Flamingo Pharma UK Ltd has notified the Medicines and Healthcare products Regulatory Agency (MHRA) that certain packs of Flucloxacillin Capsules BP 500mg contain the incorrect patient information leaflet.
Affected packages contain the patient information leaflet for Amoxicillin 500mg Capsules, instead of the information regarding Flucloxacillin BP 500mg Capsules.
The MHRA has subsequently published a class 3 medicines recall.
The recall notification read: “Flamingo Pharma UK Ltd estimate that the number of impacted is low however as a precautionary measure, this batch is being recalled.”
Recalled batch
The recalled batch is Flucloxacillin Capsules BP 500mg, with the active ingredient flucloxacillin sodium:
- Batch number: 1600636
- Expiry date: 31/08/2028
- Pack size: 28 Capsules
- First distributed: 19/05/2026
Advice for healthcare professionals
The Royal College of Pharmacy wrote on the recall: “Pharmacists are advised to stop supplying the affected batch, quarantine all remaining stock and return it to your supplier using your supplier’s approved process.”
Further, the MHRA has asked NHS regional teams to forward the medicines recall notification to community pharmacists and dispensing general practitioners for information.
The Agency said that any suspected adverse reactions should be reported via the MHRA Yellow Card Scheme.
Patient information leaflets
This is not the first time that Flamingo Pharma has experienced issues with the recall of incorrect patient information leaflets.
The recall follows a defect notification, issued by the MHRA at the end of 2025, for multiple batches of Flamingo Pharma UK’s amitriptyline hydrochloride 10mg, 25mg and 50mg tablets.
This was due to patient information leaflets supplied in the packets not containing safety information on the risk of serotonin syndrome when taken with buprenorphine, as well as omitting dry eye as a possible side effect.
The MHRA said that there was no risk to product quality or impact to safety of the medicines listed in the notification.
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