Class 3 Medicines Recall: Flamingo Pharma UK Ltd, Flucloxacillin Capsules BP 500mg, EL(26)A/32
Read and act on the official notice on GOV.UK
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.
In plain English, for the pharmacy team
Why is this relevant to community pharmacy
Flucloxacillin Capsules blood pressure (BP) 500mg is an antibiotic. Some packs contain the wrong patient leaflet, with the leaflet for amoxicillin capsules instead. This affects pharmacy supply because the affected batch may still be in stock and must not be supplied.
What to tell patients
Use your professional judgement for each patient.
- The leaflet in a small number of packs is wrong and may say amoxicillin instead of flucloxacillin.
- You may keep taking the capsules as prescribed by your doctor.
- No further action is needed.
- If you have any questions about your medicine, or if you have a bad reaction, seek medical attention.
- Report suspected bad reactions through the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme.
What needs to be done
- Stop supplying the affected batch.
- Quarantine all remaining stock of the affected batch.
- Return it to your supplier using your supplier’s approved process.
- Pharmacists: if patients ask, explain that the capsules themselves are not affected, but the patient leaflet in some packs is wrong.
- Pharmacists: note that any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.
- Read and act on the official GOV.UK notice.
Pharmshark summary, checked and approved by Chris Dotchin on 2 Nov 2026. It is not the official notice: always read and act on the GOV.UK notice.
How this summary was written
An AI tool drafted it from the MHRA's own notice and nothing else. A second check compared every line with the notice. Pharmshark's clinical lead then read it against the notice, edited it where needed and approved it. If the MHRA changes the notice, this summary is taken down until it has been checked again.
The MHRA's summary
Flamingo Pharma UK Ltd have informed the MHRA that certain packs of Flucloxacillin Capsules BP 500mg contain the incorrect PIL. The affected packs contain the PIL for Amoxicillin 500mg Capsules instead of the PIL for Flucloxacillin BP 500mg Capsules.
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 |
|---|---|---|---|
| Flucloxacillin Capsules BP 500mg | |||
| 1600636 | 31/08/2028 | 28 Capsules | 19/05/2026 |
MHRA's audience tags: Dispensing GP practices, Pharmacy