Batch BeaconUK recalls and safety alerts

Medicines defect noticeMHRA

Risperidone 1mg, 2mg, 3mg Tablets defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Risperidone 1mg, 2mg and 3mg and Tablets.

Check your product

Only products that match these details are covered. Have your pack in front of you.

18 identifiers listed for this notice.

  • Product 1 20

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • NK4910
    Product licenceThe PL number on the carton.
    • PL 04416/0662
    • PL 04416/0663
    • PL 04416/0664
    ExpiryOn the carton, blister or label.
    • Jul-2026
    First distributedOn the product, its label or its packaging.
    • 12-Feb-2024

  • Product 2 60

    Batch code
    • NK4909
    • NL4679
    • MM5115
    • NE5508
    Expiry
    • Aug-2026
    • Oct-2026
    • Jul-2025
    • Mar-2026
    First distributed
    • 17-Jan-2024
    • 12-Jan-2024
    • 03-Mar-2024
    • 09-Aug-2024

What to do now

A printing or labelling mistake affects some packs of Risperidone 1mg, 2mg, 3mg Tablets.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the 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

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(24)A/43). Quoted as issued.

Summary

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Risperidone 1mg, 2mg and 3mg and Tablets.

The risk

DMRC reference number DMRC 32698072 Company name

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 content of this notification, as it provides information that is missing from the current label and take this into account when prescribing. If the medicines listed in this notification are supplied or dispensed, ensure that patients are aware of the missing information displayed above. It is important to advise patients that if patients experience any of the above symptoms they should seek immediate medical advice.

Refer to updated SmPC as follows:

SmPC, Risperidone 1mg Tablets, PL 04416/0662

SmPC, Risperidone 2mg Tablets, PL 04416/0663

SmPC, Risperidone 3mg Tablets, PL 04416/0664

Sandoz Ltd. has confirmed that all future batches will contain the correct PIL. Upon request, Sandoz Ltd. will post hard copies of the updated PIL to pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information (see contact details below).

Patients do not need to take any action. The information above is missing from the Patient Information Leaflet. The missing information, summarised in this notification, does not change or affect the quality of the product. Therefore you can safely continue your treatment. However, should you experience any adverse effects/side effects with the prescribed medication please contact your healthcare professional.

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 do not need to take any action. The information above is missing from the Patient Information Leaflet. The missing information, summarised in this notification, does not change or affect the quality of the product. Therefore you can safely continue your treatment. However, should you experience any adverse effects/side effects with the prescribed medication please contact your healthcare professional.

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 Risperidone 1mg, 2mg, 3mg Tablets been recalled?

A printing or labelling mistake affects some packs of Risperidone 1mg, 2mg, 3mg 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, product licence, 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?

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.

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.

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