Medicines recallMHRA
Flucloxacillin Capsules BP 500mg recalled over a labelling error
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.
Check your product
Only products that match these details are covered. Have your pack in front of you.
3 identifiers listed for this notice.
Flucloxacillin Capsules BP 500mg 28 Capsules
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 1600636
- ExpiryOn the carton, blister or label.
- 31/08/2028
- First distributedOn the product, its label or its packaging.
- 19/05/2026
What to do now
There is an error on the label, carton or patient leaflet for Flucloxacillin Capsules BP 500mg.
- 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.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA 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
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.
Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/32). Quoted as issued.
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.
The risk
DMRC reference number DMRC-39902702 Marketing Authorisation Holder
Advice for healthcare professionals
Stop supplying the affected batch. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Patients should be aware that the Patient Information Leaflet (PIL) in a small number of packs of Flucloxacillin BP 500mg Capsules is incorrect. The affected packs contain the PIL for Amoxicillin 500mg Capsules instead of the PIL for Flucloxacillin 500mg Capsules.
Patients may continue to take the capsules as prescribed by your doctor as the quality of the capsules is not impacted by this defect.
No further action is required by patients. This recall is being undertaken as a precautionary measure and applies at Pharmacy and Wholesaler level.
The correct PIL may be found at: Click Here .
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 be aware that the Patient Information Leaflet (PIL) in a small number of packs of Flucloxacillin BP 500mg Capsules is incorrect. The affected packs contain the PIL for Amoxicillin 500mg Capsules instead of the PIL for Flucloxacillin 500mg Capsules.
Patients may continue to take the capsules as prescribed by your doctor as the quality of the capsules is not impacted by this defect.
No further action is required by patients. This recall is being undertaken as a precautionary measure and applies at Pharmacy and Wholesaler level.
The correct PIL may be found at: Click Here .
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 Flucloxacillin Capsules BP 500mg been recalled?
There is an error on the label, carton or patient leaflet for Flucloxacillin Capsules BP 500mg. 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?
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?
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.