MHRA Class 3 Medicines Recall: Flucloxacillin Capsules BP 500mg (Flamingo Pharma UK Ltd)
MHRA Class 3 Medicines Recall: Flucloxacillin Capsules BP 500mg (Flamingo Pharma UK Ltd)
Drug Alert Number: EL(26)A/32
Date issued: 30 June 2026
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.
Marketing Authorisation Holder: Flamingo Pharma UK Ltd
Medicine Details
Product name: Flucloxacillin Capsules BP 500mg (PL: 43461/0071).
Active ingredient: flucloxacillin sodium
SNOMED code: 42544111000001101
GTIN: 5060464503320
Affected Lot Batch Numbers
| Batch number | Expiry date | Pack size | First distributed |
| 1600636 | 31/08/2028 | 28 Capsules | 19/05/2026 |
Background
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. Flamingo Pharma UK Ltd estimate that the number of impacted is low however as a precautionary measure, this batch is being recalled.
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.
View the full alert here.
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.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Additional information
For all medical information enquiries and information on this product, please email safety@flamingopharma.co.uk, or telephone +44 (0) 800 0668 348.
For stock control enquiries please email sales@flamingopharma.co.uk, or telephone +44 (0) 7784 240228
