Recall issued for blood thinner over formulation error

Home Clinical Cardiovascular Recall issued fo... Recall of the antiplatelet medicine , clopidogrel, has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA). The class 2 recall was issued after the marketing authorisation holder, Xeal Pharma, informed the MHRA that all strengths of its clopidogrel oral suspension and clopidogrel oral solution contain less than the labelled amount of clopidogrel.

Due to a formulation error, the MHRA said that the impacted batches contain 76% of the required amount of clopidogrel and are, therefore, being recalled. All batches produced prior to this notification are affected and are listed here in Annex 1 . Xeal Pharma have confirmed that all future stock will be manufactured with the correct strength and calculations applied.

Clopidogrel is an antiplatelet medicine that prevents platelets from sticking together and forming dangerous blood clots. 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.

Healthcare professionals are advised to stop supplying the affected batches immediately, quarantine all remaining stock and return it to their supplier using the supplier’s approved process. More from The Pharmacist Healthcare professionals should be aware that there are no licensed clopidogrel oral suspension and solutions available.

Patients with impacted batches may require a dose correction, alternative licensed formulations or a different treatment option. The MHRA notice stated that 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, pharmacists should contact all patients dispensed this product from 20 July 2026. 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. The notification also added that healthcare professionals involved in the prescribing or monitoring of patients who are using clopidogrel oral solution or suspension should contact their patients directly to ensure that their treatment is reviewed.

No reports of patient harm have been received regarding this issue and the recall is being undertaken out of an abundance of caution. Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .