Star Pharmaceuticals keeps enalapril combination in supply after carton strength misprint

Star Pharmaceuticals will not have to pull stock of its enalapril maleate/hydrochlorothiazide 20 mg/12.5 mg tablets after the UK regulator classed a carton printing slip as a Class 4 defect, the lowest tier in its system. The MHRA issued the notification (reference EL(26)A/48) on 12 November 2026, advising that supply carry on.

The fault is confined to the front face of the carton, where the hydrochlorothiazide strength is cut off after the decimal point and the "5" is missing. The correct strength appears on the other carton faces, in the patient leaflet and on the blister foil. The MHRA says the tablets themselves are unaffected.

Star Pharmaceuticals told the agency it distributed 1,740 affected packs of 28 tablets to the UK. They come from four batches: Y018198 (expiry 30 June 2027), Y019635 (31 October 2027), C125483 (29 February 2028) and C135541 (30 November 2028). The product licence is PLPI 20636/1651 and the GTIN is 05050114165107.

The regulator rates the risk as low, because no enalapril/hydrochlorothiazide product exists with a 12 mg hydrochlorothiazide strength. Pharmacists are asked to reassure any patients who ask that the product is 20 mg/12.5 mg, as the leaflet states. NHS regional teams are being asked to pass the notice to community pharmacies and dispensing GP practices. The notice does not give any financial figures or say what the correction will cost the company.