Medicines recallMHRA
Sertraline 100mg film-coated tablets recalled over a quality concern
Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site.
Check your product
Only products that match these details are covered. Have your pack in front of you.
3 identifiers listed for this notice.
Sertraline 100mg film-coated tablets 28
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- V2500425
- ExpiryOn the carton, blister or label.
- 05/2028
- First distributedOn the product, its label or its packaging.
- 28 November 2025
What to do now
A quality problem has been identified with Sertraline 100mg film-coated tablets.
- Keep taking your medicine unless a healthcare professional tells you otherwise.
- Check the batch number and expiry date on your pack against the list on this page.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.
An affected pack bought over the counter can be returned to where you bought it.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/22). Quoted as issued.
Summary
Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site.
The risk
DMRC reference number DMRC - 39135670 Marketing Authorisation Holder
Advice for healthcare professionals
Stop supplying the affected batch of Sertraline 100 mg film-coated tablets (Batch Number V2500425) immediately. Quarantine all remaining stock and return it to your supplier using your approved returns process.
If batch/product traceability information is available, pharmacy professionals and other healthcare professionals involved in dispensing should identify and immediately contact all patients who have been dispensed the impacted product and ask them to confirm if they have remaining stock within their possession for return.
If batch/product traceability information is not available, pharmacists should identify all patients dispensed this product from 28 November 2025 onwards. Where appropriate and feasible, contact all patients who have been dispensed the impacted product with priority given to those who have been dispensed the product most recently and within the last 28 days. The majority of this was distributed in 2025 and therefore it is expected that many of these packs will have been dispensed to patients and consumed.
If any patients are identified with this product, pharmacy professionals and other healthcare professionals involved in dispensing should contact the patients’ GP, or healthcare professional responsible for the care of the patient, to discuss treatment review and whether a new prescription is required for ongoing resupply.
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. Healthcare professionals should be advised to inform patients who may have inadvertently ingested citalopram tablets in place of or in addition to their prescribed sertraline, that they may experience increased serotonergic effects.
The reported adverse event in this case was a headache, which resolved on discontinuation; however, in susceptible individuals’ concurrent exposure to two SSRIs may carry a risk of more pronounced serotonergic effects. The risk is however higher in patients with pre-existing cardiac conditions, those aged over 65 years, or those taking concomitant serotonergic or QT prolonging medication.
Additionally, as some patients may require monitoring, including patients over 65 years old or under 18 years old, those with hepatic impairment and individuals who are known to be, or predicted to be a poor metaboliser for CYP2C19 substrates and therefore other clinicians and healthcare professionals may need to be involved. Healthcare professionals should be aware that only the batch stated in this notification is impacted.
Some cartons of Sertraline 100 mg film-coated tablets, manufactured by Amarox Limited, may contain a blister strip(s) of Citalopram 40 mg tablets. All packs of Sertraline 100 mg film-coated tablets, Batch Number V2500425, are being recalled as a precautionary measure.
If you have been prescribed Sertraline 100 mg film-coated tablets and have received impacted product (Batch Number V2500425), please check that the carton contains the correct medication. The batch number and expiry date can be found printed on the side of the outer carton.
If the carton contains blister strips that are labelled and contain Citalopram 40 mg film-coated tablets, contact your dispensing pharmacy in the first instance.
If the carton contains blister strips that are labelled and contain Sertraline 100 mg film-coated tablets, you do not need to take further action.
If you have an impacted pack or previously received this batch, (where known) and you believe you have taken the Citalopram 40 mg film-coated tablets that were included in error and are currently experiencing any side effects, then please seek immediate medical advice.
Advice for patients
Some cartons of Sertraline 100 mg film-coated tablets, manufactured by Amarox Limited, may contain a blister strip(s) of Citalopram 40 mg tablets. All packs of Sertraline 100 mg film-coated tablets, Batch Number V2500425, are being recalled as a precautionary measure.
If you have been prescribed Sertraline 100 mg film-coated tablets and have received impacted product (Batch Number V2500425), please check that the carton contains the correct medication. The batch number and expiry date can be found printed on the side of the outer carton.
If the carton contains blister strips that are labelled and contain Citalopram 40 mg film-coated tablets, contact your dispensing pharmacy in the first instance.
If the carton contains blister strips that are labelled and contain Sertraline 100 mg film-coated tablets, you do not need to take further action.
If you have an impacted pack or previously received this batch, (where known) and you believe you have taken the Citalopram 40 mg film-coated tablets that were included in error and are currently experiencing any side effects, then please seek immediate medical advice.
Please take the leaflet that came with your medicine and any remaining tablets with you to your pharmacy or GP practice. If you are unsure or have any questions, please seek advice from your pharmacy or other healthcare professionals responsible for your care.
Both sertraline and citalopram are used to treat depression and anxiety; however, as your body may not be accustomed to citalopram, you may experience most common possible side effects such as nausea, headache, sleep changes and mild anxiety.
The description of the tablets from the Patient Information Leaflets (PILs) are as follows:
Sertraline 100 mg film-coated tablets: White to off white, film-coated, capsule shaped biconvex tablets and debossed with ‘3 and 1’ on either side of score line on one side and “HS” on other side. Click here for PIL
Citalopram 40 mg film-coated tablets: White to off-white coloured, film coated, oval biconvex tablets, debossed with “Z and 9” on either side of the score line and “H” on the other side. Click here for PIL
See below images showing the different medicines and where to find the batch number of the product and the identification of the incorrect blister strip.
Sertraline 100 mg film-coated tablets - Batch Number V2500425, Outer carton and Lot (Batch Number) /EXP Date information.
Open the MHRA notice
Questions
Why has Sertraline 100mg film-coated tablets been recalled?
A quality problem has been identified with Sertraline 100mg film-coated tablets. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.
How do I know if my medicine is affected?
Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.
Do I need a new prescription?
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.