What's Happening?
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 1 recall for all batches of quetiapine oral suspension produced by Eaststone Limited. The recall was prompted by a manufacturing error that resulted in the product containing
twice the intended amount of quetiapine fumarate. Quetiapine is an antipsychotic medication used to treat conditions such as schizophrenia and bipolar disorder. The recall affects 166 products distributed between October 2025 and January 2026. Pharmacy teams are instructed to stop supplying the affected products, quarantine remaining stock, and inform patients and healthcare providers of the potential overdose risk.
Why It's Important?
The recall of quetiapine oral suspension is critical for patient safety, as the dosage error could lead to serious health risks, including overdose symptoms such as extreme drowsiness and confusion. The situation underscores the importance of stringent quality control measures in pharmaceutical manufacturing. Healthcare providers must act swiftly to mitigate risks to patients, including monitoring plasma levels and conducting treatment reviews. The recall also highlights the need for effective communication between manufacturers, regulatory agencies, and healthcare professionals to ensure patient safety and maintain trust in the healthcare system.
What's Next?
Pharmacy teams are required to complete the recall process by February 2026, including contacting affected patients and healthcare providers. Patients are advised not to stop their medication abruptly and to seek medical advice if they experience overdose symptoms. The MHRA encourages reporting of adverse reactions through its Yellow Card scheme. The recall may prompt further investigations into manufacturing practices and regulatory compliance to prevent similar incidents in the future. Healthcare professionals will need to ensure that alternative treatments are available to affected patients to avoid disruptions in their care.
