Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets.
Hazard
Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets.
What consumers should do
s, and overdose information — is correctly reflected. No related adverse drug reactions or safety signals have been identified in the company pharmacovigilance database. Advice for Healthcare Professionals: Healthcare professionals are asked to note the PIL discrepancies described above for batches 25882X3 and 25882X2 of Loperamide hydrochloride 2 mg Orodispersible Tablets (PL 16363/0784) and share this information with patients, where appropriate. The correct administration instructions are printed on the carton. Milpharm Limited have confirmed that all future batches will be packed with the corrected PIL. Healthcare professionals should be aware that “burning or prickling sensation of the tongue” is a recognised rare local adverse effect (frequency up to 1 in 1,000) of the orodispersible formulation, even though it is not currently listed in the affected PIL. Should a patient report this symptom following administration, it should be considered a potential medication-related effect and managed accordingly. Advice for Patients: If you have been dispensed Loperamide hydrochloride 2 mg Orodispersible Tablets from batch 25882X3 (pack of 12) or batch 25882X2 (pack of 6), please note t
Official recall notice
Class 4 Medicines Defect Notification: Milpharm Limited, Loperamide hydrochloride 2 mg Orodispersible Tablets, EL(26)A/23
Agency: Medicines and Healthcare products Regulatory Agency
Official publication date: May 11, 2026
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