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Medicines recallMHRA

Utrogestan Vaginal 200 mg Capsules (progesterone) recalled over a labelling error

Labelling or leaflet errorHigh riskClass 2

Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for certain batches of Utrogestan Vaginal 200 mg Capsules. The carton label references ‘micrograms’ where it should actually state ‘milligrams’.

Check your product

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

13 identifiers listed for this notice.

  • Utrogestan Vaginal 200 mg Capsules (progesterone) 21

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 234376/A
    • 241347/A
    • 234376/B
    • 241347/B
    • 241347/C
    • 241347/D
    ExpiryOn the carton, blister or label.
    • 30/09/2026
    • 30/04/2026
    First distributedOn the product, its label or its packaging.
    • 12/06/2024
    • 25/09/2024
    • 24/10/2024
    • 26/11/2024
    • 27/02/2025

What to do now

A printing or labelling mistake affects some packs of Utrogestan Vaginal 200 mg Capsules (progesterone).

  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

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/13). Quoted as issued.

Summary

Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for certain batches of Utrogestan Vaginal 200 mg Capsules. The carton label references ‘micrograms’ where it should actually state ‘milligrams’.

The risk

DMRC reference number DMRC-35159465 Marketing Authorisation Holder

Advice for healthcare professionals

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

No further action is required by patients as this is a pharmacy and wholesaler level recall.

Patients should note that the correct typography ‘mg’ is referenced elsewhere on the carton label, as well as on the blister label and inside the PIL.

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

No further action is required by patients as this is a pharmacy and wholesaler level recall.

Patients should note that the correct typography ‘mg’ is referenced elsewhere on the carton label, as well as on the blister label and inside the PIL.

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 Utrogestan Vaginal 200 mg Capsules (progesterone) been recalled?

A printing or labelling mistake affects some packs of Utrogestan Vaginal 200 mg Capsules (progesterone). 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?

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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