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The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 1 recall notice for all batches of quetiapine oral suspension (Seroquel; Eaststone Limited), after the manufacturer warned that they contain twice as much quetiapine fumarate than they should.
In a national patient safety alert, issued on 29 January 2026, the MHRA said that 166 affected products — produced between 26 October 2025 and 26 January 2026 — were distributed.
Quetiapine is an antipsychotic used in schizophrenia, bipolar disorder and as an adjunctive treatment in major depression. The drug is also provided as an unlicensed special medicine.
Eaststone Limited confirmed that it can identify all healthcare customers who received the products, the alert said, adding that it had initiated communication and recall actions.
The alert added that pharmacy teams are required to immediately stop supplying affected products, as well as quarantine and return any remaining stock.
It instructed pharmacy teams to identify and contact patients who have received any of the products and inform the patients’ GP — or other healthcare professional responsible for their care — that the patient may have taken twice the intended dose owing to a manufacturing error, which it said must be completed by February 2026.
The alert noted that affected patients may require plasma level monitoring and an ECG.
It said that patients should be provided with a treatment review, and advised of the symptoms of overdose.
If they experience any of these symptoms, patients should be advised to contact their healthcare team.
Alison Cave, chief safety officer at the MHRA, said that patients should not stop taking their medication until they have spoken to their doctor, because suddenly stopping antipsychotic medicine can cause severe side effects.
“Patients should be aware of the symptoms of overdose, which include extreme drowsiness, vomiting, dizziness or confusion, and slow or shallow breathing,” Cave said, adding that patients who experience any of these symptoms should seek immediate medical assistance or visit their nearest accident and emergency centre.
“Anyone who has questions about their medication should speak to their healthcare professional. We also encourage patients to report any suspected adverse reactions via the MHRA Yellow Card scheme.”
On 28 January 2026, a class 4 medicines notification was also issued for pre-filled syringes of antithrombotic agent Arixtra (fondaparinux sodium; Viatris), owing to brown discolouration and blockage in the needle.
While the MHRA said the occurrence of this defect is very rare — and the products are not being recalled as it is “critical to the continued supply of this medication” — the agency has asked healthcare professionals to inspect needles before dispensing and to return affected products to the supplier.
