Antipsychotic drug recalled in UK after manufacturing error leads to overdosing

THE UK medicines regulator has recalled all batches of a specific formulation of an antipsychotic drug after the manufacturer discovered a production error that resulted in bottles containing double the intended dose.

The Class 1 recall, issued in late January after manufacturer Eaststone discovered they were using an incorrect formula, applied to all batches of quetiapine oral suspension distributed by the company since 26 October 2025. The affected formulations were unlicensed, meaning they had not been subject to safety and efficacy assessments by the Medicines and Healthcare Products Regulatory Agency (MHRA) and were supplied to meet specific patient needs where licensed alternatives were unsuitable.

Eaststone has confirmed that 166 bottles, produced in 72 batches, were distributed. All remaining batches have been quarantined and Eaststone confirmed it has full traceability of the prescribers supplied.

Class 1 recalls are the most serious safety alerts issued by the MHRA and are served where a defect presents a risk of death or disability. The MHRA has not received any patient reports of adverse reactions but has advised patients taking Eaststone-manufactured quetiapine to contact their doctor immediately and to report any suspected incidents via the regulator’s Yellow Card scheme. Symptoms of overdose can include extreme drowsiness, vomiting, dizziness, confusion and slow or shallow breathing.

Quetiapine is prescribed to treat schizophrenia or bipolar disorder and can also supplement antidepressants. It carries serious side effects, including rapid heartbeat and dizziness, while up to 10% of patients experience worsened depression including increased suicidal thoughts. The MHRA’s chief safety officer stressed that patients should not stop taking the medicine without medical advice, warning that sudden withdrawal can cause severe side effects or rapid relapse.

Eaststone declined to comment.

What are unlicensed medicines?

Unlicensed medicines, often known as “specials”, are prescribed when a licensed product does not meet a patient’s specific needs, for example where a liquid formulation is required. While unlicensed products are not subject to the same authorisation process as licensed medicines, their manufacturing sites are inspected by the MHRA.

The only MHRA-licensed quetiapine oral suspension product is a 20 mg/ml formulation manufactured by Rosemount and licensed for adults. Recalled Eaststone products were supplied as of 12.5 mg/5 ml, 25 mg/5 ml, 50 mg/5 ml, 100 mg/5 ml and 200 mg/5 ml suspensions but were found to contain double the active ingredient, quetiapine fumarate.