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Medicines defect noticeMHRA

Mirtazapine 30mg Tablets defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Cadila Pharmaceuticals Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of Mirtazapine 30mg Film-Coated Tablets distributed in Crescent Pharma Limited livery.

Check your product

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

3 identifiers listed for this notice.

  • Mirtazapine 30mg Tablets 28b

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • ET570E5012
    ExpiryOn the carton, blister or label.
    • 08/2028
    First distributedOn the product, its label or its packaging.
    • 09/04/2026

What to do now

The issue with Mirtazapine 30mg Tablets is information: something on the packaging or leaflet is wrong or missing.

  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. 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/28). Quoted as issued.

Summary

Cadila Pharmaceuticals Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of Mirtazapine 30mg Film-Coated Tablets distributed in Crescent Pharma Limited livery.

The risk

DMRC reference number DMRC - 39523288 Marketing Authorisation Holder

Advice for healthcare professionals

Do not to use this batch of medicine in robotic or automated dispensing or stock control systems. Healthcare professionals and recipients of this notification are advised not to use this batch of medicine in robotic or automated dispensing or stock control systems and to carry out manual dispensing and stock control, as appropriate.

No action is needed from patients, continue to take medication from this batch as prescribed by your healthcare professional. The issue is related to the wrong barcode on the cartons of the listed batch of Mirtazapine 30mg Tablets and will be controlled by the healthcare professionals prescribing/dispensing the medication. The quality of the tablets is not affected.

Patients should continue to take medicines from this batch as prescribed by 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

No action is needed from patients, continue to take medication from this batch as prescribed by your healthcare professional. The issue is related to the wrong barcode on the cartons of the listed batch of Mirtazapine 30mg Tablets and will be controlled by the healthcare professionals prescribing/dispensing the medication. The quality of the tablets is not affected.

Patients should continue to take medicines from this batch as prescribed by 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 Mirtazapine 30mg Tablets been recalled?

The issue with Mirtazapine 30mg 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?

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?

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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