Quetiapine Oral Suspension Recall NatPSA/2026/002: Class 1 Overdose Risk

What Has Been Recalled and Why

Eaststone Limited, a UK-based specials manufacturer, has issued a Class 1 recall of all batches of its quetiapine oral suspension product. The recall is issued as a National Patient Safety Alert under reference NatPSA/2026/002/MHRA, the most serious category of MHRA medicine recall action.

The recall has been initiated due to a potential risk of overdose. The MHRA has confirmed that the risk to patients is serious enough to warrant a Class 1 designation, meaning there is a reasonable probability that use of the product could cause serious adverse health consequences. Quetiapine is an atypical antipsychotic used in schizophrenia, bipolar disorder, and as augmentation therapy in treatment-resistant depression. Overdose of quetiapine can cause profound sedation, respiratory depression, hypotension, cardiac arrhythmias, and in serious cases can be life-threatening.

The oral suspension formulation is typically used for patients who cannot swallow tablets, including elderly patients, those with swallowing difficulties, and paediatric cases where an oral liquid is clinically required. These are often the most vulnerable patient populations, making the overdose risk particularly significant.

What a Class 1 Recall Means

A Class 1 medicines recall is the most urgent recall category issued by the MHRA. It is reserved for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death. The National Patient Safety Alert designation adds further weight, requiring NHS trusts and healthcare organisations to take immediate action and report completion through their governance frameworks.

For pharmacy and procurement teams, a Class 1 recall of an unlicensed specials product means all stock from that manufacturer must be quarantined immediately, use must cease, and alternative supply must be sourced urgently for any patient currently prescribed the product. Unlike a Class 3 or Class 4 action, there is no acceptable delay in responding to a Class 1 recall.

The fact that this is an unlicensed product, manufactured as a special, adds a layer of complexity. Unlicensed specials are typically prescribed for individual patients who cannot use a commercially available licensed alternative. When a recall affects all batches from a manufacturer of such a product, the entire patient population receiving that product is affected simultaneously.

Who Is Affected

Any hospital pharmacy, community pharmacy, care home, or other healthcare setting holding quetiapine oral suspension manufactured by Eaststone Limited is affected by this recall. Because the recall covers all batches and not just specific lots, stock dating checks do not narrow down the affected population. Every unit from Eaststone Limited must be treated as recalled.

Patients currently prescribed quetiapine oral suspension who are receiving the Eaststone Limited product need their prescribers to be notified immediately. Antipsychotic medications must not be abruptly discontinued. The clinical team will need to identify an alternative source of quetiapine oral suspension or consider whether a dose-appropriate tablet formulation is clinically feasible for the individual patient.

Immediate Steps for Pharmacy and Procurement Teams

1. Quarantine all Eaststone Limited quetiapine oral suspension stock immediately. Remove from active dispensing stock. Label clearly as recalled and segregate to prevent accidental use.
2. Identify all patients currently receiving this product. Check dispensing and prescription records. Every patient currently receiving Eaststone Limited quetiapine oral suspension needs their clinical team notified without delay.
3. Notify prescribers immediately. Psychiatrists, GPs, and any other prescribers with patients on this product must be alerted so they can arrange alternative supply or manage the clinical situation appropriately.
4. Do not allow abrupt discontinuation. Antipsychotic discontinuation carries its own clinical risks including rebound psychosis and withdrawal effects. Prescribers must manage any transition to an alternative.
5. Source alternative quetiapine oral suspension urgently. Other licensed specials manufacturers may hold stock. An MHRA-licensed wholesale dealer can help identify and source an alternative.
6. Follow Eaststone Limited's return instructions for quarantined stock and document all actions taken as part of your trust's or organisation's NatPSA response protocol.

Sourcing Alternative Quetiapine Oral Suspension

Quetiapine oral suspension is not a licensed product in the UK market. It is manufactured by several MHRA-licensed specials manufacturers under the specials manufacturing licence framework. The recall of Eaststone Limited's product does not affect quetiapine oral suspension produced by other licensed manufacturers, meaning alternative supply is potentially available.

An MHRA-licensed wholesale dealer holding a Wholesale Dealer Authorisation (WDA) can assist in identifying and sourcing quetiapine oral suspension from an alternative specials manufacturer. The unlicensed medicines supply chain for specials operates under Regulation 167 of the Human Medicines Regulations 2012, which permits the supply of unlicensed medicines to meet specific patient needs where no licensed alternative is suitable.

Euro Biom is an MHRA WDA-licensed pharmaceutical wholesale exporter experienced in urgent and shortage supply. We work with pharmaceutical procurement teams, hospital pharmacy departments, and healthcare procurement organisations to source specials and unlicensed medicines where standard supply chains have been disrupted. Contact us with your patient requirement and we will work to identify available stock as quickly as possible.