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Medicines recallMHRA

Napralief 250mg Gastro-Resistant Tablets recalled over a labelling error

Labelling or leaflet errorMedium riskClass 3

Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the Patient Information Leaflet (PIL) and on the Carton in packs of Napralief 250mg Gastro-resistant tablets.

Check your product

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

8 identifiers listed for this notice.

  • Napralief 250mg Gastro-Resistant Tablets 9 Tablets

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • B51496
    • B51497
    • B51102
    ExpiryOn the carton, blister or label.
    • 31/10/2028
    • 31/07/2028
    First distributedOn the product, its label or its packaging.
    • 31/12/2025
    • 03/02/2026
    • 23/12/2025

What to do now

The issue with Napralief 250mg Gastro-Resistant Tablets is information: something on the packaging or leaflet is wrong or missing.

  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

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/21). Quoted as issued.

Summary

Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the Patient Information Leaflet (PIL) and on the Carton in packs of Napralief 250mg Gastro-resistant tablets.

The risk

Post Publication Note This recall, first published on 23 April, has been updated. The Marketing Authorisation Holder has provided a corrected expiry date for one of the affected batches. DMRC reference number

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.

Do not take more than three tablets per day.

Patients should be aware that the Patient Information Leaflet (PIL) and Carton in certain batches of Napralief 250mg Gastro-resistant tablets do not contain the most up to date safety information and should refer to the correct information listed above.

No further action is required by patients. This recall is being undertaken as a precautionary measure and applies at Pharmacy and Wholesaler level.

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

This recall, first published on 23 April, has been updated. The Marketing Authorisation Holder has provided a corrected expiry date for one of the affected batches.

Do not take more than three tablets per day.

Patients should be aware that the Patient Information Leaflet (PIL) and Carton in certain batches of Napralief 250mg Gastro-resistant tablets do not contain the most up to date safety information and should refer to the correct information listed above.

No further action is required by patients. This recall is being undertaken as a precautionary measure and applies at Pharmacy and Wholesaler level.

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 Napralief 250mg Gastro-Resistant Tablets been recalled?

The issue with Napralief 250mg Gastro-Resistant Tablets is information: something on the packaging or leaflet is wrong or missing. 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?

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?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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