An unlicensed “special” medicine for the management of psychiatric conditions has been recalled due to the “active content being twice the amount it should be”, it was announced on January 29.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued the national patient safety alert for batches of quetiapine oral suspension as a “manufacturing error” means the extra amount of quetiapine fumarate “could potentially result in an overdose”.

The alert affects 166 bottles manufactured by Eaststone Limited between October 26, 2025, and January 26, 2026, across the12.5mg/5 ml, 25mg/5ml, 50mg/5ml, 100mg/5ml and 200mg/5ml medicines, and this includes both expired and not expired batches.

Read more: Second infant formula toxin recall by FSA this month

It said the chief, superintendent or responsible pharmacist should stop supplying the impacted batches “immediately” and then quarantine and return the batches to the supplier.

It added that pharmacy and other healthcare professionals who dispense these products are advised to “identify and immediately contact all affected patients to confirm if they have any remaining medicine”.

The manufacturer said they used an “incorrect” formula for these batches, and it had quarantined the remainder of bottles not distributed out.

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The medicines watchdog said: “Your pharmacist, GP/doctor, or other healthcare professional will contact you as soon as possible to consider review of your treatment” to discuss any potential side effects, ongoing monitoring and advising on switching to an alternative treatment.  

The MHRA safety officer Dr Alison Cave said it is important that “patients do not stop taking their medication until they have spoken to their doctor” as stopping antipsychotic medication carries “risks of severe side effects, including acute withdrawal syndromes or rapid relapse”.

“Patients should be aware of the symptoms of overdose, which include extreme drowsiness, vomiting, dizziness or confusion, and slow or shallow breathing,” she added.

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Quetiapine is used for the management of schizophrenia, bipolar disorder, and as an add-on treatment for depression where licensed options are not suitable for the patient. 

Manufacturer Eaststone Limited said it advised the MHRA it has “full traceability of healthcare customers they have supplied directly” to and it has “already initiated communications and recall action”.

It comes as Danone recalled one batch of infant formula over the presence of the toxin cereulide, following a contamination from the same supplier that forced Nestlé to issue a recall earlier this month.