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This alert is for action by: ​primary and secondary care, specifically those involved in pharmacy services, including dispensing general practices and those involved in the prescribingÌýfor mental health conditions.ÌýThis is a safety critical and complex National Patient Safety Alert.

Implementation should be coordinated by an executive leader (or equivalent role in organisations without executive boards) supported by Chief Pharmacists, as well as leaders in general practice and community pharmacy.

National Patient Safety Alert Reference Number

NatPSA/2026/002/MHRA

DMRC reference Number

DMRC- 38317654

Licence Holder

Eaststone Limited

Medicine details

Quetiapine 12.5 mg/5 ml Oral Suspension

Unlicensed medicine: MS 32967

Active Ingredient: quetiapine fumarate

SNOMED code: N/A

GTIN: N/A

FOR AFFECTED LOT/BATCH NUMBERS – SEE ANNEX 1 OF RECALL DOCUMENT

Quetiapine 25 mg/5 ml Oral Suspension

Unlicensed medicine: MS 32967

Active Ingredient: quetiapine fumarate

SNOMED code: N/A

GTIN: N/A

FOR AFFECTED LOT/BATCH NUMBERS – SEE ANNEX 2 OF RECALL DOCUMENT

Quetiapine 50 mg/5 ml Oral Suspension

Unlicensed medicine: MS 32967

Active Ingredient: quetiapine fumarate

SNOMED code: N/A

GTIN: N/A

FOR AFFECTED LOT/BATCH NUMBERS – SEE ANNEX 3 OF RECALL DOCUMENT

Quetiapine 100 mg/5 ml Oral Suspension

Unlicensed medicine: MS 32967

Active Ingredient: quetiapine fumarate

SNOMED code: N/A

GTIN: N/A

FOR AFFECTED LOT/BATCH NUMBERS – SEE ANNEX 4 OF RECALL DOCUMENT

Quetiapine 200 mg/5 ml Oral Suspension

Unlicensed medicine: MS 32967

Active Ingredient: quetiapine fumarate

SNOMED code: N/A

GTIN: N/A

FOR AFFECTED LOT/BATCH NUMBERS – SEE ANNEX 5 OF RECALL DOCUMENT

Explanation of identified safety issue

EaststoneÌýLimited have informed MHRA that the formula they have used to manufacture all batches ofÌýquetiapineÌýoral suspension products is incorrect. The active content is twice the amount that it should be which could lead to overdosing.ÌýÌý

Eaststone Limited have clarified that a total of 166 units/bottles were manufactured between 26 October 2025 and 26 January 2026 and distributed to healthcare customers. The remainder of bottles have been quarantined and will not be supplied. This notification includes batches that have expired. Any patients who have taken batches, including both expired and non-expired should be reviewed. Eaststone Limited have confirmed that they can trace supply to all healthcare customers who have been supplied with the impacted products.

Patients should be advised not to stop any treatments without consulting their relevant healthcare professional and a treatment review should be initiated as soon as possible.

Withdrawal of antipsychotic drugs after long-term therapy should always be gradual and closely monitored to avoid the risk of acute withdrawal syndromes or rapid relapse. Patients should be monitored for 2 years after withdrawal of antipsychotic medication for signs and symptoms of relapse.

Actions required

Actions required to complete by 05 February 2026

The action to recall should be coordinated by the Chief Pharmacist/Superintendent Pharmacist or Responsible Pharmacist and Dispensing GPs in the first instance, with support from other HCPs. Stop supplying the impacted batch immediately. Quarantine all remaining stock and return it to your supplier/MAH using your supplier’s approved process.

