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National Patient Safety Alert: Recall of unlicensed medicine quetiapine oral suspension

NCL Wide

Eaststone Limited have informed the Medicines & Healthcare products Regulatory Agency that batches of unlicensed quetiapine oral suspension contain twice the amount of active agent, which could lead to overdosing. 

Eaststone Limited have confirmed 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. 

Supply can be traced to all healthcare customers who have been supplied with the affected batches. Eaststone Limited have initiated direct communication and recall action with all healthcare customers.

Community Pharmacy and others involved in dispensing will identify and contact patients and inform their GP or any other healthcare professional responsible for the care of the patient, that they may have taken twice the intended dose due to a manufacturing error. 

Actions for prescribers

  • Primary care prescribers should review any patients who have taken either expired or non-expired batches as soon as possible, advising those affected not to stop any treatments without consulting their specialist team for a further review as soon as possible. 
  • As this is a specialist product, patients may require plasma level monitoring and a ECG. Specialist teams may need to be involved in the review, to consider alternative treatment options, where appropriate.

This National Patient Safety Alert NatPSA/2026/002/MHRA, provides further background, clinical information and actions for providers.

Actions to be completed by Thursday 5 February 2026.

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

https://www.gov.uk
Expiry date: Friday, 03 April 2026