South Africa’s three leading health regulators have issued a warning to the public and healthcare professionals not to use, prescribe or dispense recalled iDEXIS weight-loss medicines, saying those who ignore the recall could face disciplinary action.
In a joint statement, the South African Pharmacy Council (SAPC), the Health Professions Council of South Africa (HPCSA) and the South African Health Products Regulatory Authority (SAHPRA) said the continued use of recalled iDEXIS Semaglutide, iDEXIS Tirzepatide and iDEXIS Semaglutide/Tirzepatide combination products poses a serious risk to patient safety.
The medicines were recalled by SAHPRA in June following an inspection at iDEXIS, trading as Sentra Pharmacy in Silverton, Pretoria.
SAHPRA classified the action as a Class I, Type A recall – the most serious type of medicine recall – after identifying potential safety concerns during a joint inspection with the SAPC.
The regulator said it seized compounded semaglutide and tirzepatide products at the pharmacy and ordered the recall of all affected products already distributed. The recall applies not only to listed batches but also to unknown batches that may have been supplied before the inspection.
Health authorities have warned that any healthcare professional who continues to prescribe, dispense or keep stock of the recalled products could face disciplinary action under the Medicines and Related Substances Act.
Patients who have the recalled medicines are urged to stop using them immediately and return them to the pharmacy or healthcare provider that supplied them. iDEXIS has undertaken to collect returned stock and reimburse pharmacies and healthcare providers.
SAHPRA is also encouraging patients and healthcare professionals to report any side effects linked to the recalled medicines through its Med Safety reporting system.
The recalled iDEXIS products include the following:
| Product | Batch number | Expiry |
|---|---|---|
| iDEXIS Tirzepatide 15mg pen | P2600170 | September 2026 |
| iDEXIS Tirzepatide 10mg pen | P2600169 | September 2026 |
| iDEXIS Tirzepatide 5mg pen | P2600175 | March 2026 and September 2026* |
| iDEXIS Semaglutide 2mg pen | P2600151 | September 2026 |
| iDEXIS Semaglutide 1mg pen | P2600161 | September 2026 |
| iDEXIS Semaglutide 0.5mg pen | P2600153 | September 2026 |
| iDEXIS Semaglutide/Tirzepatide combination products | All batches | All affected batches |
*The recall notice lists batch P2600175 with both March 2026 and September 2026 expiry dates.
Importantly: SAHPRA says the recall is not limited to these batch numbers. It applies to all Semaglutide, Tirzepatide and Semaglutide/Tirzepatide combination products compounded by iDEXIS (Pty) Ltd trading as Sentra Pharmacy, including unknown batches that were distributed before the inspection. Patients are advised to stop using these products immediately and return them to the dispensing pharmacy or healthcare provider.
