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Medicines defect noticeMHRA

Omeprazole products 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 (SmPCs) of the specific products listed in this notification.

Check your product

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

138 identifiers listed for this notice.

  • Product 1 28

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • NR7436
    • NP0188
    • NP6341
    • NP0340
    • NP0338
    • NP0196
    • NP6261
    • NP6340
    • NP0192
    • NN5783
    • NN7643
    • NM4605
    • NM1246
    • NK4294
    • NK2489
    • NK2486
    • NK2484
    • NJ0183
    • NJ0182
    • NJ6114
    • NJ5014
    • NJ6113
    • NJ0179
    • NJ0180
    • NJ0181
    • NH7770
    • NH7771
    • NH2809
    • NG8624
    • NG8998
    • NG8621
    • NG4125
    • NG4126
    • NG2539
    • NW2409
    • NP6342
    • NR2911
    • NT3562
    • NT4728
    • NT7236
    • NT9384
    • NS2301
    • NM8348
    • NG6059
    • NE9955
    • NX3026
    • NR1768
    • NR1766
    • NH0584
    • NH0585
    • NJ8635
    • NH0587
    • NH0583
    Product licenceThe PL number on the carton.
    • PL 04416/0651
    • PL 04416/0652
    • PL 04416/1077
    • PL 04416/1078
    • PL 04416/1079
    • PL 04416/0701
    ExpiryOn the carton, blister or label.
    • 31/08/2025
    • 31/10/2025
    • 30/09/2025
    • 31/07/2025
    • 30/06/2025
    • 31/05/2025
    • 30/11/2025
    • 30/04/2025
    • 31/12/2024
    • 31/10/2024
    First distributedOn the product, its label or its packaging.
    • 24/06/2024
    • 23/04/2024
    • 11/07/2024
    • 30/06/2024
    • 26/06/2024
    • 30/05/2024
    • 03/07/2024
    • 05/07/2024
    • 29/04/2024
    • 28/03/2024
    • 13/06/2024
    • 18/03/2024
    • 17/03/2024
    • 24/02/2024
    • 12/03/2024
    • 20/02/2024
    • 19/01/2024
    • 01/02/2024
    • 22/01/2024
    • 16/02/2024
    • 28/02/2024
    • 14/02/2024
    • 18/01/2024
    • 29/01/2024
    • 17/01/2024
    • 11/01/2024
    • 08/01/2024
    • 01/12/2023
    • 12/12/2023
    • 21/12/2023
    • 27/11/2023
    • Not yet distributed
    • 06/03/2024
    • 04/01/2024
    • 04/09/2023
    • 09/05/2024
    • 05/04/2024
    • 11/12/2023
    • 16/01/2024
    • 29/11/2023
    • 19/10/2023

  • Product 2 100

    Batch code
    • NK2790
    Expiry
    • 31/05/2025
    First distributed
    • 24/04/2024

  • Product 3 7

    Batch code
    • NR1765
    • NC2107
    Expiry
    • 31/10/2025
    • 31/12/2024
    First distributed
    • 28/03/2024
    • 16/07/2023

  • Product 4 1

    Batch code
    • NH1463
    • NH1462
    • NH1464
    • NF5853
    • NA0066
    • NA0068
    • NA0074
    • NK2237AA
    Expiry
    • 31/07/2025
    • 28/02/2025
    • 31/08/2025
    First distributed
    • 30/05/2024
    • 04/06/2024
    • 09/01/2024
    • 26/10/2023
    • 11/08/2023
    • 02/11/2023
    • 08/02/2024
    • Not yet distributed

What to do now

The issue with Omeprazole products 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(24)A/34). 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 (SmPCs) of the specific products listed in this notification.

The risk

DMRC reference number DMRC 31246876 Company name

Advice for healthcare professionals

There is no risk to product quality or safety of the medicines because of this missing information. Therefore the affected batches are not being recalled. Due to supply considerations, batches listed as not yet distributed will not be repackaged with the updated PIL prior to distribution. The specified ‘Not yet distributed’ batches are scheduled to be distributed in the future to avoid any supply considerations

Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing. If any of the above products are supplied and/or dispensed, please ensure that patients are aware of the missing information as highlighted above. It is important that any patients who notice relevant symptoms (see information in the ‘Advice for Patients’ section) should seek immediate medical advice. The following is a link to the updated SmPC:

Omeprazole 10mg gastro-resistant capsules (PL 04416/0651):

Omeprazole 10mg Capsules - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Omeprazole 20mg gastro-resistant capsules (PL 04416/0652):

Omeprazole 20mg Capsules - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Mezzopram 10mg dispersible gastro-resistant tablets (PL 04416/1077):

Mezzopram 10 mg Dispersible Gastro-resistant Tablets - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Mezzopram 20mg dispersible gastro-resistant tablets (PL 04416/1078):

Mezzopram 20 mg Dispersible Gastro-resistant Tablets - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Mezzopram 40mg dispersible gastro-resistant tablets (PL 04416/1079):

Mezzopram 40 mg Dispersible Gastro-resistant Tablets - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Advice for patients

Omeprazole can very rarely cause certain conditions that result in skin reactions like widespread rashes, peeling skin, scaly skin, bumps, blisters, or redness. These conditions can also cause other symptoms like fever and swollen lymph nodes, which you can feel as lumps under the skin. These conditions are known as ‘drug reaction with eosinophilia and systemic symptoms’ (DRESS) and ‘acute generalized exanthematous pustulosis’ (AGEP), and they occur in about 1 out of every 10,000 to 1,000 patients taking omeprazole. Information about these conditions is missing from the Patient Information Leaflet that comes with your medicine. This does not change or affect the quality of the product, you can safely continue your treatment. Should you experience any skin reactions during or after treatment, or if you have any other unusual symptoms such as high temperature, lumps or feeling unwell please contact your healthcare professional as soon as possible.

If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. If you have concerns about a medicine you may be using, 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 Omeprazole products been recalled?

The issue with Omeprazole products 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, 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?

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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