Sertraline Recall Issued After Packaging Error Sees Wrong Antidepressant Sealed in Packs

A safety recall has been issued for a batch of the antidepressant sertraline after a packaging error led to a different medication being placed inside sealed cartons, UK regulators have said.

The Medicines and Healthcare products Regulatory Agency (MHRA) confirmed on 28 April 2026 that one batch of sertraline 100mg tablets is being recalled after a patient reported finding a blister strip of citalopram 40mg inside the packaging. The issue has prompted guidance to healthcare providers to stop supplying the affected batch and return remaining stock.

The alert relates to batch number V2500425. Patients who have received the medication are being advised to check their packaging and contact a pharmacist if they have concerns. The MHRA said the recall is precautionary and no wider manufacturing fault has been identified.

Packaging Error Identified After Patient Report

According to the MHRA, both sertraline and citalopram are selective serotonin reuptake inhibitors (SSRIs) used to treat depression and anxiety. The medicines are produced at the same site, and the error is believed to have occurred during the final stage of packaging, when blister strips were placed into cartons.

Dr Alison Cave, the MHRA's Chief Safety Officer, said patients prescribed sertraline 100mg should check that the blister strips inside the box match the label on the outer packaging.

'If the blister strips inside the carton are labelled citalopram 40mg, please contact your pharmacy as soon as possible,' she said. 'If they are labelled sertraline 100mg, no further action is needed.'

Guidance for Patients and Healthcare Providers

Patients who believe they may have taken citalopram instead of sertraline are advised to seek medical advice, particularly if they experience side effects. These may include nausea, headaches, changes in sleep patterns or mild anxiety.

The MHRA said pharmacists and other healthcare professionals should identify and contact anyone who may have received the affected batch. Remaining medication should be returned, and a review of treatment may be required to ensure continuity of care.

Additional monitoring may be needed for some patients, including those over 65, under 18, or with existing heart or liver conditions. Healthcare professionals have also been asked to report any suspected adverse reactions through the Yellow Card scheme.

Recall Measures and Safety Oversight

The recall has been classified as a Class 2 alert, meaning action is required within 48 hours. The MHRA has instructed suppliers and pharmacies to remove the affected batch from circulation and return it.

The agency said the issue appears to have occurred during the final packaging stage, with no evidence of a fault in how the medicines were made. Both medications involved are widely prescribed and approved for use in the UK.

The MHRA regulates medicines and medical devices to ensure they meet safety and quality standards. It said the recall was issued as a precaution while investigations continue.

Ongoing Investigation

The MHRA said it is working with the manufacturer, Amarox Limited, to determine how the error occurred and to prevent similar incidents in future.

Patients are advised to check their medication carefully and contact a pharmacist or GP if they are unsure about their prescription. Further updates will be provided as the investigation progresses.