Double-strength antipsychotic medicine recalled due to risk of overdose

All batches of the antipsychotic medicine, quetiapine oral suspension, are being recalled as the active content is twice the amount that it should be which could lead to overdosing.

Eaststone Limited informed the Medicines and Healthcare products Regulatory Agency (MHRA) that the formula they have used to manufacture all batches of quetiapine oral suspension products is incorrect.

Due to this manufacturing error the medicine contains twice the amount of active ingredient (quetiapine fumarate) than it should which could lead to overdosing.

Healthcare professionals have been advised to stop supplying the impacted batch immediately, to quarantine all stock and return it to their supplier.

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The alert requires recall action by those working in ​primary and secondary care, specifically those involved in pharmacy services, including dispensing general practices and those involved in the prescribing for mental health conditions.

The MHRA said implementation should be coordinated by an executive leader, supported by chief pharmacists, as well as leaders in general practice and community pharmacy.

Healthcare professionals involved in dispensing medicinal products should identify and immediately contact all patients who have been dispensed the impacted products and ask them to confirm if they have remaining stock within their possession.

If product traceability information is not available, all patients dispensed this product since 26 October 2025 to 26 January 2026 should be contacted.

The affected batch numbers can be found in annex four of the recall document.

If a patient is identified with this product, dispensing healthcare professionals have also been asked to contact the patient’s nurse, GP or other healthcare professional responsible for the care of the patient and advise them that the patient may have taken twice the intended dose of quetiapine oral suspension.

Eaststone Limited have clarified that a total of 166 units/bottles were manufactured between 26 October 2025 and 26 January 2026 and distributed to healthcare customers.

The remainder of bottles have been quarantined and will not be supplied.

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Any patients who have already taken batches, including both expired and non-expired, should be reviewed.

As this is a specialist use product, patients may require plasma level monitoring and ECG and other clinicians and healthcare professionals may need to be involved in the patients review and to consider alternative treatment options, where appropriate.

They should also be aware of the symptoms of overdose such as extreme drowsiness, vomiting, dizziness or confusion, slow or shallow breathing.

Eaststone Limited have confirmed they can trace supply to all patients who have been provided with the impacted products.

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Patients have been advised not to stop any treatments without consulting their relevant healthcare professional and a treatment review should be initiated as soon as possible.

Withdrawal of antipsychotic drugs after long-term therapy should always be gradual and closely monitored to avoid the risk of acute withdrawal syndromes or rapid relapse. Patients should be monitored for two years after withdrawal of antipsychotic medication for signs and symptoms of relapse.

This article was first published by our sister title The Pharmacist