Quality & complianceOfficial

MHRA recalls all Xeal Pharma clopidogrel oral liquids over 76% potency formulation error

🇬🇧 MHRA alerts · Mon 26 Oct 2026

A Class 2 recall covers every batch of the company's unlicensed clopidogrel oral solution and suspension produced before notification, with patients to be traced and reviewed.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall, reference EL(26)A/43, for all strengths of Xeal Pharma's Clopidogrel Oral Solution and Clopidogrel Oral Suspension. The notice was published on 26 October 2026. The company told the agency that the products contain less than the labelled amount of clopidogrel.

According to the notice, a formulation error means the affected batches contain 76% of the required amount of the active ingredient, clopidogrel hydrogen sulfate. All batches produced before the notification are affected. The products are unlicensed medicines (MS 46688), and the recall operates at patient, pharmacy and wholesaler level. The batch list is in Annex 1 to the notice.

Healthcare professionals are told to stop supplying the batches immediately, quarantine remaining stock and return it through their supplier's approved process. Pharmacists should identify and contact patients who were dispensed the product and ask whether they still hold any. Where batch traceability is unavailable, all patients dispensed the product from 20 July 2026 should be contacted. Those with affected product should be told it contained a lower dose than prescribed, and the pharmacist should contact the GP or prescriber to discuss ongoing treatment.

Xeal Pharma's risk assessment anticipates no patient harm in people taking the product for long-term preventative treatment, although they would not have received the full prescribed dose. No reports of patient harm have been received, and the recall is described as precautionary. Patients and carers are reminded that stopping clopidogrel suddenly may cause serious thrombotic events, and they should keep taking the medicine as advised until a replacement is available.

The MHRA notes that no licensed clopidogrel oral suspensions or solutions exist. Affected patients may therefore need a dose correction, an alternative licensed formulation or a different treatment. Xeal Pharma has confirmed that future stock will be made at the correct strength with correct calculations applied. Suspected adverse reactions should be reported through the Yellow Card scheme.

What it means for your team

  • Quality and supply-chain teams should quarantine and return all Xeal Pharma clopidogrel oral liquid stock and check Annex 1 for affected batches.
  • Pharmacovigilance teams should expect possible reports linked to under-dosing and should encourage Yellow Card reporting of suspected adverse reactions.
  • Pharmacies without batch traceability must contact all patients dispensed the product from 20 July 2026, so dispensing records matter.
  • Because no licensed oral liquid clopidogrel exists, prescribers face case-by-case decisions on dose correction or alternative therapy.

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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