1. Stop supplying theÌýEaststoneÌýLimited productÌýimmediately. Quarantine all remaining stock and return it to your supplier using your approved process.Ìý

2. EaststoneÌýLimitedÌýhave full traceability of healthcare customers they have suppliedÌýdirectlyÌýand have alreadyÌýinitiatedÌýcommunication and recall action, therefore most healthcare professionals will be made directly aware via the company.Ìý

3. Pharmacy professionalsÌýand other healthcareÌýprofessionalsÌýinvolved in dispensing medicinal products shouldÌýidentifyÌýandÌýimmediatelyÌýcontact all patients who have been dispensed the impacted products and ask them to confirm if they have remaining stock within their possession. If batch/product traceability information is not available, all patients dispensed this product sinceÌý26 October 2025ÌýtoÌý26 January 2026Ìýshould be contacted.Ìý

4. IfÌýany patients are identified with this product,Ìýpharmacy professionals and other healthcare professionals involved in dispensingÌýshould alsoÌýcontact the patients GP, or healthcare professional responsible for the care of the patient if this information is available (e.g. specialist prescriber or nurse)ÌýandÌýadvise that the patient may have taken twice the intended doseÌýdue to a manufacturing error.ÌýTherefore,ÌýimmediateÌýongoing treatment of the patientÌýneeds to be reviewed. As this is a specialist use product, patients mayÌýrequireÌýplasma levelÌýmonitoringÌýand ECGÌýandÌýother clinicians and healthcare professionals may need to be involvedÌýin the patients reviewÌýand to consider alternative treatment options, whereÌýappropriate.Ìý

5. Healthcare professionals should be awareÌýof andÌýdiscuss the risk ofÌýoverdose which can present asÌýsevereÌýcentral nervous system depressionÌý(sedation, coma, respiratory depression),ÌýconfusionÌýand agitation, seizuresÌýtachycardia, and hypotension with patients and advise themÌýto contact the healthcare professional responsible for their care,Ìýor their community psychiatric nurse,Ìýor carerÌýto seek medical attention ifÌýthese symptoms develop.

Advice for healthcare professionals to provide to patients

A manufacturing error has beenÌýidentifiedÌýfor all batches of quetiapine oral suspension made byÌýEaststoneÌýLimited which means the productÌýcontainsÌýtwice as much quetiapine compared to the amount that was prescribed.Ìý

Your pharmacist or other healthcare professionals should contact you if you have been dispensed the impacted products and ask you to confirm if you still have some medicine within your possession.Ìý

However, it is important that if you are taking quetiapine oral suspension, you should check to see if you have any of the specific batches at home. The batch number and expiry date can be found on the bottle and/or dispensing label. If you are unsure or unable toÌýlocateÌýthe batch number and expiry date, please contact your pharmacist for further advice.ÌýÌý

Patients should be aware of the symptoms of overdoseÌýsuch as extreme drowsiness, vomiting,ÌýdizzinessÌýor confusion, slow or shallow breathing. If they experience any of these symptoms, then they should seek immediate medicalÌýassistanceÌýor visit the nearest accident and emergency centre.ÌýÌý

PatientsÌýareÌýadvised to not stopÌýtaking their medication until they have spoken to their doctor. This is because suddenly stopping your medication also carries risks of severe side effects.ÌýÌý

Your pharmacist, GP/doctor, or other healthcare professional will contact you as soon as possible to consider review of your treatment and to discuss any potential side effects experienced and ongoing monitoring. They will also advise on switching to an alternative treatment. ÌýPatients who have taken the affected batches previously may also be contacted for a review.Ìý

Any patient that may be worried that they have taken an affected batch can contact their healthcare professional to discuss any questions they may have.ÌýÌý

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via theÌý.

Additional information

For more information or stock and, please contactÌýEaststoneÌýLimited on +44(0)800 678 3102 (Select Option 1) or emailÌýspecials@eaststone.co.ukÌý

For medical information queries, please contactÌýEaststoneÌýLimited on +44(0)800 678 3102 (Select Option 3) or emailÌýumar.ahmed@eaststone.co.ukÌý

For all other enquires place contactÌýEaststoneÌýLimited +44(0)800 678 3102 (Select Option 3) or emailÌýumar.ahmed@eaststone.co.ukÌý

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked toÌýforwardÌýthis to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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