Healthcare professionals have been instructed to stop supplying a specific batch of the common antibiotic Flucloxacillin and return it to the supplier after a packaging error was discovered. The Medicines and Healthcare products Regulatory Agency (MHRA) issued a recall notice for certain packs of Flucloxacillin Capsules BP 500mg, manufactured by Flamingo Pharma UK Ltd, because they contain an incorrect patient information leaflet (PIL). Instead of the Flucloxacillin leaflet, the affected packs include the leaflet for Amoxicillin 500mg Capsules.
What is Flucloxacillin and Who Uses It?
Flucloxacillin is a penicillin-type antibiotic used to treat skin and soft tissue infections such as cellulitis and infected wounds, as well as infected eczema. It is also prescribed for bone and ear infections. The medication is available only on prescription, and in the UK, over 3 million prescriptions are issued annually to approximately 1.6 million patients.
Details of the Recall
The recall applies to batch number 1600636, with an expiry date of 31 August 2028. The pack size is 28 capsules, and the batch was first distributed on 19 May 2026. Flamingo Pharma UK Ltd informed the MHRA that the number of impacted packs is estimated to be low, but the recall is being conducted as a precautionary measure.
The government recall notice states: "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 and Patients
Healthcare professionals are advised to stop supplying the affected batch, quarantine all remaining stock, and return it to their supplier using the supplier’s approved process. Patients who have received the affected packs should be informed that the leaflet is incorrect, but they may continue taking the capsules as prescribed, since the quality of the capsules themselves is not affected.
The notice adds: "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 here."
Patients who experience any adverse reactions or have questions about their medication should seek medical attention. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.
