Xeal Pharma is recalling all strengths of Clopidogrel Oral Suspension and Clopidogrel Oral Solution products, as they contain less than the labelled amount of clopidogrel due to a formulation error.
The manufacturer has informed MHRA that the impacted batches contain only 76% of the required amount of clopidogrel, an anti-platelet drug, and it has invoked a Class 2 level recall involving patients, pharmacies and wholesalers.
Xeal said patient harm is not anticipated for those receiving the affected product for long-term preventative treatment, but they would not receive the full, prescribed dose.
Healthcare professionals should stop supplying the above batches immediately, quarantine the remaining stock and return it to their suppliers.
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.
They 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 their ongoing treatment.
As patients may require monitoring, other clinicians and healthcare professionals need to be involved.
Patients with impacted batches may require a dose correction, alternative licensed formulations or a different treatment option.
They should not stop taking clopidogrel without medical advice, as it may lead to serious thrombotic events.
The patients will be contacted by their GP, specialist, pharmacist, or other healthcare professional to make sure they get a new prescription for an alternative product.
Once they get a replacement, they should return the impacted product to pharmacy as part of the recall.
