Precautionary Recall of Sertraline 100mg Batch V2500425 Due to Packaging Error
Summary
Amarox Limited is recalling one batch of Sertraline 100mg film-coated tablets (batch V2500425) as a precautionary measure after a patient complaint identified that packs contained Citalopram 40mg blister strips instead. Both SSRIs are produced at the same site; the error occurred during secondary packaging. Healthcare professionals are advised to stop supplying the affected batch, contact any patients dispensed the product, and report suspected adverse reactions via the MHRA Yellow Card scheme. Patients who believe they have taken the wrong medication are advised to seek medical advice immediately.
“Amarox Limited is recalling one batch of Sertraline 100mg film-coated tablets as a precautionary measure due to a manufacturing error that led to two antidepressant medicines being packaged incorrectly.”
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
Amarox Limited has issued a precautionary Class 2 recall for one batch of Sertraline 100mg film-coated tablets (V2500425) after a manufacturing error caused Citalopram 40mg blister strips to be packaged inside some Sertraline cartons. The error was identified following a patient complaint. Both drugs are SSRIs used for depression and anxiety.
Pharmacists and healthcare professionals must immediately stop supplying the affected batch, return remaining stock to suppliers, contact any patients who received the product to arrange returns, and notify the patient's GP or clinician for treatment review. Patients who may have taken Citalopram instead of or alongside Sertraline may experience heightened serotonergic side effects and should seek medical advice immediately.
What to do next
- Stop supplying the affected batch of Sertraline 100mg and return all remaining stock to suppliers.
- Identify and contact any patients who may have been dispensed the impacted product and request it be returned.
- Contact the patients' GP or clinician responsible for the care of the patient to discuss treatment review.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Press release
Precautionary recall of antidepressant medication due to manufacturing error
The MHRA has advised healthcare professionals to stop supplying the affected batch of Sertraline 100mg and return all remaining stock to their suppliers.
From: Medicines and Healthcare products Regulatory Agency Published 28 April 2026
Amarox Limited is recalling one batch of Sertraline 100mg film-coated tablets as a precautionary measure due to a manufacturing error that led to two antidepressant medicines being packaged incorrectly.
The recall follows a patient complaint which helped identify that a pack of Sertraline 100mg film-coated tablets contained one blister strip of Citalopram 40mg film-coated tablets inside the sealed carton.
Sertraline and citalopram are both selective serotonin reuptake inhibitors (SSRIs) used to treat depression, anxiety disorders, and related mental health conditions by boosting brain serotonin.
Both SSRI medications are produced by the same manufacturer, at the same site, and the error appears to have occurred during secondary packaging of the blister strips into the cartons.
Patients who believe they have already taken any Citalopram 40mg tablets by mistake or are experiencing side effects, are advised to seek medical advice immediately.
Dr Alison Cave, MHRA Chief Safety Officer, said:
“If you have been prescribed Sertraline 100mg tablets and have received batch number V2500425, please check the carton contains the right medication. You can find the batch number and expiry date printed on the side of the outer packaging.
“If the blister strips inside the carton are labelled Citalopram 40mg, please contact your pharmacy as soon as possible. If they are labelled Sertraline 100mg, no further action is needed.”
“Patients who have accidentally taken citalopram instead of - or as well as - sertraline, may experience some heightened serotonergic side effects. These can include nausea, headache, sleep changes, and mild anxiety.”
Pharmacists, or any other healthcare professionals involved in dispensing should identify and contact any patients who may have been dispensed the impacted product and request it be returned if they have any remaining medicine.
If any patients are identified with this product, pharmacists and other healthcare professionals involved in dispensing should contact the patients’ GP, or clinician responsible for the care of the patient, to discuss treatment review and whether a new prescription is required for ongoing resupply.
Patients may need to be monitored by their doctor or another healthcare professional, particularly if they are over 65 or under 18, have cardiac or liver conditions, or have been told that their body processes certain medicines differently.
Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
The MHRA has advised healthcare professionals to stop supplying the affected batch and return all remaining stock to their suppliers.
Notes to editors
- Please see MHRA’s Class 2 recall for further information and images of the affected product.
- The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
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Published 28 April 2026
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