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Medicines recallMHRA

Prednisolone 5mg Soluble Tablets recalled over a packaging defect

Packaging or device defectMedium riskClass 3

Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets becoming swollen over time.

Check your product

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

5 identifiers listed for this notice.

  • Prednisolone 5mg Soluble Tablets 30

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 2409006
    • 2409007
    ExpiryOn the carton, blister or label.
    • 31/05/2027
    First distributedOn the product, its label or its packaging.
    • 06/03/2025
    • 06/05/2025

What to do now

The problem with Prednisolone 5mg Soluble Tablets is the pack or device, such as a syringe, cap, blister or inhaler.

  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. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

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(25)A/54). Quoted as issued.

Summary

Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets becoming swollen over time.

The risk

DMRC reference number DMRC-37820855 Marketing Authorisation Holder

Advice for healthcare professionals

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

Activase Pharmaceuticals Limited have confirmed that this issue is limited to the batches listed in this notification and that no other batches are affected.

Patients should continue to take the medication from these batches unless the blister strips exhibit signs of swelling as the quality of the tablets will not be impacted. If you have received one of the batches of medication and the blister strip exhibits swelling, return it to your dispensing pharmacy. If you have any concerns about your medication speak to your pharmacy in the first instance.

This recall is being actioned at pharmacy and wholesaler level as a precautionary measure.

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 continue to take the medication from these batches unless the blister strips exhibit signs of swelling as the quality of the tablets will not be impacted. If you have received one of the batches of medication and the blister strip exhibits swelling, return it to your dispensing pharmacy. If you have any concerns about your medication speak to your pharmacy in the first instance.

This recall is being actioned at pharmacy and wholesaler level as a precautionary measure.

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 Prednisolone 5mg Soluble Tablets been recalled?

The problem with Prednisolone 5mg Soluble Tablets is the pack or device, such as a syringe, cap, blister or inhaler. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

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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