The sertraline recall is now under way after the Medicines and Healthcare products Regulatory Agency told healthcare professionals to stop supplying one affected batch and return remaining stock. Amarox Limited is withdrawing batch number V2500425 of Sertraline 100mg film-coated tablets after a manufacturing error led to the wrong antidepressant being placed inside some sealed cartons. The issue was identified after a patient complaint found a blister strip of Citalopram 40mg tablets inside the package.
What the sertraline recall covers
The action affects one batch of Sertraline 100mg film-coated tablets and is being treated as a precautionary measure. The sertraline recall was triggered after the packaging error was traced to the secondary packaging stage, where blister strips were placed into outer cartons.
Both Sertraline and Citalopram are selective serotonin reuptake inhibitors, or SSRIs, used to treat depression, anxiety disorders, and related mental health conditions by boosting serotonin in the brain. The two medicines are made by the same manufacturer at the same site, which is why the mix-up took place within the same production chain.
What patients and pharmacies should do
Dr Alison Cave, Chief Safety Officer at the MHRA, said patients who have been prescribed Sertraline 100mg and received batch number V2500425 should check the carton carefully and look at the batch number and expiry date on the side of the outer packaging. If the blister strips inside the carton are labelled Citalopram 40mg, she said patients should contact their pharmacy as soon as possible. If they are labelled Sertraline 100mg, no further action is needed.
Patients who believe they may already have taken Citalopram 40mg by mistake, or who are experiencing side effects, are being advised to seek medical advice immediately. Dr Cave said people who have accidentally taken citalopram instead of, or as well as, sertraline may experience heightened serotonergic side effects, including nausea, headache, sleep changes, and mild anxiety.
Immediate response from the regulator
Healthcare professionals have been directed to stop supplying the affected batch at once and return all remaining stock to their suppliers. Pharmacists and other dispensing staff are also being asked to identify patients who may have received the compromised product and request its return if any medication remains.
The MHRA classed the case as a Class 2 recall, signaling the need for swift action to reduce risk while the batch is removed from circulation. The sertraline recall remains narrowly focused on the single affected batch, but the instructions are direct: check the pack, verify the label, and act quickly if the contents do not match the prescription.
Why this sertraline recall matters
This case involves a common antidepressant and a packaging error that could expose patients to the wrong medicine without warning. The sertraline recall highlights how a problem at the packaging stage can move quickly from a manufacturing fault to a patient safety issue.
For now, the key step is simple: anyone holding batch V2500425 should inspect the carton immediately. If the contents and labels do not match, the sertraline recall instructions say to contact the pharmacy without delay.
