South African health regulators have ordered the immediate recall of several compounded GLP-1 medicines, warning that the products pose a serious risk to patient safety and should no longer be prescribed, dispensed or used.
The recall was announced by the South African Health Products Regulatory Authority (SAHPRA) in partnership with the South African Pharmacy Council (SAPC) and the Health Professions Council of South Africa (HPCSA).
The action targets compounded medicines manufactured by iDexis, which operates as Sentra Pharmacy in Pretoria, and comes as demand for GLP-1 weight-loss and diabetes treatments continues to grow rapidly in South Africa.
The recalled products include iDEXIS Semaglutide, iDEXIS Tirzepatide, and combination formulations containing both active ingredients.
SAHPRA classified the action as a Class I, Type A recall, indicating that the products present a serious safety risk to patients.
Regulators Warn of Legal Consequences
Health authorities have instructed doctors, pharmacists and healthcare facilities to stop prescribing, dispensing and stocking the recalled medicines immediately.
According to SAHPRA, any healthcare professional who continues to supply or prescribe the recalled products could face disciplinary action under the Medicines and Related Substances Act, 101 of 1965, as well as sanctions from professional regulatory bodies.
SAPC Chief Executive Officer Vincent Tlala told Reuters that regulators escalated enforcement after determining that iDexis had not completed the recall as required.
He said pharmacists who continue dispensing the products could face fines ranging from R25,000 to R75,000. If patients are found to have suffered harm, practitioners could also face disciplinary hearings and possible removal from the professional register.
Court Case Highlights Growing GLP-1 Market
The regulatory action follows an interim High Court order granted last month prohibiting iDexis from manufacturing and selling medicines containing semaglutide.
The court order resulted from legal action brought by Danish pharmaceutical company Novo Nordisk, which manufactures Ozempic and Wegovy.
Novo Nordisk argued that iDexis was manufacturing and marketing unregistered semaglutide products while competing in South Africa’s expanding weight-loss market without complying with medicine registration requirements.
Semaglutide is the active ingredient in Ozempic and Wegovy, while tirzepatide is the active ingredient used in Eli Lilly’s Mounjaro and Zepbound.
Following the court ruling, Novo Nordisk South Africa General Manager Sara Norcross said the judgment reinforced concerns about the potential risks associated with unregulated compounded GLP-1 medicines.
Health authorities stressed that the recall applies only to the compounded iDexis products and does not affect registered medicines manufactured and supplied by the original pharmaceutical companies, including Ozempic, Wegovy and Mounjaro.
Regulators have urged patients currently using the recalled medicines to consult their healthcare providers before making changes to their treatment.
Source: South African Health Products Regulatory Authority (SAHPRA); South African Pharmacy Council (SAPC); Reuters. (This article is based on official statements and publicly available court information.)