MHRA Class 4 Medicines Defect Notification: Enalapril maleate/ Hydrochlorothiazide 20 mg/12.5 mg Tablets (Star Pharmaceuticals Ltd)

MHRA Class 4 Medicines Defect Notification: Enalapril maleate/ Hydrochlorothiazide 20 mg/12.5 mg Tablets (Star Pharmaceuticals Ltd)

Drug alert number: EL(26)A/48

Date issued: 12 November 2026

Star Pharmaceuticals Limited have informed the MHRA of a typographical error on the strength of hydrochlorothiazide printed on the front face of the carton which incorrectly states “12. mg” instead of “12.5 mg”.

DMRC reference number: DMRC- 41407584

Marketing Authorisation Holder: Star Pharmaceuticals Ltd

Medicine Details

Enalapril maleate/Hydrochlorothiazide 20 mg/12.5 mg Tablets (PL/PI: 20636/1651)

Active ingredient: enalapril maleate / hydrochlorothiazide

GTIN: 05050114165107

Affected Lot Batch Numbers

Background

Star Pharmaceuticals Limited have informed the MHRA of a typographical error on the strength of hydrochlorothiazide printed on the front face of the carton which incorrectly states “12. mg” instead of “12.5 mg”. The strength is correctly presented on all other faces of the carton, the leaflet and the blister foil. The volume of affected stock distributed to the UK market is 1740 packs.

Advice for Healthcare Professionals

Healthcare professionals are asked to note the information in this notification and should continue to dispense this product; the quality of the tablets is not impacted by this labelling defect.

The risk associated with the labelling error is considered low because no corresponding strengths of the enalapril maleate / hydrochlorothiazide combination where the hydrochlorothiazide strength is expressed as 12 mg exist.

Healthcare professionals are advised to reassure patients, if contacted, that the product is enalapril maleate 20 mg / hydrochlorothiazide 12.5 mg tablets as described in the Patient Information Leaflet.

View the full alert here.

Advice for Healthcare Professionals to Provide to Patients

Patients should continue to take this medication as prescribed. This does not affect the quality of the tablets.

If you are unsure or have any questions, please seek advice from your pharmacy or other healthcare professionals involved in your treatment.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Additional information

For all medical information enquiries and information on this product, please email info@drugsrus.co.uk or telephone 020 8423 2111.