The Medicines and Healthcare products Regulatory Agency (MHRA) had issued a Class 4 medicines defect notification for enalapril maleate/ hydrochlorothiazide 20 mg/12.5mg tablets manufactured by Star Pharmaceuticals Ltd.
The notification, EL(26)A/48, issued on 12 November 2026, concerns a typographical error on the front of the product carton, where the hydrochlorothiazide strength is incorrectly printed as “12mg” instead of “12.5 mg”.
The correct strength is displayed on all other faces of the carton, the patient information leaflet and the blister foil.
Four affected batches identified
The notification covers the following batches, each supplied in packs of 28 tablets:
Batch number Expiry date
Y018198 - 30 June 2027
Y019635 - 31 October 2027
C125483 - 29 February 2028
C135541 - 30 November 2028
A total of 1,740 affected packs have been distributed to the UK market.
Pharmacies advised to continue dispensing
The MHRA has assessed the risk associated with the labelling error as low, as no corresponding enalapril/hydrochlorothiazide combination strength containing 12mg of hydrochlorothiazide exists.
Healthcare professionals are advised to continue dispensing the affected product, as the quality of the tablets is not impacted by the defect.
Pharmacists should reassure patients who raise concerns that the medicine contains the correct strength of enalapril maleate 20 mg and hydrochlorothiazide 12.5mg.
Patients are also advised to continue taking their medication as prescribed. Any suspected adverse reactions should be reported through the MHRA Yellow Card scheme.
