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Medicines defect noticeMHRA

Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.

Check your product

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

37 identifiers listed for this notice.

  • Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets 28

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 1404515
    • 1404539
    • 1404540
    • 1404546
    • 1404721
    • 1404722
    • 1404628
    • 1404630
    • 1404631
    • 1404632
    • 1404640
    • 1404641
    • 1404629
    • 1404615
    • 1404616
    • 1404626
    • 1404627
    • 1404724
    • 1404723
    ExpiryOn the carton, blister or label.
    • 31/12/2025
    • 31/03/2026
    • 28/02/2026
    • 31/01/2026
    • 30/04/2026
    First distributedOn the product, its label or its packaging.
    • 10/03/2023
    • 29/03/2023
    • 26/05/2023
    • 30/05/2023
    • 18/07/2023
    • 19/07/2023
    • 19/05/2023
    • 22/05/2023
    • 21/06/2023
    • 10/08/2023
    • 17/05/2023
    • 15/06/2023
    • 10/07/2023

What to do now

A printing or labelling mistake affects some packs of Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets.

  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

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(25)A/52). Quoted as issued.

Summary

Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.

The risk

DMRC reference number DMRC - 37698206 Marketing Authorisation Holder

Advice for healthcare professionals

The issue impacts all batches of Flamingo Pharma UK Ltd Amitriptyline Hydrochloride 10mg, 25mg and 50mg Film Coated Tablets. The Patient Information Leaflet for these batches contains out of date safety information, i.e. missing safety information concerning the following:

Serotonin Syndrome

Dry Eye

There is no risk to product quality or impact to safety of the medicines listed in this notification.

Healthcare professionals are advised to review the information contained within this notification and take this into account when dispensing this product, especially for new patients.

Please note that all further Flamingo Pharma UK Ltd batches of Amitriptyline HCl 10mg, 25mg and 50mg Film Coated Tablets with an expiry date of 31 May 2026 onwards contains the correctly updated safety information in the PIL.

Upon request, Flamingo Pharma UK Ltd will provide hard copies of the updated PIL to pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact quality@flamingopharma.co.uk with your details, i.e. address, product with batch details, required number of leaflets.

Patients should be aware that all batches of Flamingo Pharma UK Ltd Amitriptyline Hydrochloride 10mg, 25mg and 50mg Film Coated Tablets contain an incorrect Patient Information Leaflet (PIL), with missing safety information. The missing safety information is listed in this notification and if you have any additional concerns relating to this information, please contact your pharmacist or prescriber.

The missing information, summarised in this notification, does not change or affect the quality of the product. Patients can continue to safely take this medicine unless they have concerns related to the missing information.

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 should be aware that all batches of Flamingo Pharma UK Ltd Amitriptyline Hydrochloride 10mg, 25mg and 50mg Film Coated Tablets contain an incorrect Patient Information Leaflet (PIL), with missing safety information. The missing safety information is listed in this notification and if you have any additional concerns relating to this information, please contact your pharmacist or prescriber.

The missing information, summarised in this notification, does not change or affect the quality of the product. Patients can continue to safely take this medicine unless they have concerns related to the missing information.

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 Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets been recalled?

A printing or labelling mistake affects some packs of Amitriptyline Hydrochloride 10mg, 25mg, 50mg 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, 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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