Quality & complianceOfficial

MHRA flags Class 4 packaging defect on Star Pharmaceuticals enalapril/hydrochlorothiazide tablets

🇬🇧 MHRA alerts · Thu 12 Nov 2026

A typographical error on the front of the carton misstates the hydrochlorothiazide strength as "12. mg"; the MHRA says the tablets are unaffected and supply should continue.

Star Pharmaceuticals Ltd has told the Medicines and Healthcare products Regulatory Agency (MHRA) about a labelling error on its Enalapril maleate/Hydrochlorothiazide 20 mg/12.5 mg Tablets. The front face of the carton gives the hydrochlorothiazide strength as "12. mg" rather than "12.5 mg". The agency issued the Class 4 Medicines Defect Notification, reference EL(26)A/48, on 12 November 2026.

The strength is stated correctly on all other faces of the carton, in the patient leaflet and on the blister foil. Four batches of 28-tablet packs are affected: Y018198 (expiry 30/06/2027), Y019635 (31/10/2027), C125483 (29/02/2028) and C135541 (30/11/2028). The product licence number is PLPI 20636/1651 and the GTIN is 05050114165107. Star Pharmaceuticals distributed 1,740 affected packs to the UK market.

The MHRA asks healthcare professionals to note the notification and to keep dispensing the product, as tablet quality is not affected. It rates the risk as low because no enalapril/hydrochlorothiazide combination exists in which the hydrochlorothiazide strength is expressed as 12 mg. If patients make contact, professionals are advised to reassure them that the product is enalapril maleate 20 mg/hydrochlorothiazide 12.5 mg, as described in the patient information leaflet.

Patients should carry on taking the medicine as prescribed and can ask their pharmacy or other treating professionals if unsure. Suspected adverse reactions should be reported through the MHRA Yellow Card scheme. NHS regional teams are asked to pass the notice on to community pharmacists and dispensing GP practices. Medical information enquiries go to info@drugsrus.co.uk or 020 8423 2111.

For context, Class 4 is the lowest tier of the MHRA's defect classification and signals caution in use rather than a recall.

What it means for your team

  • No recall or quarantine is required: the MHRA advises continued dispensing of all four affected batches.
  • Dispensing teams should be ready for patient queries about the "12. mg" wording and can point to the leaflet, blister foil and other carton faces, which are correct.
  • Quality and artwork teams may wish to review proof-checking controls for primary and secondary packaging, since a single carton face went out with an incomplete strength.
  • Any suspected adverse reactions should still be reported via Yellow Card.

Official source: MHRA alerts ↗

Article written by VigiEye from the official source (MHRA alerts). AI-assisted; check the source before acting.

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