Health regulators warn against recalled weight-loss medicines, threaten disciplinary action

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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:

ProductBatch numberExpiry
iDEXIS Tirzepatide 15mg penP2600170September 2026
iDEXIS Tirzepatide 10mg penP2600169September 2026
iDEXIS Tirzepatide 5mg penP2600175March 2026 and September 2026*
iDEXIS Semaglutide 2mg penP2600151September 2026
iDEXIS Semaglutide 1mg penP2600161September 2026
iDEXIS Semaglutide 0.5mg penP2600153September 2026
iDEXIS Semaglutide/Tirzepatide combination productsAll batchesAll 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.

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