Xeal Pharma’s clopidogrel oral suspension and solution were recalled on Monday after a formulation error left them with 76 per cent of the required amount of the drug.
The Medicines and Healthcare products Regulatory Agency (MHRA) said Xeal had told it that all strengths of both products contain less than the labelled amount, and that every batch produced before the notification is affected.
The recall, numbered EL(26)A/43, is Class 2 and applies at patient, pharmacy and wholesaler level. The notice sets a 48-hour deadline for action.
The products are unlicensed medicines (MS 46688) with the active ingredient clopidogrel hydrogen sulfate.
The batches are listed by strength and number in an annex covering 1mg/1ml oral suspension, 25mg/5ml oral solution and suspension, and 75mg/5ml oral solution and suspension, in pack sizes from 25ml to 500ml.
The MHRA said no licensed clopidogrel oral suspension or solution is available in the UK.
Pharmacists must stop supplying the batches immediately, quarantine remaining stock and return it through their supplier’s approved process. They are also asked to contact everyone dispensed the affected batches and check whether they still hold any.
Where batch traceability is not available, the MHRA said all patients dispensed the product from 20 July 2026 should be contacted.
Pharmacists who identify a patient with an affected product should contact the patient’s GP or prescriber to discuss ongoing treatment. Prescribers and other clinicians monitoring patients on the liquids are asked to contact patients or carers directly so that treatment is reviewed.
The MHRA said patients with affected batches may need a dose correction, an alternative licensed formulation or a different treatment.
The MHRA said patients should never stop taking medicines such as clopidogrel without medical advice, because suddenly stopping may cause serious thrombotic events. They should keep taking the medicine as advised until they have an alternative, then return the affected product to their pharmacy.
A GP, specialist, pharmacist or other healthcare professional will contact patients where a new prescription is needed. Anyone who experiences adverse reactions or has questions about the medication should seek medical attention, and suspected reactions can be reported through the MHRA Yellow Card scheme.
Based on Xeal’s own risk assessment, patient harm is not anticipated in people taking the affected product for long-term preventative treatment, although they would not receive the full prescribed dose. The MHRA said no reports of patient harm have been received and the recall is being carried out "out of an abundance of caution".
Xeal has confirmed that all future stock will be made with the correct strength and calculations applied. NHS regional teams have been asked to pass the notice to community pharmacists and dispensing GPs.
Earlier Class 2 recalls this year, according to the March safety roundup, include Hibiwash 500ml (EL(26)A/15, issued 23 March) and Ramipril 5mg capsules (EL(26)A/11, issued 6 March).
Enquiries about the product can be made to Xeal Pharma by telephone on 0121 3090067.