The UK medicines regulator has issued an urgent recall of all batches of quetiapine oral suspension made by Eaststone Limited after a serious manufacturing error was discovered that could place patients at risk of overdose.
The Medicines and Healthcare products Regulatory Agency (MHRA) confirmed that the affected medicine contains twice the intended amount of the active ingredient, quetiapine fumarate. This means patients taking the recalled batches may unknowingly receive a much higher dose than prescribed, increasing the risk of harmful side effects.
Quetiapine oral suspension is an unlicensed “special” medicine used in the treatment of serious mental health conditions such as schizophrenia and bipolar disorder, and in some cases as an additional treatment for depression when standard licensed options are unsuitable. The medicine is often prescribed to patients who require tailored formulations, including those with swallowing difficulties or complex clinical needs.
The recall affects 166 bottles manufactured between 26 October 2025 and 26 January 2026. Eaststone Limited has informed the MHRA that it has full traceability of the healthcare providers it supplied directly and has already begun contacting them to remove the affected products from use.
Patients, including those in Black and diaspora communities who are statistically more likely to face barriers in mental health care access, are being urged to check whether they have this medicine at home. The batch number and expiry date can be found on the bottle or dispensing label. Anyone who has not yet been contacted and believes they may have received the medicine is advised to speak to their GP, specialist or pharmacist as soon as possible.
Crucially, health officials are warning patients not to stop taking quetiapine suddenly without medical advice. Dr Alison Cave, the MHRA’s Chief Safety Officer, stressed that abruptly stopping antipsychotic medication can cause serious withdrawal symptoms or lead to a rapid relapse of mental illness, which can be dangerous.
She explained that patients should instead remain vigilant for signs of overdose, including extreme drowsiness, vomiting, dizziness, confusion, or slow and shallow breathing. Anyone experiencing these symptoms is advised to seek immediate medical help or attend the nearest accident and emergency department.
Pharmacists and healthcare professionals have been instructed to urgently identify and contact all affected patients and arrange clinical reviews. GPs and specialist teams will assess whether patients need to be switched to alternative treatments and may also review individuals who previously received the affected batches.
The MHRA is also encouraging patients and carers to report any suspected side effects through the Yellow Card scheme, which plays a vital role in monitoring medicine safety across the UK.
For many families within diaspora communities, where mental health stigma can still prevent early intervention, the recall highlights the importance of staying informed and engaged with healthcare providers. Regulators emphasise that systems are in place to protect patients, but clear communication and prompt action remain essential to avoid harm.
Further details, including batch information and recall guidance, are available through the National Patient Safety Alert issued to healthcare services.