Quetiapine Oral Suspension Recalled Over Manufacturing Error
All batches of quetiapine oral suspension produced by Eaststone Limited are being withdrawn from circulation due to a serious manufacturing error. The medication has been found to contain double the recommended dosage of its active ingredient, quetiapine fumarate, which raises concerns over potential overdose risks for patients.
Details of the Recall
The recall pertains specifically to an unlicensed ‘special’ medicine used to treat a range of psychiatric disorders, including schizophrenia and bipolar disorder, and as an adjunct for depression when licensed treatments are unsuitable. Eaststone Limited has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that they can fully trace the healthcare customers who received the product and have already commenced the recall process.
A total of 166 bottles of the affected quetiapine suspension were manufactured between 26 October 2025 and 26 January 2026. Patients are urged to verify if they possess any of these batches at home. Those who have not yet received communication regarding the recall should consult with their healthcare provider to discuss their treatment options. Information regarding the batch number and expiry date is available on the product bottle or dispensing label. If patients are unable to locate this information, they are advised to contact their pharmacist for assistance.
Guidance from MHRA Officials
Dr Alison Cave, Chief Safety Officer at the MHRA, stressed the importance of not discontinuing medication without consulting a healthcare professional. She warned that abruptly stopping antipsychotic medications can lead to severe side effects, including acute withdrawal symptoms and potential relapse.
Dr Cave also highlighted the symptoms of overdose, which may include extreme drowsiness, confusion, dizziness, nausea, or slow and shallow breathing. Patients experiencing these symptoms should seek immediate medical attention or head to the nearest accident and emergency department.
Action for Healthcare Professionals
Pharmacy staff and other healthcare professionals are advised to proactively identify and reach out to any affected patients. General practitioners and specialists must review their patients’ medications promptly and consider alternative treatment options. Furthermore, individuals who have previously taken the affected batches may also be contacted for follow-up evaluations.
For further guidance and information, healthcare providers and patients can refer to the National Patient Safety Alert.
Background
Quetiapine is primarily prescribed for managing various psychiatric conditions, and this recall highlights the critical importance of manufacturing quality and oversight in the pharmaceutical industry. The MHRA is responsible for ensuring safe and effective medicines in the UK, and this incident underscores their vigilant role in safeguarding public health.
Source: official statements, news agencies, and public reports.
https://www.gov.uk/government/news/medicines-recall-of-all-quetiapine-oral-suspension-batches-from-eaststone-limited-due-to-incorrect-amount-of-active-ingredient
