News » MHRA alert » Alert: Ponlimsi (Denosumab) 60mg solution
June 8th 2026
Teva UK Limited is reporting a labelling error on three batches of Ponlimsi (Denosumab) 60mg solution for injection in pre-filled syringe. The carton states “For application to the skin” when the product is licensed for subcutaneous use.
The affected batches are:
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 184472 | 30/11/2028 | 1 pre-filled syringe | 21/01/2026 |
| 186711 | 30/11/2028 | 1 pre-filled syringe | 21/04/2026 |
| 188656 | 28/02/2029 | 1 pre-filled syringe | 01/06/2026 |
Affected batches commenced distribution from 21 January 2026. Affected batches are not being recalled.
Healthcare professionals can reassure patients that the product is for subcutaneous injection as described in the Patient Information Leaflet, which contain clear instructions for intended use. Patients should continue to use syringes from these batches as prescribed.
The Summary of Product Characteristics and Patient Information Leaflet can be accessed online.
For all medical information enquiries and information on this product, please email medinfo@tevauk.com
For stock control enquiries please email Customer.services@tevauk.com
