All batches\u00a0of\u00a0quetiapine oral\u00a0suspension\u00a0manufactured by Eaststone Limited are being recalled due to a manufacturing error that has resulted in the product\u00a0containing\u00a0twice the amount of active ingredient (quetiapine fumarate) than it should, which could potentially result in\u00a0an\u00a0overdose.\u00a0<\/p>\n
Quetiapine oral suspension\u00a0is supplied as an unlicensed\u00a0\u2018special\u2019\u00a0medicine\u00a0for the management of psychiatric conditions including schizophrenia, bipolar disorder, and as an add-on treatment for depression, where licensed options are not suitable for the patient.\u00a0<\/p>\n
The manufacturer has\u00a0advised\u00a0the Medicines and Healthcare products Regulatory Agency (MHRA) that it is has full traceability of healthcare customers they have supplied directly and has already initiated communications and recall action.<\/p>\n
A total\u00a0of\u00a0166\u00a0bottles\u00a0of the affected product\u00a0were\u00a0manufactured between\u00a026 October 2025 and 26 January 2026.\u00a0<\/p>\n
Patients taking this medicine should check to see if they have any of the batches at home and if they\u00a0haven\u2019t\u00a0yet been contacted,\u00a0they\u2019re\u00a0advised to speak\u00a0to a healthcare professional responsible for their care. The batch number and expiry date can be found on the bottle and\/or dispensing label. Those unsure or unable to\u00a0locate\u00a0the batch number and expiry date, should contact their pharmacist for further advice.\u00a0<\/p>\n
Dr Alison Cave, MHRA Chief Safety Officer, said:\u00a0<\/p>\n
\u201cIt is important that patients do not stop taking their medication until they have spoken to their doctor. Suddenly stopping antipsychotic medication carries risks of severe side effects, including acute withdrawal syndromes or rapid relapse.\u00a0<\/p>\n
\u201cPatients\u00a0should\u00a0be aware of the symptoms of overdose, which include extreme drowsiness, vomiting, dizziness or confusion, and slow or shallow breathing. If you experience any of these symptoms, please seek immediate medical\u00a0assistance\u00a0or visit your nearest accident and emergency centre.\u00a0<\/p>\n
\u201cAnyone who has questions about their medication should\u00a0speak to their healthcare professional. We also encourage patients to report any suspected adverse reactions via the\u00a0MHRA Yellow Card scheme<\/a>.\u201d\u00a0<\/p>\n Pharmacy and other healthcare professionals involved in dispensing these products are advised to\u00a0identify\u00a0and\u00a0immediately\u00a0contact all affected patients to confirm if they have\u00a0any remaining medicine. GPs and specialist clinicians will need to review these patients as soon as possible and consider ongoing treatment options, including switching to alternatives.\u00a0Patients who have taken the affected batches previously may also be contacted for a review.\u00a0<\/p>\n Further information is available in the\u00a0National Patient Safety Alert<\/a>.\u00a0<\/p>\n Notes to editors\u202f\u00a0<\/p>\n For further information about affected products, including batch numbers\u00a0and how to\u00a0locate\u00a0these, please\u00a0refer to the\u00a0National Patient Safety Alert<\/a>.<\/p>\n \u2018Specials\u2019 are products which have been specially manufactured or imported for the treatment of an individual patient. For more information, visit:\u00a0Supply unlicensed medicinal products (specials) – GOV.UK<\/a>\u00a0\u00a0<\/p>\n The Medicines and Healthcare products Regulatory Agency (MHRA)\u00a0is responsible for\u00a0regulating all medicines and medical devices in the UK by ensuring they work\u00a0and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.\u202f\u00a0<\/p>\n The MHRA is an executive agency of the Department of Health and Social Care.\u202f\u00a0<\/p>\n