RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48
Read and act on the official notice on GOV.UK
Class 3 recall — Action within 5 days.
The MHRA uses Class 3 when:
The defect is unlikely to cause harm to the patient.
What all four recall classes mean
| Class | Action | The MHRA's definition |
|---|---|---|
| Class 1 | Immediate action | The defect presents a risk of death or disability. |
| Class 2 | Action within 48 hours | The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious. |
| Class 3 this recall | Action within 5 days | The defect is unlikely to cause harm to the patient. |
| Class 4 | Caution in use | Usually minor defects in packaging or other printed materials. |
A Class 1 recall usually comes with a National Patient Safety Alert. Source: MHRA, safety communications.
The MHRA's 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.
Affected batches
As listed by the MHRA, exactly as published. Always check against the GOV.UK notice before acting.
| Batch number | Expiry | Pack size | First distributed |
|---|---|---|---|
| Atorvastatin 20 mg Film-coated Tablets | |||
| PTF6133A | 30/11/2027 | 28 | 09/09/2025 |
| Atorvastatin 80 mg Film-coated Tablets | |||
| PTF5991D | 30/11/2027 | 28 | 19/08/2025 |
| PTF5991F | 30/11/2027 | 28 | 27/08/2025 |
MHRA's audience tags: Dispensing GP practices, Pharmacy