An urgent warning has been issued for a widely used osteoporosis medication due to a labelling error on its packaging. The Medicines and Healthcare products Regulatory Agency (MHRA) has released a class 4 defect notification for Ponlimsi (denosumab) 60mg solution for injection in pre-filled syringes.
What Is the Issue?
The defect arises from incorrect wording on the cartons of three specific batches. The packaging erroneously states "For application to the skin," whereas the product is licensed for subcutaneous use—meaning it should be injected under the skin. Teva UK Limited, the marketing authorisation holder, reported the error.
Affected Batches
The following batch numbers are affected:
- 184472 – Expiry: 30/11/2028 – Distributed: 21/01/2026
- 186711 – Expiry: 30/11/2028 – Distributed: 21/04/2026
- 188656 – Expiry: 28/02/2029 – Distributed: 01/06/2026
No Quality Risk or Recall
The MHRA has confirmed that there is no risk to product quality from this labelling mistake. Apart from the label, no other errors have been identified with the product or its delivery device. Therefore, the affected batches are not being recalled. Teva UK Limited stated that all future deliveries will include a copy of this notification to remind healthcare professionals and patients that the product is for subcutaneous use.
Advice for Healthcare Professionals and Patients
Healthcare professionals are advised to reassure patients that the product is for injection as described in the patient information leaflet, which contains clear instructions for use. Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.
Background on Osteoporosis
Osteoporosis is a chronic condition that causes bones to become fragile, brittle, and porous. Often called the "silent disease," its symptoms may go unnoticed until a minor injury results in a broken bone. Ponlimsi is commonly used to treat postmenopausal women and men at increased risk of bone fractures, including those undergoing treatment for prostate cancer.
