An urgent medicines recall has been issued across the United Kingdom after a packaging error led to the wrong antidepressant being placed inside sealed cartons. The alert follows a patient report that uncovered the issue in a commonly prescribed treatment.
More than 80,000 packs are affected, prompting action from the Medicines and Healthcare products Regulatory Agency (MHRA), which has instructed pharmacies and patients to check specific batch details. The recall centres on a mix-up between two widely used selective serotonin reuptake inhibitors (SSRIs).
Packaging Error Identified after Patient Complaint
The recall concerns a single batch of sertraline 100mg film-coated tablets, identified as batch number V2500425. According to the MHRA, one patient discovered that their sealed pack contained a blister strip of citalopram 40mg tablets instead of the prescribed medication. This finding led to a wider investigation and subsequent recall.
The affected batch, consisting of 81,872 packs, was first distributed on 28 November 2025. According to official guidance, the error appears to have occurred during the secondary packaging stage, where blister strips are placed into cartons. Both sertraline and citalopram were manufactured at the same site by Amarox Limited, increasing the likelihood of such a mix-up.
Healthcare professionals have been instructed to stop supplying the affected batch immediately and return any remaining stock. According to the MHRA’s recall notice, pharmacists are also expected to identify and contact patients who may have received the impacted medication, prioritising those who were dispensed the drug recently.
The issue is classified as a Class 2 recall, indicating a defect that could cause temporary or medically reversible adverse health consequences. One reported case involved a patient experiencing a headache, which resolved after discontinuing the medication, according to regulatory documents.
Guidance Issued to Patients and Healthcare Providers
Patients who have been prescribed sertraline are advised to check the batch number printed on the outer packaging and confirm that the blister strips inside match the label. According to the MHRA, no further action is required if the contents are correct. If citalopram tablets are found instead, patients should contact their pharmacy without delay.
Medical advice is recommended for anyone who believes they may have taken the wrong medication or is experiencing side effects. According to statements from MHRA Chief Safety Officer Dr Alison Cave, individuals exposed to citalopram unintentionally may experience serotonergic effects such as nausea, headaches, sleep disturbances, or mild anxiety.
Both medications belong to the SSRI class and are commonly prescribed for depression and anxiety disorders. Despite their similar therapeutic use, unintended substitution can lead to complications, particularly in certain groups. According to the recall notice, higher-risk patients include those over 65, individuals with cardiac or liver conditions, and those taking other medications that affect serotonin levels or heart rhythm.
Healthcare providers may need to monitor affected patients and review treatment plans where necessary. According to regulatory guidance, pharmacists should also coordinate with prescribing clinicians to determine whether a new prescription is required. The MHRA has encouraged reporting of any suspected adverse reactions through the Yellow Card scheme, as part of ongoing safety monitoring.
