MHRA: Quetiapine Oral Suspension Recalled Due to Incorrect Active Ingredient

MHRA Guidance & Safety

Filed January 29th, 2026

Detected February 6th, 2026

Summary

The MHRA has issued a recall for all batches of quetiapine oral suspension manufactured by Eaststone Limited due to an incorrect amount of the active ingredient, potentially leading to overdose. Approximately 166 bottles manufactured between October 2025 and January 2026 are affected. Patients are advised not to stop medication without consulting a healthcare professional.

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What changed

The Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a Class 1 recall for all batches of quetiapine oral suspension manufactured by Eaststone Limited. The recall is due to a manufacturing error where the active ingredient, quetiapine fumarate, is present at twice the intended amount, posing a risk of overdose. A total of 166 bottles manufactured between October 26, 2025, and January 26, 2026, are affected. This action is classified as urgent due to the potential for serious patient harm.

Healthcare providers, including GPs and specialist clinicians, must identify and contact affected patients immediately to review their treatment and consider alternative options. Patients are strongly advised not to discontinue their medication abruptly due to withdrawal risks and should consult their healthcare professional if they have concerns or experience overdose symptoms such as extreme drowsiness, vomiting, dizziness, confusion, or slow breathing. Patients are also encouraged to report suspected adverse reactions via the MHRA Yellow Card scheme. The manufacturer has initiated recall actions and has full traceability of direct healthcare customers.

Source document (simplified)

Press release

Medicines recall of all quetiapine oral suspension batches from Eaststone Limited due to incorrect amount of active ingredient

Batches of quetiapine oral suspension from Eaststone Limited are being recalled due to the active content being twice the amount it should be. Patients should not stop taking this medicine without consulting their healthcare professional.

From: Medicines and Healthcare products Regulatory Agency Published 29 January 2026

All batches of quetiapine oral suspension manufactured by Eaststone Limited are being recalled due to a manufacturing error that has resulted in the product containing twice the amount of active ingredient (quetiapine fumarate) than it should, which could potentially result in an overdose.

Quetiapine oral suspension is supplied as an unlicensed ‘special’ medicine for 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.

The manufacturer has advised the 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.

A total of 166 bottles of the affected product were manufactured between 26 October 2025 and 26 January 2026.

Patients taking this medicine should check to see if they have any of the batches at home and if they haven’t yet been contacted, they’re advised to speak to 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 locate the batch number and expiry date, should contact their pharmacist for further advice.

Dr Alison Cave, MHRA Chief Safety Officer, said:

“It 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.

“Patients should be 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 assistance or visit your nearest accident and emergency centre.

“Anyone who has questions about their medication should speak to their healthcare professional. We also encourage patients to report any suspected adverse reactions via the MHRA Yellow Card scheme.”

Pharmacy and other healthcare professionals involved in dispensing these products are advised to identify and immediately contact all affected patients to confirm if they have any 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. Patients who have taken the affected batches previously may also be contacted for a review.

Further information is available in the National Patient Safety Alert.

Notes to editors

For further information about affected products, including batch numbers and how to locate these, please refer to the National Patient Safety Alert.
‘Specials’ are products which have been specially manufactured or imported for the treatment of an individual patient. For more information, visit: Supply unlicensed medicinal products (specials) - GOV.UK
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.
For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.