Medicines defect noticeMHRA
Moclobemide 150mg tablets defect notice over a labelling error
Lexon UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification is missing important updated safety information.
Check your product
Only products that match these details are covered. Have your pack in front of you.
6 identifiers listed for this notice.
Moclobemide 150mg tablets 30
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- I3602
- H4610
- ExpiryOn the carton, blister or label.
- 30/09/2027
- 31/05/2029
- First distributedOn the product, its label or its packaging.
- 11/02/2025
- 23/09/2025
What to do now
There is an error on the label, carton or patient leaflet for Moclobemide 150mg 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. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
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
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.
Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/50). Quoted as issued.
Summary
Lexon UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification is missing important updated safety information.
The risk
DMRC reference number DMRC - 37693641 Marketing Authorisation Holder
Advice for healthcare professionals
There is no risk to product quality or impact to safety of the medicines listed in this notification because of this missing information. Healthcare professionals are advised to review the information contained within this notification and take this into account when dispensing this product, especially for new patients.
If the medicine listed in this notification are dispensed, ensure that patients are aware of the missing information. Please see updated PIL for the correct information.
Upon request, Lexon UK Ltd will provide hard copies of the updated PIL to pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact Lexon UK Ltd with your details, i.e. address, product with batch details, required number of leaflets.
Patients should be aware that packs of Moclobemide 150mg Tablets, Batches I3602 and H4610, contain the incorrect Patient Information Leaflet (PIL). The missing safety information is listed in this notification and if you have any additional concerns relating to this information, please contact your pharmacist or prescriber.
The missing information, summarised in this notification, does not change or affect the quality of the product. Patients can continue to safely take this medicine unless they have concerns related to the missing information.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Advice for patients
Patients should be aware that packs of Moclobemide 150mg Tablets, Batches I3602 and H4610, contain the incorrect Patient Information Leaflet (PIL). The missing safety information is listed in this notification and if you have any additional concerns relating to this information, please contact your pharmacist or prescriber.
The missing information, summarised in this notification, does not change or affect the quality of the product. Patients can continue to safely take this medicine unless they have concerns related to the missing information.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Open the MHRA notice
Questions
Why has Moclobemide 150mg tablets been recalled?
There is an error on the label, carton or patient leaflet for Moclobemide 150mg tablets. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
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?
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.