Class 2 Medicines Recall: Xeal Pharma, Clopidogrel Oral Liquids (all strengths), EL(26)A/43

Clopidogrel Oral Solution, Clopidogrel Oral Suspension

Active Ingredient: clopidogrel hydrogen sulfate

For a list of defected batches, see Annex 1

Xeal Pharma have informed MHRA that all strengths of their Clopidogrel Oral Suspension and Clopidogrel Oral Solution products contain less than the labelled amount of clopidogrel. Due to a formulation error, the impacted batches contain 76% of the required amount of clopidogrel. All batches produced prior to this notification are affected. Please note this is a Class 2 Patient, Pharmacy and Wholesaler level recall.

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Based on the risk assessment by Xeal Pharma, patient harm is not anticipated in patients receiving the affected product for long-term preventative treatment. However, patients would not receive the full, prescribed dose.

Pharmacists should identify and immediately contact all patients who have been dispensed these batches and ask them to confirm if they have remaining stock within their possession. If batch traceability information is not available, all patients dispensed this product from 20 July 2026 should be contacted. Patients should be informed that the product contained a lower dose than prescribed and patients and carers should be reminded that suddenly stopping this medicine may cause serious thrombotic events. If the pharmacist identifies any patients with an impacted product, they should contact the patient’s GP or prescriber and discuss ongoing treatment for the patient. As patients may require monitoring, other clinicians and healthcare professionals may need to be involved.

Prescribers, clinicians, and other healthcare professionals involved in the prescribing/monitoring of patients who are using Clopidogrel Oral Solution or Suspension should contact their patients and/or carers directly to ensure that their treatment is reviewed.