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Medicines defect noticeMHRA

Concerta XL 18mg & 36 mg prolonged release tablets defect notice over a packaging defect

Packaging or device defectLow riskClass 4

Orifarm UK has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged within the parallel import packs of the specific batches of Concerta XL 18mg and 36mg prolonged release tablets mentioned in this notification.

Check your product

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

38 identifiers listed for this notice.

  • Concerta XL 18mg & 36 mg prolonged release tablets 30 tablets

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 3EE35801
    • 3EE35802
    • 3EE36101
    • 3EE35803
    • 3EE36102
    • 3FE46100
    • 3FE46101
    • 3GE51900
    • 3AE07102
    • 3DE29500
    • 3FE44101
    • 3FE44102
    • 3AE07103
    • 3DE29201
    • 3DE29501
    • 3FE44103
    • 3FE46800
    • 3FE46801
    • 3EE37002
    • 3GE50002
    ExpiryOn the carton, blister or label.
    • 31/01/2026
    • 31/12/2025
    • 28/02/2026
    • 30/09/2025
    • 31/03/2026
    First distributedOn the product, its label or its packaging.
    • 03/11/2023
    • 09/11/2023
    • 06/12/2023
    • 14/12/2023
    • 02/01/2024
    • 08/01/2024
    • 24/01/2024
    • 06/11/2023
    • 23/11/2023
    • 07/12/2023
    • 18/12/2023
    • 11/01/2024
    • 17/01/2024

What to do now

Some packs of Concerta XL 18mg & 36 mg prolonged release tablets have a defect that could affect how the medicine is given.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. Report suspected side effects to the MHRA Yellow Card scheme.

Why it matters. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

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/07). Quoted as issued.

Summary

Orifarm UK has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged within the parallel import packs of the specific batches of Concerta XL 18mg and 36mg prolonged release tablets mentioned in this notification.

The risk

MDR number MDR 060-02/24 Company name

Advice for healthcare professionals

Healthcare professionals are advised to inform patients of this discrepancy when dispensing packs from the specified batches.

Patients do not need to take any action. This issue is about an error in the patient information leaflet that accompanies the above specified batches of Concerta XL18mg and 36mg prolonged release tablets. Some information on the side effects is incorrectly included in paragraph 3 instead of paragraph 4. The quality of the medicine is not affected.

Patients who experience adverse reactions or have any questions about the 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. This issue is about an error in the patient information leaflet that accompanies the above specified batches of Concerta XL18mg and 36mg prolonged release tablets. Some information on the side effects is incorrectly included in paragraph 3 instead of paragraph 4. The quality of the medicine is not affected.

Patients who experience adverse reactions or have any questions about the 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 Concerta XL 18mg & 36 mg prolonged release tablets been recalled?

Some packs of Concerta XL 18mg & 36 mg prolonged release tablets have a defect that could affect how the medicine is given. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

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.

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