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Medicines recallMHRA

Atorvastatin 20mg and 80mg Film-coated Tablets recalled over a strength or dose problem

Wrong strength or doseMedium riskClass 3

Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.

Check your product

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

7 identifiers listed for this notice.

  • Atorvastatin 20mg and 80mg Film-coated Tablets 28

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • PTF6133A
    • PTF5991D
    • PTF5991F
    ExpiryOn the carton, blister or label.
    • 30/11/2027
    First distributedOn the product, its label or its packaging.
    • 09/09/2025
    • 19/08/2025
    • 27/08/2025

What to do now

Atorvastatin 20mg and 80mg Film-coated Tablets has been recalled because test results for the affected batches were outside the approved limits for strength or how the medicine dissolves.

  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. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

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/48). Quoted as issued.

Summary

Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.

The risk

DMRC reference number DMRC - 37494064 Marketing Authorisation Holder

Advice for healthcare professionals

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

Patients should continue to take medicines as prescribed by your healthcare professional. The recall is being actioned at the wholesaler level as a precautionary measure. No complaints of harm or lack of efficacy have been received from patients regarding this batch.

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 medicines as prescribed by your healthcare professional. The recall is being actioned at the wholesaler level as a precautionary measure. No complaints of harm or lack of efficacy have been received from patients regarding this batch.

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 Atorvastatin 20mg and 80mg Film-coated Tablets been recalled?

Atorvastatin 20mg and 80mg Film-coated Tablets has been recalled because test results for the affected batches were outside the approved limits for strength or how the medicine dissolves. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

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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