An urgent safety alert has been issued for patients taking the antipsychotic medication quetiapine, following the recall of all batches of an oral suspension due to a critical manufacturing error. The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that the product contains twice the intended amount of active ingredient, significantly increasing the risk of overdose.
Immediate Recall of Affected Batches
The recall affects all batches of quetiapine oral suspension manufactured by Eaststone Limited between 26 October 2025 and 26 January 2026. A total of 166 bottles have been identified as containing double the prescribed amount of quetiapine fumarate. This unlicensed 'special' medicine is typically prescribed for managing psychiatric conditions including schizophrenia, bipolar disorder, and as an add-on treatment for depression when licensed alternatives are unsuitable.
Manufacturer's Response and Patient Action
The manufacturer has confirmed full traceability of healthcare customers supplied directly and has initiated communication and recall procedures. Patients currently taking this medication are urged to check their bottles immediately for batch numbers and expiry dates.
Critical patient guidance includes:
- Do not stop taking medication without consulting your doctor first
- Check if you have any of the affected batches at home
- Contact your healthcare professional if you haven't been notified
- Seek immediate medical assistance if experiencing overdose symptoms
Recognising Overdose Symptoms
Dr Alison Cave, MHRA Chief Safety Officer, has emphasised the importance of recognising potential overdose symptoms, which include:
- Extreme drowsiness and dizziness
- Vomiting and confusion
- Slow or shallow breathing patterns
Patients experiencing any of these symptoms should seek immediate medical attention or visit their nearest accident and emergency centre without delay.
Healthcare Professional Responsibilities
Pharmacy staff and healthcare professionals involved in dispensing these products have been instructed to identify and contact all affected patients immediately. General practitioners and specialist clinicians must review these patients as soon as possible to consider alternative treatment options, including switching to appropriate alternatives.
The MHRA has also confirmed that patients who have previously taken affected batches may be contacted for medical review to ensure their ongoing safety and wellbeing.
Reporting and Further Information
Patients and healthcare professionals are encouraged to report any suspected adverse reactions through the MHRA Yellow Card scheme. Comprehensive information about this critical safety alert is available in the National Patient Safety Alert, which provides detailed guidance for both patients and medical practitioners.
This developing situation requires immediate attention from all parties involved in the prescription, dispensing and consumption of quetiapine oral suspension to prevent potential harm to vulnerable patients.
