South African regulators warn over unregistered GLP-1 injections

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South African regulators SAHPRA, SAPC and HPCSA jointly warned that recalled iDEXIS semaglutide, tirzepatide and combined products pose a severe patient safety risk and said healthcare professionals who continue prescribing or stocking them may face disciplinary action. SAHPRA issued a Class I, Type A recall after a May inspection found illegal importation of active pharmaceutical ingredients, no identity, potency or purity testing, inadequate sterile manufacturing and no pharmacovigilance despite reports of hospitalizations. iDEXIS disputes the findings and says its APIs are from approved manufacturers and independently tested; a court found the company manufactured unregistered semaglutide.

Regulators recalled iDEXIS GLP-1 injections for safety breaches.