Class 4 Medicines Defect Notification: Star Pharmaceuticals Ltd, Enalapril maleate/ Hydrochlorothiazide 20 mg/12.5 mg Tablets
- The problem
- 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”.
- What to do
- Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
DMRC reference number
DMRC-41407584
Marketing Authorisation Holder
Star Pharmaceuticals Ltd
Medicine Details
Enalapril maleate/Hydrochlorothiazide 20 mg/12.5 mg Tablets
PLPI: 20636/1651
Active ingredient: enalapril maleate / hydrochlorothiazide
GTIN: 05050114165107
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| Y018198 | 30/06/2027 | 28 | 22/09/2026 |
| Y019635 | 31/10/2027 | 28 | 05/12/2025 |
| C125483 | 29/02/2028 | 28 | 05/03/2026 |
| C135541 | 30/11/2028 | 28 | 08/06/2026 |
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.
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.
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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Updated 12 November 2026. This page summarises an official notice. Details can change – always follow the official notice.