MHRA Class 2 Medicines Recall: Fucidin 250 mg Tablets, LEO Laboratories Ltd trading as LEO Pharma
Drug alert number: EL(25)A/38
Date issued: 04 August 2025
LEO Pharma is recalling the affected batch as a precautionary measure due to out of specification results for impurities during routine stability testing.
DMRC reference number: DMRC-36306427
Company name: LEO Laboratories Ltd trading as LEO Pharma
Medicine Details
Fucidin 250 mg Tablets
PL: 00043/5000R
Active ingredient: Sodium Fusidate
SNOMED code: 3670711000001108
GTIN: 05702191000931
Affected Lot Batch Numbers:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| D00993 | 31/01/2026 | 10 x 10 | 13/07/2023 |
Background
LEO Pharma is recalling the affected batch as a precautionary measure due to out of specification results for impurities during routine stability testing.
Advice for Healthcare Professionals
Stop supplying the above batch immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.
LEO Pharma can confirm 1,848 packs of this batch have been released and distributed. No related adverse event reports or product quality complaints have been received related to this defect.
View the full alert here.
Advice for Patients
No further action is required by patients as this is a Pharmacy and Wholesaler level recall related to a specific batch of Fucidin 250 mg Tablets.
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.
Additional information
For all enquiries and information on this product, please email medical-info.uk@leo-pharma.com or telephone 01844 347 333 and press 2 for Medical Information.
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