The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall notice for a specific batch of Flucloxacillin capsules, a commonly prescribed antibiotic. Pharmacies and wholesalers have been instructed to stop supplying the affected batch and return any remaining stock to their supplier. The recall, issued by Flamingo Pharma UK Ltd, is a precautionary measure due to an error in the patient information leaflets (PILs).
Incorrect Leaflets Found in Flucloxacillin Packs
Flamingo Pharma UK Ltd notified the MHRA that certain packs of Flucloxacillin Capsules BP 500mg contain PILs intended for Amoxicillin 500mg Capsules instead of the correct Flucloxacillin leaflet. The affected batch is identified by batch number 1600636, with an expiry date of 31/08/2028. The packs contain 28 capsules and were first distributed on May 19, 2026.
Flucloxacillin is a penicillin-based antibiotic prescribed for infections such as cellulitis, infected eczema, bone infections, and ear infections. According to reports, it is issued over 3 million times annually to approximately 1.6 million patients in the UK.
Recall as a Precautionary Measure
The recall notice stated: "Flamingo Pharma UK Ltd estimate that the number of impacted is low, however as a precautionary measure, this batch is being recalled." The guidance for healthcare professionals is clear: "Stop supplying the affected batch. Quarantine all remaining stock and return it to your supplier using your supplier's approved process."
Patients are advised that they may continue taking the capsules as prescribed, as the quality of the capsules themselves is not affected by the leaflet error. The notice clarified: "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."
Patient Advice and Reporting Adverse Reactions
Patients who have any concerns or experience adverse reactions should seek medical attention. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme. The correct PIL for Flucloxacillin can be accessed online if needed.
This recall applies at the pharmacy and wholesaler level, meaning patients do not need to return their medication. The MHRA and Flamingo Pharma UK Ltd emphasize that this is a precautionary step to ensure patient safety.
